Methods

Cluster randomised controlled trial

Randomisation ratio: initially 1 : 1 : 1, final 5 sites randomised 1 : 2 : 2 owing to higher drop‐out in the practices providing the 2 interventions

Superiority design

Participants

Inclusion criteria: aged 2‐8 years with a BMI ≥ 85th and ≤ 97th percentile based on Centers for Disease Control cut‐points (reference provided)

Exclusion criteria: type 1 or type 2 diabetes, non‐English‐speaking parent, no working telephone, chronic medical disorders, chromosomal disorders, syndromes and non‐ambulatory conditions, medications known to affect growth, enrolment in a weight loss programme, seen by weight loss specialist in past 12 months

Diagnostic criteria: as above

Interventions

Number of study centres: ‐

Treatment before study: ‐

Titration period: ‐
Description of interventions:

BMI2 (Brief Motivational Interviewing to reduce body mass index):

1. Moderate‐intensity (4 sessions, 3 in year 1) primary care providers (PCP) motivational interviewing (MI) based counselling. PCPs received 2 days of in‐person training in MI and behaviour therapy and an interactive MI DVD training. Provided counselling sessions with a parent of the index child in year 1 and 1 additional "booster" visit in year 2 as well as usual care (described below). MI uses specific techniques such as reflective listening, autonomy support, shared decision‐making, and eliciting change talk. Focused on discrete behaviours, such as snack foods, sweetened beverages, fruits, vegetables, TV/screen time and physical activity/exercise. Provided positive feedback for healthy behaviours and then, collaboratively with the parent, identify behaviours that might be modified. Pre‐existing or new materials written in a style consistent with MI and self determination theory. Content emphasised child choice in making behaviour change. Self monitoring logs could be used, clinicians educational materials and logs specific to the family

2. High‐Intensity, PCP and dietician, intervention. Same intervention components as moderate‐intensity group (4 sessions with PCP) but added 6 MI‐based counselling (4 in year 1) from a trained dietician. Sessions were delivered either in‐person or by telephone. Dieticians given same training in MI as the PCPs

3. Usual care: routine care by the PCP, as well as standard educational materials for parents on healthy eating and exercise. Practitioners attended a half‐day orientation session that included current treatment guidelines

PCPs and dieticians were incentivised for the number of sessions and the number of participants recruited additional payments for retaining 50% and 80% of cohort

Outcomes

Outcomes reported in abstract of publication: BMI percentile

Study details

Run‐in period: ‐

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "to test the efficacy of moderate‐intensity (4 sessions) PCP MI‐based counselling and the effect of adding 6 MI‐based counselling sessions by trained dietitians delivered to parents of overweight youth aged 2 to 8 years recruited through primary care offices"

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote from publication: "randomly assigned"

Comment: no details

Allocation concealment (selection bias)

Unclear risk

Comment: no details

Blinding of participants and personnel (performance bias)
Objective outcomes

High risk

Quote from publication: "open label"

Comment: investigator‐assessed

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Quote from publication: "open label"

Comment: investigator‐assessed, low risk of bias from objective outcomes

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: reported with reasons per practice

Selective reporting (reporting bias)

High risk

Comment: no secondary outcomes reported

Other bias

Low risk

Comment: no other bias

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: BMI ≥ the 85th percentile who primarily resided with the participating carer. Participants also had to speak English, be able to understand basic instructions and perform simple exercises

Exclusion criteria: carers: non‐ambulatory, pregnant or have a medical diagnosis that may be negatively impacted by exercise. Parents whose children have a medical condition or developmental disorder that precludes weight loss using conventional diet and exercise methods

Diagnostic criteria: BMI ≥ 85th percentile

Interventions

Number of study centres: not reported

Treatment before study: none

Titration period: none
Description of interventions

NOURISH parenting intervention

Based in Social Cognitive Theory (SCT), and emphasises parental role modelling as a primary way children learn health behaviours. Focuses on enhancing parents' self efficacy to make positive changes in eating and exercise behaviours. In addition, cognitive‐behavioural strategies such as self monitoring, contingency management and stimulus control incorporated. All sessions involved participatory activities, including self assessments, group discussions and experiential activities. These participatory experiences aimed to enhance overall intervention efficacy
The intervention also informed by Stages of Change Theory and is integrated into the intervention through regular self assessment of barriers to change as well as moderated discussions on the process (pros and cons) of engaging in a healthier lifestyle. Focus on the parents' relationship with everyone in the family, not just the "identified patient" or overweight child, as recommended by Golan and colleagues
Outline of NOURISH session content (each session was 90 minutes):
Session 1 ‐ overview of childhood eating problems and becoming an empowered parent; session 2 ‐ the "toxic environment": how can parents fight back?; Session 3 ‐ nutrition, portion sizes, fruits and vegetables; session 4 ‐ emotional and mindful eating; session 5 ‐ parenting styles; session 6 ‐ helping your child develop a healthy relationship with food; session 7 ‐ increasing physical activity; session 8 ‐ reducing physical activity barriers; session 9 ‐ promoting a healthy body image; session 10 ‐ dealing with teasing; session 11 ‐ raising a media‐savvy child; session 12 ‐ bringing it all together

All sessions led by doctoral students in psychology working under the supervision of a licensed, clinical psychologist with specific training in group facilitation.
Sessions were video‐recorded to allow the investigators to monitor treatment fidelity. Interventionists met weekly with the principal investigator for supervision. These meetings were used to review interventionists' adherence to the treatment protocol, to review programme retention, and to discuss participant interactions.

Parents had a 1‐hour booster session 2 months after the intervention to allow parents to share with one another their successes, and to elicit suggestions from group leaders and fellow parents regarding barriers they have encountered

Control parenting intervention

Parents in the control group attended a group session moderated by an independent interventionist (a doctoral student in psychology). The session addressed the role of diet and exercise in paediatric overweight. Control participants were mailed publicly available brochures on paediatric overweight on 3 occasions during the study: between weeks 4 and 5, between weeks 8 and 9, and 2 months after post‐testing (the latter of which was meant to match the NOURISH booster session)

Parents and children in both the intervention and control groups received a pedometer. Intervention parents also received a raffle ticket at each session for a USD 75 gift card, which will take place at the final session. Participants who attend the final session were given Certificates of Completion. All parents (i.e. intervention and control groups) were given USD 20 gift cards for completing the pre‐test, post‐test and the 6‐month follow‐up. The study provided childcare for all programme sessions and assessments

Outcomes

Outcomes reported in abstract of publication: child BMI, parents satisfaction, parent behaviour change

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "The primary aim of this study is to implement and evaluate the feasibility, acceptability, and preliminary effectiveness of NOURISH, a culturally sensitive, parent‐only skills‐based group intervention, and a single‐session, education‐only, control group (parent‐only) intervention on overweight children's BMI percentile. The secondary aim of this study is to evaluate the effectiveness of the intervention for improving children's dietary intake, body dissatisfaction, and quality of life. The impact of these two programs on adult participants will also be evaluated, including parental BMI and dietary intake. Parent satisfaction and feedback regarding the NOURISH intervention will also be elicited..."

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "Participants will be randomly assigned (using a random number generator) to one of two parent‐only interventions..."

Allocation concealment (selection bias)

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Subjective outcomes

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: carers in the control arm were blinded to the aims and hypotheses of this study otherwise no details masking of treatment assignment

Blinding of outcome assessment (detection bias)
Subjective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Subjective outcomes

Low risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: numbers of drop‐outs and withdraws provided and similar across groups. ITT analysis ‐ analysed all the data according to participants' assigned group, whether or not they actually completed the intervention. Used participants' most recent data as post intervention scores

Selective reporting (reporting bias)

High risk

Comment: many outcomes were collected but not reported ‐ though it was reported that these were not significantly different from baseline

Other bias

Unclear risk

Comment: although it was made clear why the trial team changed the protocol intervention time from 12 weeks to 6 weeks, this did not seem to help retain participants and meant if there was to be an effect it could not be shown in the health‐related quality of life of participants' children

Methods

Cluster randomised controlled trial

Randomisation ratio: 1 : 1

Superiority design:

Participants

Inclusion criteria: child classified as being overweight (not obese) according to international age and gender specific cut‐off points for BMI at the well‐child visit (country wide health visit in the year a child turns 5 years), attended between September 2007 and October 2008. Parents with at least basic Dutch language skills

Exclusion criteria: obese children with chronic health problems that many influence outcomes

Diagnostic criteria: not reported

Interventions

Number of study centres: 9 (44 teams)

Treatment before study: none

Titration period: none
Intervention description:

Parent‐only intervention: motivational interviewing if needed, with information about overweight prevention and healthy lifestyle choices. Initiated at the well‐child visit and up to 3 structured counselling sessions could be offered at approximately 3, 6 and 12 months later. The session content depended on the stage of behavioural change of the parents (individually tailored). Motivation was assessed by Youth Health Care professionals by creating awareness of the child's weight status and associated consequences. 4 lifestyle‐related behaviours could be promoted: playing outdoors, eating breakfast, reducing sweet drinks and sedentary behaviour. Parents choose 1 or 2 behaviours to target during the sessions. Advice was by international guidelines. Information materials provided, diet and activity diaries discussed and family‐oriented action plans to change health‐related behaviour documented

Youth Health care professionals were provided with a half‐day training in motivational interviewing techniques, were provided with a workbook with information and practical examples and an information sheet with step‐by‐step guide to how the information could be applied

Control group: parents informed of overweight of their child but usual care (general information about a healthy lifestyle) given

Outcomes

Outcomes reported in abstract of publication: BMI, minutes of outside play or TV viewing, having breakfast, number drinks of sweet beverages

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐review publication

Stated aim for study

Quote from publication: "Children who are overweight (not obese) visiting YHC teams…would have a less increase in BMI and waist circumference at follow‐up compared to overweight children visiting YHC teams allocated to the control condition, performing usual care"

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "within each centre, YHC teams were randomised... by means of a computer‐generated random number list… random permuted blocks… lengths were 4 or 6 depending on the number of teams per Municipal Health Service"

Allocation concealment (selection bias)

Unclear risk

Comment: no details of allocation concealment provided by study authors

Blinding of participants and personnel (performance bias)
Objective outcomes

Low risk

Quote from publication: "parents were not aware of the research condition they were allocated to"

Comment: personnel were aware of allocation. Investigator‐assessed outcomes

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Quote from publication: "... research assistants [measuring weight and height] were blinded to the research condition."

Incomplete outcome data (attrition bias)
Objective outcomes

Unclear risk

Comment: 2 clusters (1 per arm) not analysed. Also states used ITT, numbers analysed for BMI and waist circumference outcomes differ, assume because of ICC for clustering

Selective reporting (reporting bias)

Low risk

Comment: all outcomes stated are reported and response from study author concurs

Other bias

Unclear risk

Comment: 211 parent‐child dyads in the intervention group did not receive any of the counselling sessions

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: parents of overweight or obese 4‐ to 8‐year‐old

Exclusion criteria: children who had uncontrolled medical problems (e.g. asthma) that might preclude them from fully participating in the intervention

Diagnostic criteria: described only as overweight or obese

Interventions

Number of study centres: unclear

Treatment before study: none

Titration period: none
Description of interventions

Before each of the sessions for either group, parents were provided with age‐appropriate, audio‐taped, educational information on a range of topics. Each group had 4 face‐to‐face sessions held for 30‐60 minutes and 3 telephone calls between sessions (duration unclear)

Parent intervention:

Theoretically based intervention. Parents were offered educational information about the establishment of healthy habits in young children, nutritional information, information regarding increasing physical activity and decreasing sedentary time, and age‐specific information regarding the child's behaviour in response to change

4 face‐to‐face sessions during which trained research assistants used principles of brief motivational interviewing (i.e. elicit information from the participant, provide non‐judgemental information, and elicit the participant's understanding; to collaborate with parents on identifying specific realistic healthy lifestyle goals, developing clear steps to reach those goals, routinely having the parents re‐evaluate progress, and identifying new goals as needed)

Parents were provided with specific feedback about their child (i.e. physical activity and dietary intake) before establishing goals for their child and family. All face‐to‐face parent intervention sessions were separated by 4‐6 weeks to provide each family with time to enact planned changes, encounter child responses to those changes and review new educational information before the next face‐to‐face session

Telephone calls were made to each parent to:

• review the established goals and planned steps,

• check with the parent regarding progress toward planned changes,

• answer questions,

• encourage review of newly provided educational materials

• establish a date and time for the next face‐to‐face appointment.

At each of the 4 measurement time points, parents were offered USD 35 as remuneration for their time in completing the various measurements. Each child was given a group specific (e.g. treatment group and control group) bag of toys to facilitate activities that parents would be encouraged to complete with their child

Sessions taken by trained research assistants who were also supervised

Control:

Parents were provided with educational age‐appropriate, evidence‐based health and safety information (e.g. care for thermal injuries, first‐aid care, and care for insect bites and stings) that is specific to parenting in the southwest US. Parents met with a control interventionist and in a similar way were encouraged to make health and safety goals for their family (e.g. development of first‐aid materials and identification of a fire escape plan)
Telephone calls were made to each parent as described above

Outcomes

Outcomes reported in abstract of publication: waist circumference, waist‐by‐height ratio, BMI and BMI percentile

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "The purpose of this randomised control pilot study was to determine the feasibility and preliminary effects of a theoretically based, primary care intervention on the physical outcomes of 60 overweight/obese preschool/early school‐aged 4‐ to 8‐year‐old children..."

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote from publication: "each parent‐child dyad was randomly assigned to the treatment or control condition..."

Comment: no description provided

Allocation concealment (selection bias)

Unclear risk

Comment: no description provided

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Quote from publication: "Seven parent‐child dyads returned incomplete T1 data, and thus we removed data from those dyads from all other analyses. As a result, experimental and control group sample sizes were 33 and 27, respectively"

Comment: multiple imputation techniques to account for the missing data in subsequent analyses for the remaining 60 parent‐child dyads

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: not enough detail to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: 1 : 1

Superiority design

Participants

Inclusion criteria: aged 7 years, ≥ 95th percentile of BMI for age

Exclusion criteria: mental retardation, psychiatric symptoms, current obesity treatment, chronic disease and use of medication

Diagnostic criteria: obesity defined as BMI 95th percentile for age by 2000 reference standards

Interventions

Number of study centres: 1

Treatment before study: none

Titration period: none
Intervention description:

Parent‐only:

12 session training programme over 6 months

8 weekly sessions for the first 2 months, then 4 monthly sessions. Each session lasts 4 hours, including a review of parent progress in implementing strategies developed for changing child's eating or exercise habits, and the specific topic of the day, such as learning about the reasons of the childhood obesity, receiving nutritional information (e.g. food pyramid, food choices, food labels, food preparation and cooking, eating habits, regular meals, controlling environments that stimulate overeating, special dietary consideration during holidays and at the restaurants) and guidelines for physical activity and reducing sedentary behaviours (e.g. reduce watching TV and playing computer games, use stairs instead of lifts and play outside instead of inside)

Control:

2 sessions of training programme (occurred after intervention group's 6‐month training programme), no details provided

Outcomes

Outcomes reported in abstract of publication: weight, waist and hip circumference, cholesterol, serum triglycerides, food group consumption, TV and computer time, walking time

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Peer review publication

Stated aim for study

Quote from publication: "to assess the effect of lifestyle modification family‐based intervention in young Iranian children"

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote from publication: "children got a code number and were randomly divided into two groups"

Comment: randomly assigned

Allocation concealment (selection bias)

Unclear risk

Comment: not enough information to judge

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: adjudicated/investigator‐assessed, no other details

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: numbers only reported, numbers in flow chart and results do not match, differential drop‐out rates

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: not enough information to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: child aged 6‐12 years, 20‐85% overweight, medical clearance form a physician

Exclusion criteria: secondary overweight caused by endocrinological, chromosomal or hypothalamic disease or mental retardation

Diagnostic criteria: as above

Interventions

Number of study centres: 1

Treatment before study: none

Titration period: none
Intervention description:

Parent‐only intervention:

6 group meetings of 2 hours each over a 5‐month period. Provided information with a focus on weight control not weight loss to re‐establish a sense of healthy balance between energy intake and energy expenditure. Parent workbook. Education on different food groups, detailed product information and child‐friendly recipes. Used the Food Pyramid. Parenting skills focused on understanding of eating habits and lifestyles, cognitive and behavioural barriers to change, general parenting skills of positive involvement, monitoring, problem‐solving skills and maintaining positive changes already effected; self control and healthier lifestyle sessions (full details of content provided)

Sessions conducted by dietician and a psychologist under supervision of a behavioural therapist and a manual for each session was available

Control:

Waiting list control

Outcomes

Outcomes reported in abstract of publication: BMI, parental report of child's eating behaviour, familial health principles

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Commercial funding

Peer review publication

Stated aim for study

Quote from publication "To evaluate a parent‐led intervention for overweight children between 6 and 12 years old"

Notes

Also report a follow‐up study comparing all families post intervention with a sample of families who did not respond to the original invitation. Not relevant here

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Quote from publication: "randomly assigned on the basis of the date on which they contacted the research group"

Comment: high risk

Allocation concealment (selection bias)

High risk

Comment: assignment by a co‐worker, no other details

Blinding of participants and personnel (performance bias)
Subjective outcomes

High risk

Quote from study author: "Participants knew whether they would start immediately (intervention group); or had to wait (waitlist condition)"

Comment: no details blinding of study personnel

Blinding of participants and personnel (performance bias)
Objective outcomes

High risk

Quote from study author: "Participants knew whether they would start immediately (intervention group); or had to wait (waitlist condition)"

Comment: no details blinding of study personnel

Blinding of outcome assessment (detection bias)
Subjective outcomes

High risk

Comment: no details, as height and weight considered by reviewers as a subjective outcome as were obtained by parental report

Blinding of outcome assessment (detection bias)
Objective outcome

High risk

Quote from study author: "height and weight were obtained by parental report"

Incomplete outcome data (attrition bias)
Subjective outcomes

Unclear risk

Comment: questionnaire completion rates provided and some withdrawn by study authors as missing items

Incomplete outcome data (attrition bias)
Objective outcomes

Unclear risk

Comment: reports numbers but not reasons for drop‐out. All drop‐outs from waiting list control group so some imbalance. No description of how analysed

Selective reporting (reporting bias)

High risk

Comment: subjective outcomes not reported at baseline or follow‐up for the 2 groups separately but are reported for both combined

Other bias

Unclear risk

Comment: is reported to be a pilot study so unclear if sample size is appropriate to detect a difference

Methods

Parallel randomised controlled trial

Randomisation ratio: 1 : 1 : 1

Superiority design

Participants

Inclusion criteria: ≥ 85th percentile for BMI as determined by the Centers for Disease Control growth charts, having no dietary or physical activity restrictions

Exclusion criteria: participating parent could not read English, had a psychological disorder that would impair ability to participate or if the family was planning to move out of the area during the programme

Diagnostic criteria: BMI ≥ 85th percentile

Interventions

Number of study centres: not reported

Treatment before study: none

Titration period: none
Description of interventions

Behavioural parent‐only intervention:

8 sessions, 45 minutes each

Focused on increasing child growth monitoring and providing feedback to families

2 interventions that combined the parent‐only intervention with a 6‐month, behavioural, parent‐only intervention that focused on 2 energy‐balance (diet) behaviours:
[DECREASE]

Decreasing sugar sweetened beverage and sweet and salty snack food intake. Children and parents reduced intake of sweet and salty snack foods (i.e. candy, cookies, ice cream, chips, nuts) to ≤ 3 servings/week, and sugar sweetened beverages (i.e. soda, Kool‐aid, sweetened tea, non‐100% fruit juice, sports drinks) to ≤ 3 servings/week
[INCREASE]

Increasing fruit, vegetable and low‐fat dairy intake. Children and parents were encouraged to consume 2 servings/day of whole fruit, 3 servings/day of vegetables and 2 servings/day of low‐fat dairy products
Sessions covered behavioural lessons and emphasised monitoring of targeted behaviours, pre‐planning, problem solving, shaping, setting goals, positive reinforcement, stimulus control and parental modelling of targeted behaviours. These behavioural strategies are endorsed in both the 1997 and 2007 recommendations. Children and their parents self monitored the targeted behaviours and turned in records at each meeting

Families received USD 20 for completing each of the 6‐ and 12‐month assessments

Based on behavioural economics theory (changing a substitute behaviour of a target behaviour enhances the feeling of choice for engaging in and liking the targeted behaviour, which could increase long‐term adherence). Meetings were led by an experienced research‐staff therapist (either master or doctoral level) with expertise in nutrition or exercise science, and behaviour modification

Following the 6‐month intervention, all families received feedback on growth at 9 months, and final assessments were conducted at 12 months

Outcomes

Outcomes reported in abstract of publication: BMI z score, energy intake

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "to examine the efficacy of U.S. primary care paediatric obesity treatment recommendations, within two randomised trials"

Notes

Authors provided change data from baseline to immediate and longest follow‐up for BMI z score, following contact to request further data.

There are 2 comparisons of relevance to this review, the parent‐only vs. the decrease group and the parent‐only vs. the increase group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "Participants in each trial were randomly assigned to one of three interventions in a 1:1:1 allocation ratio. Using random permuted blocks within strata (gender), cards with intervention assignment were sealed in an envelope by research staff not engaged in intervention or assessments and provided to families at a randomisation visit, following completion of baseline assessments"

Allocation concealment (selection bias)

Low risk

Quote from publication: "Participants in each trial were randomly assigned to one of three interventions in a 1:1:1 allocation ratio. Using random permuted blocks within strata (gender), cards with intervention assignment were sealed in an envelope by research staff not engaged in intervention or assessments and provided to families at a randomisation visit, following completion of baseline assessments"

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: masking of carers and participants to allocation but unclear if blinded to intervention

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Quote from publication: "Dependent measures were collected by trained research‐staff blinded to treatment assignment"
Comment: outcome assessors masked to treatment assignment

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: ITT analysis. Missing data filled using a multiple imputation strategy. Specifically, for each participant with a missing BMI z score value, 5 random variables from a normal distribution that has a mean equal to the baseline BMI z score and variance equal to the estimated variance for BMI z score of other participants at the time where BMI z score is missing

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: not enough detail to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: 1 : 1 : 1

Superiority design

Participants

Inclusion criteria: ≥ 85th percentile for BMI as determined by the Centers for Disease Control growth charts, having no dietary or physical activity restrictions

Exclusion criteria: participating parent could not read English, had a psychological disorder that would impair ability to participate or if the family was planning to move out of the area during the programme

Diagnostic criteria: BMI ≥ 85th percentile

Interventions

Number of study centres: not reported

Treatment before study: none

Titration period: none

Description of interventions

Behavioural parent‐only intervention:

as above.

2 additional interventions were:
[TRADITIONAL]

Decreasing sugar‐sweetened beverage intake and increasing physical activity. Encouraged children to reach 60 minutes/day (parents 30 minutes/day) of moderate‐intensity physical activity most days of the week and for children and parents to consume ≤ 3 servings of sugar‐sweetened beverages/week.
[SUBSTITUTE]

Increasing low‐fat milk intake and decreasing TV watching, encouraged children and parents to watch ≤ 2 hours of TV/day and to consume 2 servings of low‐fat milk/day

Outcomes

Outcomes reported in abstract of publication: BMI z score, energy intake

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "to examine the efficacy of U.S. primary care paediatric obesity treatment recommendations, within two randomised trials"

Notes

There are 2 comparisons of relevance to this review: the parent‐only vs. the substitute group and the parent‐only vs. the increase group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "Participants in each trial were randomly assigned to one of three interventions in a 1:1:1 allocation ratio. Using random permuted blocks within strata (gender), cards with intervention assignment were sealed in an envelope by research staff not engaged in intervention or assessments and provided to families at a randomisation visit, following completion of baseline assessments"

Allocation concealment (selection bias)

Low risk

Quote from publication: "Participants in each trial were randomly assigned to one of three interventions in a 1:1:1 allocation ratio. Using random permuted blocks within strata (gender), cards with intervention assignment were sealed in an envelope by research staff not engaged in intervention or assessments and provided to families at a randomisation visit, following completion of baseline assessments..."

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: masking of carers and participants to allocation but unclear if blinded to intervention

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Quote from publication: "Dependent measures were collected by trained research‐staff blinded to treatment assignment.."
Comment: outcome assessors masked to treatment assignment

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: ITT analysis. Missing data filled using a multiple imputation strategy. Specifically, for each participant with a missing BMI z score value, 5 random variables from a normal distribution that has a mean equal to the baseline BMI z score and variance equal to the estimated variance for BMI z score of other participants at the time where BMI z score is missing

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: not enough detail to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: aged 5.0‐9.9 years, overweight (International Obesity Task Force definition) and prepubertal (Tanner stage 1), having a carer willing to attend sessions and able to speak English

Exclusion criteria: BMI z score of 4.0, having a syndromal cause of obesity, using medications that influence weight, having a physical or developmental disability, having a chronic illness or having a sibling enrolled in the study

Diagnostic criteria: overweight (International Obesity Task Force definition)

Interventions

Number of study centres: 3

Treatment before study: none

Titration period: none
Description of interventions

24‐week intervention delivered by a dietician (accredited training for the parenting skills component)

2 groups: parent healthy lifestyle group and healthy lifestyle group

The interventions included 12 (parent group) or 8 (healthy lifestyle) 90‐ to 120‐minute group sessions (open to both parents but mostly attended by mothers) and 4 telephone sessions, delivered over 6 months with tapered frequency (weekly, bimonthly, then monthly). Details of the standardised parenting skills programme and the healthy lifestyle education sessions reported (references given). The 4 telephone sessions alternated with the last 4 group sessions for both arms, using a standard protocol

Parenting healthy lifestyle:

The Positive Parenting Program (Triple P) was delivered in 4 sessions before the healthy lifestyle component. It is a standardised and evaluated generic parenting programme widely used in Australia and provides comprehensive facilitator training
Healthy lifestyle:

The 8 sessions included recommendations on specific core food servings; practical skills for healthy eating, reduced sedentary behaviours and increased activity; and monitoring of lifestyle behaviours and roles and responsibilities around eating, managing appetite, self esteem and teasing. Children and siblings participated in fun, non‐competitive activity sessions run by physical activity educators. These sessions provided optional active child care for participants in both groups and were not part of the intervention

Outcomes

Outcomes reported in abstract of publication: BMI z score, waist z score

Study details

Run‐in period: no clear run‐in period

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "... to evaluate (1) the effectiveness of a healthy lifestyle intervention for overweight children aged 5 to 9 years that targets parents as the agents of change and (2) whether additional specific parenting skills training would improve parenting skills and enhance the intervention effect. The long‐term effect (2 years from baseline) and the immediate postintervention effect (at completion of the intervention, 6 months from baseline) were assessed. We also aimed to confirm gender differences reported in our previous study..."

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: ".. After baseline measurements, participants were allocated to intervention groups using computer‐generated randomisation schedules stratified according to gender and recruitment site and prepared by staff not otherwise involved in the study"

Allocation concealment (selection bias)

Low risk

Quote from publication: "Allocation was concealed in opaque, sequentially numbered, sealed envelopes and opened by parents after completion of baseline measurements..."

Blinding of participants and personnel (performance bias)
Subjective outcomes

High risk

Comment: a single‐blinded randomised controlled trial blind at point of allocation, but not blinded to which intervention they received

Blinding of participants and personnel (performance bias)
Objective outcomes

High risk

Comment: a single‐blinded randomised controlled trial blind at point of allocation, but not blinded to which intervention they received

Blinding of outcome assessment (detection bias)
Subjective outcomes

Low risk

Comment: those who took measurements were blinded to type of intervention

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Comment: those who took measurements were blinded to type of intervention

Incomplete outcome data (attrition bias)
Subjective outcomes

High risk

Comment: stated ITT was conducted using all available data according to allocation, regardless of attendance (details provided). However, a second per‐protocol analysis was performed that included only those who attended ≥ 75% of the programme sessions. The potential effect of missing data were explored using T tests to compare the baseline and 6‐month BMI z scores of those who remained and those who were lost to follow‐up. No reasons for drop‐outs were given. It is unclear whether data presented were ITT or not

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: stated ITT was conducted using all available data according to allocation, regardless of attendance (details provided). However, a second per‐protocol analysis was performed that included only those who attended ≥ 75% of the programme sessions. The potential effect of missing data were explored using T tests to compare the baseline and 6‐month BMI z scores of those who remained and those who were lost to follow‐up. No reasons for drop‐outs were given. It is unclear whether data presented were ITT or not

Selective reporting (reporting bias)

High risk

Comment: states health‐related quality of life measured but no data reported

Other bias

Unclear risk

Comment: no true control group. Parenting outcomes only given for the whole sample, not split into intervention and control groups ‐ therefore success of intervention in each group cannot be compared. Retention rates moderate for the long follow‐up period. Unclear if ITT analysis was performed. Likely the participants who dropped out the study were more overweight

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: parents participated in the treatment voluntarily. Children's percentage of overweight had to be at least 130%

Exclusion criteria: none stated

Diagnostic criteria: overweight (as above)

Interventions

Number of study centres: 3

Treatment before study: none

Titration period: none

Description of interventions:

Parental CBT:

'Finger in the pie' was a cognitive behavioural treatment and each session addressed a different theme associated with childhood overweight. The purpose was not purely to present information, but to teach parents to think of alternatives and possible solutions themselves. This way, future coping abilities were addressed. The following themes were included: creating realistic expectations concerning the development of their children's weight status, modifying eating and exercising habits, knowledge on how parents can influence the behaviour of their children (e.g. by modelling and by the use of control and rewards), information on the development of overweight, handling feelings of guilt, and recognising and handling a child with low self esteem. So, instead of purely focusing on nutrition and physical activity, a substantial part of the treatment was devoted to enhancing parenting tactics (e.g. teaching parents to ignore undesirable behaviours and to reward desirable behaviours). This aspect of the treatment combined with extensively discussing parental control makes the current intervention distinguishing
Of the 2‐hour sessions, the first hour was interactive. 1 of the main goals of this first hour was to identify wrong thought patterns and challenging these patterns. The second hour of each session was more informative and practical by nature

Behavioural and nutritional components
Session 1 ‐ the part that parents play; session 2 ‐ eating behaviour; session 3 ‐ physical exercise; session 4 ‐ parental control; session 5 ‐ be in good spirit; session 6 ‐ food and party; session 7 ‐ relapse; session 8 ‐ responsibility

Intervention carried out according to a protocol, written by the first and the second authors and carried out by trained cognitive behavioural therapists

Waiting list control:

Offered the treatment after 6 months

Outcomes

Outcomes reported in abstract of publication: BMI percentile, relapse, psychopathology, self esteem and negative thoughts

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Funding not stated

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "The aim of the current study is to investigate whether a treatment that aims at parents exclusively (by targeting eating and exercise behaviours, and supporting self‐esteem of the child in a cognitive‐behavioural manner) would be successful in reducing their children's overweight. Such a treatment might lead to better results than treatments focusing on children, as parents play an important role in their children's eating and exercising behaviours, and in promoting their self‐esteem..."

Notes

Randomisation was broken because 9 participant families from the waiting list control were included in the intervention arm, the study did not report the numbers randomised to each group, just the total numbers randomised, the group sizes were unbalanced (59 vs. 39), and the paper states that 9 were 'included in the treatment group'

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote from publication: "Parents were randomly assigned to either the treatment group or the waiting‐list control group"

Comment: no description of randomisation process

Allocation concealment (selection bias)

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Subjective outcomes

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Subjective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Subjective outcomes

Low risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: ITT analysis. The missing values at the follow‐up meeting were replaced by the last‐observation‐carried‐forward. The missing in‐between values (post‐treatment) were replaced by the mean of the values before treatment and at 3‐month follow‐up. Numbers of drop‐outs reported

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

High risk

Comment: as only 9 of the 48 families in the waiting‐list control group eventually decided to participate in the treatment after the waiting period, it was decided to include these 9 families in the treatment group, and to disregard their data from the waiting period. These 9 families did not differ from the original treatment group or the control group

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: overweight or obese (defined according to age‐ and sex‐specific international BMI cut‐off points (reference provided); aged 5‐9 years; pre‐pubertal (no pubic hair ‐ Tanner stage 1); generally healthy

Exclusion criteria: extreme obesity (BMI z score > 4); known syndromal cause of obesity; long‐term steroid use; medications associated with weight gain; chronic illness; significant dietary restrictions

Diagnostic criteria: overweight or obese (defined according to age‐ and sex‐specific international BMI cut‐off points

Interventions

Number of study centres: not reported

Treatment before study: not reported

Titration period: not reported
Detailed description of all interventions

Parent DIET Intervention:

Aimed at parents, not children. Informs parents of how to improve their child's diet. Based on the "Health Belief Model" (reference provided).
10 parent focused face‐to‐face group sessions ‐ each 2 hours long. 3 monthly telephone calls for the first 3 months of the intervention. Goal setting, problem‐solving, role‐modelling and positive reinforcement are used to manage changes in food behaviours and strategies incorporated to help parents increase their confidence in making changes related to their goals. The structure and content of the programme uses a cognitive behavioural, solution‐focused approach from the emerging field of health coaching. Behavioural change targeted during the sessions to reduce total energy and fat intakes, increase fruit and vegetable intake and make healthy beverage and snack choices. Practical advice about food shopping and preparation is provided with the sessions including a didactic component, group work and practical activities

Delivered by a dietician

Parent and child physical activity (child was main focus):

Parent encouraged to set realistic short‐ to medium‐term SMART goals for increasing physical activity and reducing sedentary behaviours. Asked to identify barriers in their family lives that may prevent their child from participating in sufficient physical activity or that leads to their child spending excessive amounts of time in small screen recreation

Children attended 10 x 2‐hour face‐to‐face weekly sessions. Each week children participate in a variety of activities aimed at improving their mastery of 12 fundamental movement skills (run, jump, leap, hop, slide, gallop, strike, roll, kick, throw, catch, bounce). Each session covered 3 fundamental movement skills, such that over the course of the 10 weeks each skill is re‐visited, although the focus is on more complex components of the skill, in subsequent sessions. Skill mastery is aided by adherence to lesson plans for each skill incorporating several learning stages:

• contextual stage (questions children as to what games, sports and activities require mastery of the specific skill and how the skill is performed proficiently);

• exploration stage (allows children to explore the different movement patterns related to the skill using movement concepts such as force, speed, levels and relationships);

• guided discovery stage (isolates specific components of a skill and using a problem solving approach, guides children to discover the correct way to perform the skill);

• skill application stage (applies the skills in small drill activities and modified game contexts)."

1 Refresher session (2 hours) attended at week 18; 3 monthly telephone calls at weeks 14, 18 and 22 of the invention

To maximise the children's competence and confidence, they were strongly encouraged to practice the fundamental movement skills at home with their parents or siblings (or both), between each group session. Each participant given a 'Home‐challenge folder', which included fun, relevant and developmentally appropriate activities enabling practice of skills at home. The home challenges took approximately 30 minutes and children were encouraged to complete 3 sessions each week

Based on the "Competence Motivation Theory" (reference provided). Delivered by physical education teachers
Parent‐Child Physical Activity + DIET:

Same components as the DIET and physical activity interventions. 25 sessions. Delivered by physical education teachers and dieticians.
10 Parent‐focused face‐to‐face group sessions ‐ each were 2 hours long (10 weeks); 10 child‐focused face‐to‐face group sessions ‐ each 2 hours long (10 weeks); 1 refresher session (2 hours) attended at week 18; 3 monthly telephone calls at weeks 14, 18 and 22 of the invention; 1 parent workshop ‐ 1 hour long

Outcomes

Outcomes reported in abstract of publication: BMI z score, waist measurements, metabolic outcomes

Study details

Run‐in period: not reported

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "Outcomes of childhood obesity interventions are rarely reported beyond 1 year. We hypothesized that the impact on the BMI z score from a child‐centred physical‐activity program in combination with a parent‐entered dietary‐modification program would be greater than either program conducted alone at 24 months' after baseline"

Notes

There were 2 comparisons of relevance to this review: the parent‐only vs. parent‐child physical activity group and the parent‐only vs. the parent‐child physical activity and diet group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "To randomly allocate participants to one of the three intervention groups the bias coin method of allocation, using a computer‐based random number‐producing algorithm, is used. This method ensures an equal chance of allocation to each group. Stratification by gender and site is done to ensure an equal representation in groups at each site. Only one study member at each site has access to the allocation codes and these are stored on a password‐protected computer"

Allocation concealment (selection bias)

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Subjective outcomes

High risk

Comment: no blinding

Blinding of participants and personnel (performance bias)
Objective outcomes

High risk

Comment: no blinding

Blinding of outcome assessment (detection bias)
Subjective outcomes

Low risk

Quote from publication: "Outcome measures were assessed at baseline and 6, 12, and 24 months by trained assessors blinded to group assignment..."

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Comment: "Outcome measures were assessed at baseline and 6, 12, and 24 months by trained assessors blinded to group assignment..."

Incomplete outcome data (attrition bias)
Subjective outcomes

High risk

Comment: ITT performed, however, high numbers not completing (35% to 51% completers after 2 years)

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: ITT performed, however, high numbers not completing (35% to 51% completers after 2 years)

Selective reporting (reporting bias)

High risk

Comment: only the 24‐month results are shown

Other bias

Unclear risk

Comment: not enough information to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Non‐inferiority design: 1‐sided confidence interval

Participants

Inclusion criteria: parents and their overweight or obese (> 85th BMI percentile) children, aged 8‐12 years. At least 1 parent or guardian participated with the child. If 2 children in the family met criteria for the study, both were invited to attend the treatment groups but a coin‐flip was used to determine which child's data would be part of the study

Exclusion criteria: either the child or parent currently involved in psychological or weight loss treatment, using medications that affected weight or appetite, or had a psychiatric or physical condition (e.g. eating disorder, psychosis) that would interfere with participation

Diagnostic criteria: as above (> 85th BMI percentile)

Interventions

Number of study centres: 2

Treatment before study: none

Titration period: none
Intervention description:

Parent‐only:

Behavioural change skills; included self monitoring of targeted behaviours, positive reinforcement, stimulus control, pre‐planning and modelling. Parents in the parent‐only group were coached on how to assist their children in weight monitoring at home and reflect on the behaviours that influenced weight. Goal setting for the parent‐only group occurred during the treatment groups. Completed quizzes each week to assure knowledge of the treatment protocol. The intervention was theoretically based: using a current state‐of‐the‐art behavioural treatment for childhood obesity described by Epstein and colleagues (references provided)

All interventionists attended a 3‐day training regarding the behavioural intervention for the study, and were supervised by the first author on a weekly basis during treatment. The intervention was provided by a psychologist

Parent‐child intervention:
The material taught in the child groups was similar in content to that taught to the parents and described above, but presented in an age‐appropriate manner (i.e. fun games). Parent‐child dyads also met with an interventionist either pre‐ or post group for family goal setting for a maximum of 10 minutes. All parents and children completed quizzes each week to assure knowledge of the treatment protocol.

Components of the interventions in common between the groups included:

• 20‐week intervention, number of sessions not reported, each session was 60 minutes

• A physical activity component: energy expenditure was addressed by increasing physical activity (lifestyle and planned) and decreasing sedentary behaviour

• A nutritional advice component (traffic‐light diet): following the food guide pyramid and focusing on decreasing energy intake while increasing the nutrient density of the diet

• No medication component was included

• No financial incentives

Outcomes

Outcomes reported in abstract of publication: inferiority of treatment group on child weight loss, parent weight loss and child physical activity, caloric intake

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "to evaluate whether a standardized behavioral parent only treatment program would not be inferior to a standardized behavioral parent‐child program on child weight loss and other relevant markers of change"

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: 80 parent‐child dyads were randomly assigned to either parent‐child or parent‐only groups. Random assignment was conducted after completing the initial assessment using a computer‐generated random numbers table

Allocation concealment (selection bias)

Unclear risk

Comment: no further details

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: ITT analysis but data not presented. A multiple imputation approach was used as a form of sensitivity analysis, which yielded non‐substantive differences with full‐likelihood approach to analysing the data that are reported. Parent‐only: 24/40 pairs completed follow‐up. Parent‐child: 28/40 pairs completed follow‐up. No further details

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: not enough information to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: parent described the child's body size as overweight, the child was 4‐11 years of age, and the parent agreed to attend a 12‐week intervention

Exclusion criteria: child taking medication that affected growth or weight control, or had a severe developmental delay or disability

Diagnostic criteria: parental description of child as overweight

Interventions

Number of study centres: 6

Treatment before study: none

Titration period: none
Description of the intervention:

Parent‐only:

12‐week intervention, 1 session per week. Group Lifestyle Triple P is a modification of Level 4 Group Triple P tailored to the concerns of parents of overweight and obese children. The intervention is a 12‐week intervention that consists of 9 x 90‐minute group sessions and 3 x 20‐minute telephone sessions. To help parents acquire new knowledge and skills, all sessions used an active skills training process (e.g. demonstrating and rehearsing skills) within a self regulation framework (e.g. self selecting goals and self evaluating progress). Each parent received a workbook summarising the session content, and suggested between‐session tasks
Group sessions: in the first group session, motivational interviewing techniques were used to enhance parents' commitment to change. During subsequent group sessions, a range of specific strategies were introduced and practised. These included: positive parenting strategies (e.g. keeping track of children's lifestyle behaviour, setting clear guidelines about food and activity, reinforcing healthy behaviour). Also physical activity strategies (e.g. reducing TV and computer time, increasing energetic play, encouraging involvement in sport) and nutrition strategies (e.g. establishing eating routines, modifying recipes, reading food labels) were introduced and practised
Telephone sessions: during the telephone sessions, the facilitator reviewed parents' implementation of strategies, and problem‐solved any difficulties. The final group session covered progress review and maintenance of treatment gains

Triple P programme was standardised. All sessions were facilitated by a clinical psychologist and accredited provider of Group Triple P (who co‐authored the intervention materials), with assistance from graduate students in nutrition and dietetics, physical education and psychology

Control:

Waiting list control for 12 weeks. Included a physical activity and nutritional advice components

Outcomes

Outcomes reported in abstract of publication: child BMI z score and weight‐related problem behaviour, confidence in managing children's weight‐related behaviour

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "..to evaluate the effects of the intervention on parenting and child weight‐related behaviour, relative to a waiting list control condition. This study describes the evaluation of a lifestyle‐specific parenting program (Group Lifestyle Triple P) on multiple child and parent outcomes..."

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "Families were randomly allocated to either the intervention...or the waiting list control...Groups were allocated to conditions according to a list of computer generated random numbers..."

Allocation concealment (selection bias)

High risk

Quote from publication: "Allocation concealment and blinded outcome assessment were not possible due to limited staff and resources"

Comment: no masking of allocation to intervention or control

Blinding of participants and personnel (performance bias)
Subjective outcomes

High risk

Comment: no masking

Blinding of participants and personnel (performance bias)
Objective outcomes

High risk

Comment: no masking

Blinding of outcome assessment (detection bias)
Subjective outcomes

High risk

Comment: no masking

Blinding of outcome assessment (detection bias)
Objective outcome

High risk

Comment: no masking

Incomplete outcome data (attrition bias)
Subjective outcomes

Low risk

Comment: numbers missing reported and reasons explained; ITT analysis with the last point‐carried‐forward

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: numbers missing reported and reasons explained; ITT analysis with the last point‐carried‐forward

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: not enough information to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: eligible parents must have had a child: (a) with a BMI ≥ 85th percentile, (b) enrolled at 1 of the 2 study schools, (c) between Grades K and 5, (d) parents also had to agree to be randomised to either 1 of the 2 study conditions. In instances when families had multiple children enrolled at a study school with BMIs ≥ 85th percentile, the oldest child was considered the index child

Exclusion criteria: none stated

Diagnostic criteria: 85th percentile BMI

Interventions

Number of study centres: 2

Treatment before study: none

Titration period: none
Description of interventions:

Focus groups with 9 parents helped to determine study content, messages, and potential use of the 2 delivery methods, 1‐to‐1 counselling and mailed materials

Educational mailed materials:

Posted approximately every 5 weeks, 6 mailings over 30 weeks

The educational material included: tips to increase walking, talk with children about TV viewing. Received a physical activity book and a pedometer. Read nutrition labels, shop more healthfully at grocery stores, talk with children about eat out healthfully. Received a cookbook, had a hands‐on activity about portion sizes

Educational material plus personal encounters:
Received the same educational materials as above

The type of encounter (home visit, telephone call, etc.) was based on participating parents' preferences and schedules. Parents selected the topics discussed during each visit from choices provided by community health workers (CHWs) (i.e. epidemiology of childhood overweight, biological, social and environmental influences on childhood overweight; basic nutrition; label reading; grocery shopping strategies, including a tour of a local grocery store; physical activity guidelines)

Mean 3.4 personal encounters over the 30 weeks. On average, parents received encounters for 18 weeks

Both interventions were delivered by CHWs who attended a 36‐hour training programme over the course of 6 days. The purpose of the training was to prepare CHWs to make evidence‐based recommendations to families such as changing to reduced fat milk, reducing the intake of snack foods, replacing sugar‐sweetened beverages with water, increasing fruit and vegetable intake, decreasing TV viewing and increasing physical activity. The topics covered during the training included guidelines for home visits; the epidemiology of childhood overweight, biological, social and environmental influences on childhood overweight; basic nutrition; label reading; grocery shopping strategies, including a tour of a local grocery store; physical activity guidelines and counselling strategies. CHWs practiced counselling skills during their training by engaging in role‐plays with each other. After training and throughout the study, the study staff and CHWs met monthly to discuss specific concerns or difficulties with study participants

Outcomes

Outcomes reported in abstract of publication: BMI

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "The goal was to create an easy‐to‐use parent outreach model that could ultimately be used by school nurses, paediatricians, community health agencies, and CHWs"

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote from publication: "Parents from two schools were randomly selected to participate in one of two study groups and were randomised to either one of the two study conditions..."

Comment: no description of randomisation process

Allocation concealment (selection bias)

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: no ITT analysis. In all, 42/46 (91%) parents completed post‐intervention surveys

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: not enough detail to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: BMI ≥ 85th percentile for their age

Exclusion criteria: plans to move out of the state during the course of the study, a request by the child's paediatrician that the family not be contacted

Diagnostic criteria: BMI ≥ 85th percentile for their age

Interventions

Number of study centres: not reported

Treatment before study: not reported

Titration period: not reported
Description of interventions:

Based on social‐ecological theory (reference provided). 3 intervention groups: workbook, group sessions, group sessions + interactive voice response (IVR) counselling

Parent group + IVR counselling:

Group sessions as above. Then 10 follow‐up sessions by IVR, 1 per week. Included behavioural, physical activity and nutritional components (12‐week intervention)

Physical activity get at least 2.5 hours of moderate physical activity this week; make a list of your family's barriers to physical activity around the house, and come up with a way to overcome them; do something active with your child for 15 minutes at least 3 times this week; review the family goal sheet with your family and set measurable, specific and objective goals this week; decrease your sitting time by 0.5 hours each day this week; increase your physical activity by 1 day per week; set a goal to take your family to a new park or trail that you have not visited before; survey your family regarding physical activity that they would like to do as a family, and try to do that activity at least 3 times per week

Nutrition parent healthy habits: set a good example for your child by eating 5‐9 servings of fruits and vegetables every day this week; drink low‐fat milk at 1 meal each day; clear the kitchen cupboards of unhealthy snacks; prepare at least 1 healthy meal together with your child; post signs at least twice this week about your family's positive changes with healthy eating; decrease your soda and sugared‐drink consumption by 1 serving per day; increase your servings of fruits and vegetables by 3 per day; check your library for cookbooks, recipes or videos that help your family to prepare nutritious meals; change 1 food item that is high‐fat to a healthy snack of fruit or vegetable

Behavioural consistency and contingency; communication; praise; parenting skills; support; plan; commitment

Group sessions were led by a dietician (no further details)

Parent group sessions:

2 group sessions. Utilised the workbook used in the control condition. Addressed parents' behavioural health skills and knowledge of weight, nutrition and physical activity. It also identified key parenting skills: limit setting, effective communication and role modelling. This session concluded with role playing, problem solving and the development of an action plan. 24‐week intervention

Parent workbook group:

61‐page workbook to promote physical activity and the consumption of fruits and vegetables and decrease sugared‐drink consumption and TV viewing/recreational computer time. Activity to explore parental beliefs about eating and physical activity, healthy habits for creating a healthy family, defining the division of responsibility for eating and activity. Physical activity: using FITT (frequency, intensity, time, type) principles. Nutrition: helping children to avoid fad diets, reading labels, selecting healthy food options, sample menus, tips for preparing healthy snacks and meals. Assessing and calculating BMI in children and adults, causes of overweight in children (biological, cognitive, environmental), 5 reasons children gain weight, impact of being overweight, parenting skills to support weight reduction, survey of the family home environment, ways to promote a healthy home environment, goal setting: creating a family action plan, process of goal setting and keeping objectives clear, parent's personal action plan, barriers and strategies to maintaining family action plan. 24‐week intervention

Outcomes

Outcomes reported in abstract of publication: child BMI z scores, symptoms of eating disorders and body image

Study details

Run‐in period: not reported

Study terminated before regular end (for benefit/because of adverse events): not reported

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "A practical RCT [randomised controlled trial] evaluated the relative effectiveness of three interventions to support parents of overweight or at‐risk children to change the home environment to foster more healthful child eating and activity behaviours, thereby reducing child BMI and BMI z scores. A secondary purpose was to determine the patterns of use and potential dose effect for the highest‐intensity intervention"

Notes

There were 3 comparisons of relevance to this review: the parent‐only group and IVR vs. the control (workbook); the parent‐only group vs. the control; the parent‐only group and IVR vs. the parent group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "Through a random‐numbers table, participants were assigned randomly (families/staff unblinded) to the FC‐workbook, the FC‐group, or the FC‐IVR intervention..."

Allocation concealment (selection bias)

Unclear risk

Comment: no details

Blinding of participants and personnel (performance bias)
Subjective outcomes

High risk

Comment: families/staff were both unblinded

Blinding of participants and personnel (performance bias)
Objective outcomes

High risk

Comment: families/staff were both unblinded

Blinding of outcome assessment (detection bias)
Subjective outcomes

High risk

Comment: families/staff were both unblinded

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Comment: families/staff were both unblinded, but probably no substantial impact on outcome measures

Incomplete outcome data (attrition bias)
Subjective outcomes

Low risk

Comment: study says they carried out ITT analysis; however, results were only given for completers. 72% in workbook intervention, 66% in group intervention and 74% in group + IVR intervention completed 12‐month follow‐up ‐ drop‐outs rates average for this length of follow‐up

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: study says they carried out ITT analysis; however, results were only given for completers. 72% in workbook intervention, 66% in group intervention and 74% in group + IVR intervention completed 12‐month follow‐up ‐ drop‐out rates average for this length of follow‐up

Selective reporting (reporting bias)

High risk

Comment: states health‐related quality of life reported but no data reported

Other bias

Unclear risk

Comment: unsure if all the participants stayed in their randomised groups

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Equivalence design

Participants

Inclusion criteria: BMI > 85th percentile adjusted for gender and age. Participating family members were able to speak and write in German. All participants were free from diabetes, heart disease and endocrine disorders

Exclusion criteria: parents and children meeting the criteria of the DSMIV‐TR for mental disorders warranting immediate treatment (assessed in a clinical interview), such as suicidal tendency, psychosis, mania, organic dementia or substance abuse disorder. Parents' or children's participation in a diet programme or other psychotherapy treatment with weight loss medication. There were only 4 fathers eligible for treatment, therefore, excluded from the analyses

Diagnostic criteria: BMI > 85th percentile adjusted for gender and age

Interventions

Number of study centres: 2

Treatment before study: none

Titration period: no
Description of interventions: the TAKE (Training adipöser Kinder und ihrer Eltern) programme. Programme overall proceeded with group sessions that began with a short overview of the topic, then individual difficulties and progress with homework were discussed and the group established coping strategies. Afterwards the major topics of the sessions were implemented and new homework was assigned. Interventions throughout the programme were highly interactive, proceeded step by step, and involved the group as a whole as well as individual mothers and children (where appropriate)

Mother's CBT:

10 sessions in 5 phases over 10 weeks (120‐minute sessions)

Phase 1 (nutrition and eating behaviour, covered across 8 sessions including psychoeducation about childhood obesity, risks, nutritional counselling, goal setting, stimulus control, family rules); phase 2 (physical activity, covered within 2 sessions including psychoeducation about physical activity, motivation, suitable sports); phase 3 (social competences, covered in 1 session, including social skills training, parental modelling and support of children dealing with difficulty situations); phase 4 (body concept, covered in 1 session, included supporting child's developments of a positive body concept); phase 5 (relapse prevention, covered in 1 session, included training of maintenance skills, appraisal of goal attainment, developing coping strategies). Children attended a relaxation training (progressive muscle relaxation training) of equal frequency and duration to the disorder‐specific CBT of children in the mother‐child group
Mother‐child arm:

10 weekly treatment sessions of 120 minutes. Mothers received CBT including the same components as the Mothers‐only group. Children received sessions on nutrition and eating behaviour, basic nutritional education, reinforcement and tokens, lessons in physical activity, social competencies (self assertiveness, social skills, saying 'no' to food offers, role modelling, anti‐bullying plans), developing a positive body concept and relapse prevention

Sessions were undertaken by psychologists and trained co‐therapists. All therapists were trained and supervised weekly by 1 of the authors

Outcomes

Outcomes reported in abstract of publication: per cent overweight, general behaviour problems (externalising and internalising behaviour problems), global and social anxiety, and depression

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal and Word document

Stated aim for study

Quote from publication: "we investigated whether the treatment of parents only would be as efficacious as a parent‐child treatment in a randomised controlled clinical trial. Our group treatment approach, TAKE [Training adipöser Kinder und deren Eltern ('training of obese children and their parents')], targeted weight stabilization and reduction of behavioral problems of obese children aged 8‐12 years"

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote from publication: "families were randomly assigned according to a permuted block design to either the mother‐child (condition A) or the mother‐only (condition B) cognitive behavioral therapy (CBT) treatment..."

Allocation concealment (selection bias)

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Subjective outcomes

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Subjective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details provided

Incomplete outcome data (attrition bias)
Subjective outcomes

High risk

Comment: high rates of drop‐out (mother‐child 11/31 dropped out, in mother‐only 18/25 dropped out), no ITT analysis

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: high rates of drop‐out (mother‐child 11/31 dropped out, in mother‐only 18/25 dropped out), no ITT analysis

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: families were randomly assigned according to a permuted block design to either the mother‐child (condition A) or the mother‐only (condition B) CBT treatment. Selection bias: there were only 4 fathers eligible for treatment and they were excluded from the analyses. Also underpowered

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: BMI ≥ 85th percentile for age and gender, required to live within the same dwelling in a rural county that is designated in whole or in part as a "Health Professional Shortage Areas" by the U.S. Department of Health and Human Services, to obtain physician approval to participate in the study, with documentation provided via letter signed by a physician medically clearing individuals to participate in a weight management programme

Exclusion criteria: child or participating parent has a dietary or exercise restriction, or a medical condition that contraindicates mild energy restriction or moderate physical activity (including a history of musculoskeletal condition that limits walking; heart condition; chronic lung diseases limiting physical activity; uncontrolled diabetes; uncontrolled hypertension; thyroid disease; or uncontrolled exercise‐induced asthma as determined by a physician). Children or participating parents on antipsychotic agents, systemic corticosteroids or who were currently using prescription weight‐loss drugs, insulin or other diabetic medications. Not engaged in another weight control programme, exhibit conditions or behaviours that were likely to affect their participation in the trial, such as being unwilling or unable to give informed consent, parent(s) or legal guardian(s) unable to read English at approximately the 5th grade level, unwilling to accept random assignment, unable to travel to extension office for intervention sessions, or likely to move out of the county within the next 12 months

Diagnostic criteria: BMI ≥ 85th percentile for age and gender

Interventions

Number of study centres: not reported

Treatment before study: none

Titration period: none

Detailed description of interventions

Behavioural parent‐based intervention:

12 sessions of 90 minutes
Only the participating parent(s) attended group meetings. The primary treatment objectives were to build healthier dietary habits, increase moderate intensity physical activity, establish a healthier weight status and build positive self worth
Each session included 3 segments, similar to the parent group for the Family‐Based intervention. An emphasis was placed on teaching parents how to work with their children to set goals. Each week interventionists suggested a range of dietary and physical activity targets that would be appropriate for each child and parent. Parents were encouraged to meet with their children to set individual goals within the suggested range
Increased physical activity encouraged through a pedometer‐based step programme as described above

Changes in dietary habits were addressed via a modified version of the Stoplight Diet
Set daily dietary goals at the end of each group session, which included limiting the consumption of high‐fat/high‐sugar foods (i.e. "red foods") and increasing fruit and vegetable intake. Encouraged to eat a well‐balanced diet based on the food guide pyramid

Parents participated in role‐play activities to practice negotiation of goals with their child. As children were not attending group sessions, an emphasis was placed on teaching parents how to work with their children to set goals together. Parents encouraged to utilise praise, incentives and modelling to encourage participation and goal achievement. Parents provided handouts to guide them in discussing programme material and setting weekly goals with their children. Parents weighed every other group session to monitor their weight status

Delivered as described below

Behavioural family‐based intervention:

12 sessions of 90 minutes. Parent‐child dyads participated in simultaneous but separate groups. The primary objectives were to build healthier dietary habits, increase moderate intensity physical activity, establish a healthier weight status and build positive self worth
1) In the parent group: the first portion of the meeting involved a review of the progress made in implementing the strategies developed for changing their eating and exercise habits. Difficulties reported by the parents were addressed through group support and discussion. The second segment focused on knowledge and skill training related to nutrition, physical activity and behaviour management strategies
At the end of each session, children and parents were brought together to develop goals for the week and specific plans to achieve these goals
2) The child group sessions included 3 segments: a review of progress during the previous week, a physical activity to demonstrate strategies to keep active and preparation of a healthy snack

Increased physical activity encouraged through a pedometer‐based step programme. Children and parents encouraged to monitor their physical activity and gradually increase their steps per day. Programme goals based on their baseline level of steps and targeting an increase of at least 3000 steps per day by the end of the programme. Goals set for gradually decreasing sedentary activities (children spend no more than 2 hours per day watching TV or playing video games). If excessive TV viewing was not a concern for a given family, group leaders targeted non‐homework‐based computer time
Changes in dietary habits addressed via a modified version of the Stop‐Light programme. Child and parent participants monitored everything they ate using a daily habit log. Goals were individualised to the needs of each family and based on each individual's baseline dietary intake and progress (i.e. goal attainment, weight change) over the course of the programme. Daily dietary goals set each week, including limiting the consumption of high‐fat/high‐sugar "red foods" (with an absolute minimum goal of 2 red foods per day), and increasing fruit and vegetable intake. Children and adults encouraged to eat a well‐balanced diet based on the food guide pyramid

Incentivised by providing payment for transportation costs (USD 5 per session) and USD 50 for completing post‐treatment and 6‐month assessment visits

Delivered by Family and Consumer Sciences Agents, in collaboration with a post‐doctoral clinical psychologist and graduate students in clinical health psychology who had extensive training and certification in the treatment protocols. The principal investigator of the study conducted periodic direct observation of group sessions to monitor interventionist's performance and assess treatment fidelity. The interventionists also participated in weekly supervision meetings to review each family's progress, discuss group interactions and prepare for the next group session

Waiting list control:
Families assigned to the waiting list control condition completed the assessment protocol at baseline, and at 4 and 10 months. After the follow‐up period (month 10), families were invited to participate in a 12‐session behavioural‐based intervention. No treatment was delivered until after the final, 6‐month follow‐up assessment

Outcomes

Outcomes reported in abstract of publication: BMI z score, self esteem, cost

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "The goals of the study are to (a) assess the feasibility of recruitment in rural settings, (b) develop and evaluate training protocol for group leaders, (c) determine strategies to increase adherence to monitoring and goal setting protocol, (d) evaluate strategies for participant retention, (e) assess the relative cost‐effectiveness of the interventions, (f) assess the acceptability of the intervention to families and Cooperative Extension administrators and personnel, and (g) if successful, estimate the sample size needed for a full scale trial"

Notes

There were 2 comparisons of relevance to this review: the parent‐only vs. parent‐child group and the parent‐only vs. the waiting list control group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Comment: during the initial telephone screen, families were informed as to which 2 evenings the group intervention sessions would be held in their county. Families then indicated which of these evenings they were available to attend. Before the baseline assessment, all families were randomised via computer assignment, based on availability, to 1 of the 2 specific week nights or the waiting list control condition. After randomisation of all families, the interventions (parent‐only or family based) were assigned randomly to the specific week nights

Allocation concealment (selection bias)

Unclear risk

Quote from study author: "Randomization was conducted by a research team member who did not participate in assessments. Assignments were written down and put in an envelope by the person making the assignments for each dyad. Envelope was opened with family at end of baseline visit"

Comment: unclear whether envelopes were opaque

Blinding of participants and personnel (performance bias)
Subjective outcomes

High risk

Quote from study author: "Participants and treatment personnel were not blind"

Comment: families were notified of their group assignment at pre‐treatment assessment

Blinding of participants and personnel (performance bias)
Objective outcomes

High risk

Quote from study author: "Participants and treatment personnel were not blind"

Comment: families were notified of their group assignment at pre‐treatment assessment

Blinding of outcome assessment (detection bias)
Subjective outcomes

Unclear risk

Quote from study author: "Outcome assessors were blinded in that we used personnel to complete outcome assessments that did not serve as treatment personnel in each respective county"

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Quote from study author: "Outcome assessors were blinded in that we used personnel to complete outcome assessments that did not serve as treatment personnel in each respective county"

Incomplete outcome data (attrition bias)
Subjective outcomes

High risk

Comment: no ITT analysis. Numbers completing assessment provided only

Incomplete outcome data (attrition bias)
Objective outcomes

High risk

Comment: no ITT analysis. Numbers completing assessment provided only

Selective reporting (reporting bias)

High risk

Comment: collected other measures that were not reported

Other bias

Unclear risk

Comment: not enough information to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: overweight (according to the International Obesity Task Force definition), and Tanner stage with a carer willing to attend sessions and able to read and understand English

Exclusion criteria: BMI z score > 3.5, diagnosed with a syndromal cause of obesity, using medications that influence weight gain or loss, a diagnosis of physical or developmental disability or chronic illness, and a sibling enrolled in the study

Diagnostic criteria: overweight (defined as above)

Interventions

Number of study centres: 2

Treatment before study: none

Titration period: none
Detailed description of interventions:

Parenting‐skills training:

11 sessions over 24 weeks, 4 weekly 2‐hour group sessions followed by 4 weekly, then 3 monthly 15‐ to 20‐minute individual telephone sessions. Parenting‐skills training was used to facilitate and support parents to undertake family lifestyle change. Positive, Parenting Program (Triple P) based on child development theory and social learning principles and aimed to promote parental competence to manage their child's behaviour. Standard Triple P resource materials were used with programme examples adapted to reflect dietary and activity behaviours. Application of Triple P to eating and activity behaviours was supported by provision of a general healthy lifestyle pamphlet

The Triple P Selected Seminar Series consisted of 3 x 2‐hour seminars covering: 1. positive parenting; 2. raising confident and competent‐children, and; 3. raising resilient‐children

Learning outcomes ‐ to practitioners (which some is applicable to parents)

• Core principles of positive parenting and behaviour change

• Specific positive parenting strategies for promoting children's development

• Responding to parents' questions

• Early detection and effective management of child behaviour problems

• Core principles of positive parenting and behaviour change

• Factors influencing child behaviour

• Specific positive parenting strategies for promoting children's development

• Effective parent consultation

• Identification of indicators suggesting more intervention is required and appropriate referral procedures

Triple P Discussion Groups topics are:

• hassle‐free shopping with children

• managing fighting and aggression

• developing good bedtime routines

• dealing with disobedience

Intervention delivered using standard protocols and a single, trained facilitator to limit site bias and enhance internal study validity. Sessions taken by a dietician

Parenting‐skills training with intensive lifestyle education:
As above in addition to: 7 intensive lifestyle support group sessions that focused on lifestyle knowledge and skills including the following: family‐focused healthy eating with specific core food serve recommendations, monitoring, label reading, snacks, modifying recipes, being active in a variety of ways, roles and responsibilities around eating, managing appetite, self esteem and teasing

While parents attended the lifestyle sessions, children in the group attended structured, supervised activity sessions developed by physical activity experts. The sessions consisted of fun, non‐competitive games designed around aerobic activity and development of fundamental motor skills. Sessions were designed as play rather than exercise and were diversional rather than interventional. The activities required minimal equipment and were deliverable by non‐expert staff and easily replicated at home. Sessions taken by a dietician

Waiting list control:
Received the same general healthy‐lifestyle pamphlet as the parenting‐alone group. During the 12‐month waiting list period, the waiting list control group was contacted by telephone 3 or 4 times for 5 minutes as a retention strategy. Researcher contact with the waiting list families was minimised to avoid the potential placebo effect of therapist contact

Outcomes

Outcomes reported in abstract of publication: BMI z score, waist circumference z score

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "Our goal was to evaluate the relative effectiveness of parenting‐skills training as a key strategy for the treatment of overweight children. The aim of this study was to evaluate the relative effectiveness of parenting‐skills training as a key strategy for the treatment of overweight children"

Notes

There were 3 comparisons of relevance to this review: the parent‐only intensive education group vs. the parent‐only group; the parent‐only + intensive education group vs. the waiting list control; the parent‐only group vs. the waiting list control

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote from publication: "Randomization schedules were computer generated using a 3‐block design stratified for gender and site of recruitment..."

Comment: researchers involved in recruitment, participant allocation and intervention delivery or data collection were not involved in the randomisation process

Allocation concealment (selection bias)

Low risk

Quote from publication: "Individual group allocations were sealed in opaque envelopes, with the next envelope opened on a child's completion of baseline measurements..."

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: carers and participants masked to allocation to treatment assignment but unclear if this also related to blinding throughout the trial

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Quote from publication: "...Data collection was performed by the same trained assessor who was blinded to participant group allocation"

Comment: outcome assessment was masked

Incomplete outcome data (attrition bias)
Objective outcomes

Unclear risk

Quote from publication: "Intention‐to‐treat analysis was performed, with all participants included in the analysis according to original group allocation, and follow‐up was maximized regardless of program attendance"

Comment: states ITT but the total number did not match

Selective reporting (reporting bias)

High risk

Comment: health‐related quality of life and satisfaction stated as outcomes but not reported

Other bias

Unclear risk

Comment: not enough detail to judge

Methods

Parallel randomised controlled trial

Randomisation ratio: not reported

Superiority design

Participants

Inclusion criteria: children > 20% overweight (BMI for age and sex > 85th percentile). Parents agreed to attend programme meetings. No current participation of any family member in a weight‐loss programme. No restriction regarding participation in a physical activity programme for children and parents. No diagnosis of psychiatric or major endocrine pathology

Exclusion criteria: current participation of any family member in a weight‐loss programme; restriction regarding participation in a physical activity programme for children and parents; diagnosis of psychiatric or major endocrine pathology

Diagnostic criteria: BMI for age and sex > 85th percentile

Interventions

Number of study centres: 1

Treatment before study: none

Titration period: none
Description of interventions:

Parent‐only group:

16 x 1 hour sessions at the following intervals: weeks 1‐10 (10 sessions); bi‐weekly ‐ weeks 11‐18 (4 sessions); monthly ‐ weeks 19‐26 (2 sessions). Nurturing the child emotionally. Problem solving. The first 3 sessions focused on nutrition education and parental modelling. In the next 2 sessions, the use of an authoritative feeding style was discussed. Sessions 6 and 7 focused on eating and activity behaviour modification, reinforcing means to influence a child's food preferences, as well as employing behaviour modification. Sessions 8 and 9 focused on problem solving while implementing
the change in the home. Sessions 10 and 11 dealt with cognitive restructuring and media management. Session 12 focused on coping with resistance. In the remaining 4 sessions, groups discussed their successes and difficulties, as well as recommendations on how to work around constraints imposed on parents in order to promote a healthy lifestyle for all family members

Physical activity goals of 4 hours per week, and decrease in sedentary behaviours (to < 3 hours/day)

Theoretical basis: parents as the exclusive agent of change. Authoritative feeding style. Nurturing. Parental modelling. Behaviour change. Based on previous work

Structured 12‐session programme (unclear if a manual). A clinical dietician, supervised by a family therapist, administered the programme. Training of dietician not reported

Parent and children group:

Similar in content; however, adapted to fit the children included

Outcomes

Outcomes reported in abstract of publication: % overweight at end of programme (6 months) and 1‐year follow‐up. Food stimuli in the home (from Family Eating and Activity questionnaire). Parents' weight

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Funding not stated

Publication status: peer‐reviewed journal

Stated aim for study

Quote from publication: "The question remains, which is better: parents only or parent and child treatment? The present study extends this knowledge by comparing targeting parents and child versus parents alone, to address the question: Do the children need to be involved at all?..."

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Comment: randomisation stratified by age groups: participants divided into age groups: 6‐7 years, 8‐9 years, 10‐11 years, then randomised. No details of randomisation schedule

Allocation concealment (selection bias)

Low risk

Quote from publication: "The process was carried out by using two concealed opaque envelopes indicating group 1, namely parents‐only, or group 2, parents and children"

Blinding of participants and personnel (performance bias)
Subjective outcomes

Unclear risk

Comment: no details provided

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: no details provided

Blinding of outcome assessment (detection bias)
Subjective outcomes

Low risk

Quote from publication: "The data were gathered by an MSc [Master of Science] student who was blinded to the treatment allocation"

Blinding of outcome assessment (detection bias)
Objective outcome

Low risk

Quote from publication: "The data were gathered by an MSc student who was blinded to the treatment allocation"

Incomplete outcome data (attrition bias)
Subjective outcomes

Low risk

Comment: ITT analysis where the missing values were replaced with baseline values. Reasonable attendance in both arms and numbers and reasons for drop‐outs given

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: ITT analysis where the missing values were replaced with baseline values. Reasonable attendance in both arms and numbers and reasons for drop‐outs given

Selective reporting (reporting bias)

Unclear risk

Comment: all outcomes reported as stated but not enough information to judge

Other bias

Unclear risk

Comment: although power calculations given, 12 participants in each arm seems a small number from the power calculation

Methods

Parallel randomised controlled trial

Randomisation ratio: superiority

Superiority design: 1 : 1 : 1

Participants

Inclusion criteria: overweight girls aged 5‐10 years. Children considered overweight if both their physician and parents recommended that they participate in the weight‐loss programme

Exclusion criteria: undergoing psychotherapy, drug therapy or involved in a weight‐reduction programme

Diagnostic criteria: not stated

Interventions

Number of study centres: assume 1

Treatment before study: none

Titration period: none
Intervention description:

Response‐cost plus reinforcement:

12‐week treatment. Parents given daily weight and calorie graphs, a calorie counter guide and an eating diary. Parents also given a weight reduction programme behavioural contract, instruction on daily exercise and an exercise programme (daily calisthenics that increased in difficulty over a 3‐week period, thereafter 30 minutes per day), nutritional information, instructions in stimulus control techniques, a book 'Living with Children' and information in reinforcement techniques, a daily reinforcement diary. At second baseline visit given a response‐cost contract to return the following week with money for deposit and a weight loss goal of between 1 and 2 pounds per week. Deposits were on a sliding scale of income vs. number of dependents and ranged between USD 12‐30. Money could be redeemed in 12 weekly instalments (25% weekly for attendance, 25% for bringing completed graphs and charts to the meeting, 50% if the child lost the agreed weight). Unearned money divided among the successful parents. Children weighed and then sent to a playroom. After the programme there was an 8‐week no contract follow‐up and following that a post follow‐up check 31 weeks later

Response‐cost:

Parents given the same as the response‐cost plus reinforcement group except did not receive the book, information on reinforcement techniques or the reinforcement diary

Control:

Informed would be able to participate at a later date (waiting list control)

Outcomes

Outcomes reported in abstract of publication: weight change

Study details

Run‐in period: none

Study terminated before regular end (for benefit/because of adverse events): no

Publication details

Language of publication: English

Non‐commercial funding

Publication status: peer‐reviewed publication

Stated aim for study

Quote from publication: "The present study treated with behavioural techniques overweight children 5 to 10 year of age"

Notes

There were 3 comparisons of relevance to this review: parent‐only + reinforcement vs. parent‐only; parent‐only + reinforcement vs. control; parent‐only vs. control

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Quote from publication: "subjects were randomly assigned to one of three groups"

Comment: no other details

Allocation concealment (selection bias)

Unclear risk

Comment: no details

Blinding of participants and personnel (performance bias)
Objective outcomes

Unclear risk

Comment: no details

Blinding of outcome assessment (detection bias)
Objective outcome

Unclear risk

Comment: no details

Incomplete outcome data (attrition bias)
Objective outcomes

Low risk

Comment: numbers and reasons for drop‐outs provided, differential drop‐out between groups (small numbers)

Selective reporting (reporting bias)

Unclear risk

Comment: not enough information to judge

Other bias

Unclear risk

Comment: not enough information to judge