Study name

Trial of Integrated Smoking Cessation, Exercise, and Weight Management in Serious Mental Illness: TRIUMPH

Methods

Randomised controlled trial

Participants

Smokers with a history of serious mental illness attending community mental health services and interested in quitting smoking

Interventions

An 18‐month comprehensive, practical tobacco smoking cessation programme integrating exercise and weight counselling vs treatment as usual

Outcomes

Primary outcomes: prolonged smoking abstinence, physical fitness, weight maintenance

Starting date

July 2016

Contact information

Gail L Daumit, MD, MHS

Johns Hopkins University

Notes

Study name

Metformin for Overweight and OBese ChILdren and Adolescents With BDS Treated With SGAs (MOBILITY)

Methods

A prospective, large, pragmatic, randomised trial. Open‐label. Parallel assignment

Participants

Children and adolescents from 8 to 17 years of age. Diagnosed or told by a clinician that they have any of the following bipolar spectrum disorders (BSDs): bipolar I, bipolar II, unspecified bipolar, and related disorders, disruptive mood dysregulation disorder (DMDD), cyclothymic disorder, other specified bipolar and related disorders, as well as mood disorder not otherwise specified (if diagnosed in the past as per DSM‐IV and body mass index > 85 percentile for age and sex by standard growth charts

Interventions

Two experimental arms: 1. MET and LIFE: participants randomised to this group will receive both metformin and lifestyle intervention. Participants randomised to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated at 2‐week intervals to ensure that each patient achieves maximum insulin‐sensitising effects of the drug while minimising the chance of side effects; 2. Healthy lifestyle intervention (LIFE): participants randomised to this group will receive lifestyle intervention alone. This healthy lifestyle intervention (LIFE) consists of counselling participants and families regarding a healthy eating plan, physical activity, and sedentary activities

Outcomes

Primary outcome: BMI z‐score

Secondary outcome: composite metabolic health and nutrition measure

Starting date

December 2015

Contact information

Melissa Delbello, Principal Investigator

University of Cincinnati

Notes

Study name

Lifestyle Intervention for Young Adults With Serious Mental Illness

Methods

Randomised controlled trial

Participants

Overweight and obese (BMI ≥ 25) young adults ages 18 to 35 with SMI, attending 1 of 2 community mental health centres who are interested in losing weight and improving fitness

Interventions

A 12‐month PeerFIT intervention vs basic education in fitness and nutrition supported by a wearable activity tracking device (BEAT) in achieving clinically significant improvements in weight loss and cardiorespiratory fitness

Outcomes

Primary outcomes:

1. Change in weight (time frame: baseline, 6 months, and 12 months). Participants' weight will be measured in pounds (lbs) on a flat, even surface with the use of a high‐quality, calibrated professional medical scale, with the participant wearing indoor clothing and no shoes
2. Change in 6‐minute walk test (time frame: baseline, 6 months, and 12 months). After a baseline blood pressure has been obtained, participants are asked to walk a measured distance as far as they are able in 6 minutes

Secondary outcomes:

1. Change in weight loss self‐efficacy assessed by the Weight Efficacy Lifestyle (WEL) questionnaire (time frame: baseline, 6 months, and 12 months). The Weight Efficacy Lifestyle (WEL) questionnaire will be used to measure self‐efficacy for weight loss. The WEL consists of 20 items designed to measure self‐confidence to control weight by resisting overeating in certain tempting situations. The total score will be used in analyses. Items are scored on a 10‐point Likert scale from 0 ("not confident") to 10 ("very confident") and total score calculated as the sum of individual item responses
2. Change in self‐efficacy for exercise behaviours assessed by the Self‐efficacy for Exercise Behaviors (SEB) scale (time frame: baseline, 6 months, and 12 months). The SEB scale will be used to measure participants' self‐efficacy related to the ability to exercise despite barriers. The 12‐item scale consists of common barriers that might affect participation in exercise (e.g. feeling depressed, socialising, stressful life changes, household chores). For each situation, participants use the scale from 1 ("I know I cannot") to 5 ("I know I can") to describe their confidence that they could exercise in the face of these barriers
3. Change in peer support for health behaviour change assessed by the 24‐item Social Provisions Scale (SPS) (time frame: baseline, 6 months, and 12 months). Participants' level of perceived peer support will be measured by the 24‐item SPS. The SPS assesses 6 types of support from social relationships (guidance, reliable alliance, reassurance of worth, attachment, social integration, and opportunity for nurturance), and the total score will be used in the analysis. Items are scored on a 4‐point Likert scale from 1 ("strongly disagree) to 4 ("strongly agree") as it pertains to relationships with group members. Higher scores indicate greater perceived support from group relationships
4. Change in serum lipids (time frame: baseline, 6 months, and 12 months). Lipids will be measured by the CardioChek PA Analyzer, a hand‐held dual testing system that produces values for total cholesterol, LDL, HDL, and triglycerides via a multi‐panel test strip and a single drop of blood acquired with a finger prick

Starting date

July 2017

Contact information

Principal Investigator: Kelly A Aschbrenner, PhD

Dartmouth‐Hitchcock and Geisel School of Medicine at Dartmouth College

Notes

Study name

Saxenda® in Obese or Overweight Patients With Stable Bipolar Disorder

Methods

A Randomised, Placebo‐Controlled Study of Liraglutide 3 mg Daily (Saxenda®)

Participants

Obese or overweight patients with stable bipolar disorder. Participants will have a DSM‐5 bipolar disorder that is clinically stable and will be obese (defined as BMI ≥ 30 mg/kg²) or overweight (defined as BMI ≥ 27 kg/m²) with at least 1 weight‐related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia

Interventions

Liraglutide 3 mg daily (Saxenda®) vs placebo

Outcomes

Primary outcome: percent change in body weight over 2 years

Starting date

April 2017

Contact information

Susan McElroy, Chief Research Officer

Lindner Center of HOPE

Notes

Study name

Peer Navigators to Address Obesity‐Related Concerns for African Americans With Serious Mental Illness

Methods

Randomised controlled trial

Participants

Obese with a history of mental illness

Interventions

"The behavioral weight loss intervention (BWLI) consists of an 8‐month intervention phase followed by a 4‐month maintenance phase. The initial intervention phase comprises four types of contact: (1) one‐hour to one and a half hour group weight management class led by facilitator (once per week); (2) 45‐minute physical activity class led by facilitator (1‐2 per week); (3) 20‐minute, individual visit with facilitator (once per month); (4) weigh‐in (once each week). Persons are randomly assigned to peer navigators to begin simultaneously with BWLI and run concurrently across the eight months of the intervention. PNs may work with participants to partner on BWLI homework, meet with participant and BWLI facilitator individually, attend healthcare appointments, and partner on tasks that arise out of those appointments"

Outcomes

Primary outcomes:

• Change in weight (time frame: 0, 6, 12, and 18 months)

• Change in waist circumference (time frame: 0, 6, 12, and 18 months)

Starting date

December 2017

Contact information

Patrick Corrigan, Distinguished Professor of Psychology

Illinois Institute of Technology

Notes

Study name

Micronutrients as Adjunctive Treatment for Bipolar Disorder

Methods

Randomised controlled trial

Participants

Stable adult outpatients with bipolar disorder, type I or II (DSM‐V criteria)

Interventions

Supplementation with a 36‐ingredient vitamin/mineral mix (Micronutrient) and an omega‐3 fatty acid supplement (fish oil) vs matched double placebo in a 3:2 ratio for a year

Outcomes

Primary outcome:

Composite z‐score for side effects, calculated from 3 separate z‐scores that measure medication dosage, illness intensity (Clinical Global Impression score), and adverse side effects (UKU Side Effect score)

Secondary outcomes:

• Symptom severity based on the Positive and Negative Symptom Scale (PANSS)

• Mania symptoms based on the Young Mania Rating Scale (YMRS)

• Anxiety symptoms based on the Hamilton Anxiety Scale (HAM‐A)

• Depression symptoms based on the Montgomery‐Asberg Depression Rating Scale (MADRS)

• Quality of life, patient‐reported by My Medical Outcome Profile version 2 (MYMOP‐2)

• Nutritional status based on the Mini Nutritional Assessment scale (MNA)

• Functionality, patient‐reported on the 24‐item Behavior and Symptom Identification Scale (BASIS‐24)

• Vital signs (waist circumference, body mass index, blood pressure, heart rate, respirations)

Starting date

May 2018

Contact information

Principal Investigator: Lewis Mehl‐Madrona, MD, PhD

Eastern Maine Medical Center

Notes

Study name

Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Serious Mental Illness (iOTA‐SMI)

Methods

Randomised controlled trial

Participants

Obese adults with a history of serious mental illness

Interventions

Behavioural: iOTA SMI:

Participants randomised to the iOTA SMI arm will undergo an assessment of individual behaviour risks, will participate in collaborative goal‐setting with a health coach, and will use an interactive text system that will provide ongoing support and self‐monitoring of behaviour change goals

Behavioural: health education control:

Participants randomised to the Health Education Control arm will receive monthly counselling on energy balance, physical activity, and nutrition

Outcomes

Primary outcome: change in BMI

Starting date

July 2018

Contact information

Principal Investigator: Ginger E Nicol, MD

Washington University of Medicine

Notes

Study name

Interactive Obesity Treatment Approach (iOTA) for Obesity Prevention in Adults With Early Serious Mental Illness: iOTA‐SMI (iOTA‐eSMI)

Methods

Randomised controlled trial

Participants

Overweight or obese adults with a history of serious mental illness

Interventions

Behavioural: iOTA text messaging intervention:

Over 6 months, participants in the iOTA arm will have monthly in‐person visits with a health coach who will work with participants to set goals for the upcoming month related to healthy eating and activity. Participants will receive daily text message health tips related to their goals and will be prompted once a week to respond with a text indicating their weight and how they are doing with their goals. Following the 6‐month active treatment phase, participants will receive text messages only for another 3 months

Behavioural: health education text messaging intervention:

Over 6 months, participants in the Health Ed arm will also have monthly in‐person visits with a health coach who will provide education on energy balance and problem‐solving. Specific goals will not be set, but the health coach will assist participants in problem‐solving any challenges. Participants will receive a weekly automated motivational text message health tip related to what they learned in their health coaching sessions. Following the 6‐month active treatment phase, participants will receive text messages only for another 3 months

Outcomes

Primary outcome: change in body mass index (time frame: baseline, 4, 8, 12, 16, 20, 24, and 36 weeks)

Starting date

June 2020

Contact information

Principal Investigator: Ginger E Nicol, MD

Washington University of Medicine

Notes

Study name

Effectiveness of a Psycho‐education Program in Patients With Severe Mental Disorder

Methods

Randomised controlled trial

Participants

Obese patients with a history of serious mental illness

Interventions

Psychopharmacology plus psycho‐education on healthy living habits over a 3‐month period

Outcomes

Primary outcome:

Change in weight (time frame: change from baseline in weight at 3 and 6 months)

Secondary outcomes:

Waist circumference (time frame: change from baseline in waist circumference at 3 and 6 months)

Waist‐hip ratio (time frame: change from baseline in waist‐hip ratio at 3 and 6 months)

Starting date

February 2020

Contact information

Principal Investigator: José Manuel Pérez Mármol, PhD

Department of Physiotherapy. Faculty of Health Sciences, University of Granada

Notes