Régimen dietético, actividad física e intervenciones conductuales para el tratamiento del sobrepeso o la obesidad en niños de edad preescolar hasta los 6 años
Resumen
Antecedentes
El sobrepeso y la obesidad en los niños han aumentado a nivel global y se puede asociar con consecuencias para la salud a corto y a largo plazo.
Objetivos
Evaluar los efectos del régimen dietético, la actividad física y las intervenciones conductuales para el tratamiento del sobrepeso o la obesidad en niños de edad preescolar hasta los seis años de edad.
Métodos de búsqueda
Se realizó una búsqueda sistemática de la literatura en las bases de datos Cochrane Library, MEDLINE, EMBASE, PsycINFO, CINAHL, y en LILACS, así como en en los registros de ensayos ClinicalTrials.gov y ICTRP Search Portal. También se verificaron las referencias de los ensayos identificados y las revisiones sistemáticas. No se aplicaron restricciones de idioma. La fecha de la última búsqueda fue marzo 2015 para todas las bases de datos.
Criterios de selección
Se seleccionaron los ensayos controlados aleatorios (ECA) de régimen dietético, actividad física e intervenciones conductuales para el tratamiento del sobrepeso o la obesidad en preescolares con edades de cero a seis años.
Obtención y análisis de los datos
Dos autores de la revisión evaluaron de forma independiente el riesgo de sesgo, evaluaron la calidad general de las pruebas utilizando el instrumento GRADE, y extrajeron los siguientes datos siguiendo el Manual Cochrane para las Revisiones Sistemáticas de Intervenciones (Cochrane Handbook for Systematic Reviews of Interventions). Se estableció contacto con los autores de los ensayos para obtener información adicional.
Resultados principales
Se incluyeron siete ECA con un total de 923 participantes: 529 se asignaron al azar a una intervención y 394 a un comparador. El número de participantes por ensayo osciló entre 18 y 475. Seis ensayos fueron ECA paralelos y uno fue un ECA grupal. Dos ensayos tuvieron tres brazos, y cada uno comparó dos intervenciones con un grupo control. Las intervenciones y los comparadores variaron en los ensayos. Las comparaciones se categorizaron en dos grupos: intervenciones con múltiples componentes e intervenciones dietéticas. La calidad general de las pruebas fue baja o muy baja y seis ensayos tuvieron un alto riesgo de sesgo en los criterios individuales del "Riesgo de sesgo". Los niños en los ensayos incluidos tuvieron un seguimiento de seis meses a tres años.
En los ensayos que compararon una intervención con múltiples componentes con atención habitual, atención habitual mejorada o control de información, se encontró una mayor reducción de la puntuación z del índice de masa corporal (IMC) en los grupos de intervención al final de la intervención (seis a 12 meses): diferencia de medias (DM) ‐0,3 unidades (intervalo de confianza [IC] del 95%: ‐0,4 a ‐0,2); P < 0,00001; 210 participantes; cuatro ensayos; pruebas de baja calidad, a los 12 a 18 meses de seguimiento: DM ‐0,4 unidades (IC del 95%: ‐0,6 a ‐0,2); P = 0,0001; 202 participantes; cuatro ensayos; pruebas de baja calidad, y a los dos años de seguimiento: DM ‐0,3 unidades (IC del 95%: ‐0,4 a ‐0,1); 96 participantes; un ensayo; pruebas de baja calidad.
Un ensayo indicó que no se informaron eventos adversos; los otros ensayos no informaron sobre eventos adversos. Tres ensayos informaron la calidad de vida relacionada con la salud y encontraron mejorías en algunos aspectos, pero no en todos. Otros resultados como el cambio conductual y la relación entre padres e hijos se midieron de manera inconsistente.
Un ensayo de tres brazos de pruebas de muy baja calidad que comparó dos tipos de régimen dietético con control encontró que el régimen dietético rico en lácteos (cambio en la puntuación z del IMC DM ‐0,1 unidades [IC del 95%: ‐0,11 a ‐0,09]; P < 0,0001; 59 participantes) y el régimen dietético con restricción energética (cambio en la puntuación z del IMC DM ‐0,1 unidades [IC del 95%: ‐0,11 a ‐0,09]; P < 0,0001; 57 participantes) dieron lugar a una mayor reducción del IMC que el comparador al final del período de intervención, pero solamente el régimen dietético rico en lácteos mantuvo dicha reducción al seguimiento a los 36 meses (cambio en la puntuación z del IMC DM ‐0,7 unidades (IC del 95%: ‐0,71 a ‐0,69); P < 0,0001; 52 participantes). El régimen dietético con restricción energética tuvo un resultado peor para el IMC que el control a dicho seguimiento (cambio en la puntuación z del IMC DM 0,1 unidades [IC del 95%: 0,09 a 0,11]; P < 0,0001; 47 participantes). No hubo diferencias significativas en el gasto de energía diario medio entre los grupos. No se midieron la calidad de vida relacionada con la salud, los efectos adversos, los puntos de vista de los participantes y la crianza.
Ningún ensayo informó la mortalidad por todas las causas, la morbilidad o los efectos socioeconómicos.
Todos los resultados se deben interpretar con cuidado debido a la baja calidad y a que las intervenciones y los comparadores fueron heterogéneos.
Conclusiones de los autores
Las intervenciones con múltiples componentes parecen ser una opción efectiva de tratamiento para los niños de edad preescolar con sobrepeso u obesidad hasta la edad de seis años. Sin embargo, las pruebas actuales son limitadas y en su mayoría los ensayos tuvieron un alto riesgo de sesgo. La mayoría de los ensayos no midieron los eventos adversos. Se han identificado cuatro ensayos en curso que se incluirán en futuras actualizaciones de esta revisión.
La función de las intervenciones dietéticas es más ambigua; un ensayo indicó que las intervenciones con lácteos pueden ser efectivas a más largo plazo, pero no los regímenes dietéticos con restricción energética. Este ensayo también tenía un alto riesgo de sesgo.
PICO
Resumen en términos sencillos
Régimen dietético, actividad física e intervenciones conductuales para el tratamiento del sobrepeso o la obesidad en niños de edad preescolar hasta los 6 años
Pregunta de la revisión
¿Cuán eficaz es el régimen dietético, la actividad física y las intervenciones conductuales para la reducción del peso en niños de edad preescolar con sobrepeso y obesidad?
Antecedentes
A nivel mundial cada vez más niños presentan sobrepeso y obesidad. Estos niños tienen mayores probabilidades de presentar problemas de salud, tanto en la infancia como en etapas posteriores de la vida. Se necesita más información acerca de qué funciona mejor para tratar este problema.
Características de los estudios
Se encontraron siete ensayos controlados aleatorios (estudios clínicos en los que las personas se colocan al azar en uno de dos o más grupos de tratamiento) que compararon régimen dietético, actividad física y tratamientos (intervenciones) conductuales (en los que se cambian o mejoran los hábitos) con diversos grupos control (que no recibieron tratamiento), administrados a 923 niños de edad preescolar con sobrepeso u obesidad hasta la edad de seis años. Se agruparon los estudios por el tipo de intervención. La revisión sistemática informó los efectos de las intervenciones con múltiples componentes y las intervenciones dietéticas en comparación con ninguna intervención, "atención habitual", atención habitual mejorada o algún otro tratamiento si también se administró en el brazo de intervención. Los niños de los estudios incluidos se monitorizaron (a lo que se le llama seguimiento) durante entre seis meses y tres años.
Resultados clave
La mayoría de los estudios informó la puntuación z del índice de masa corporal (IMC): el IMC es una medida de la grasa corporal y se calcula al dividir el peso (en kilogramos) por el cuadrado de la talla corporal medida en metros (kg/m²). En los niños, el IMC a menudo se mide de manera que tiene en cuenta el sexo, el peso y la talla según los niños crecen (puntuación z del IMC). Se resumieron los resultados de cuatro ensayos en 202 niños que informaron la puntuación z del IMC, que como promedio fue 0,4 unidades menor en los grupos de intervención con múltiples componentes en comparación con los grupos control. Unidades menores indican más pérdida de peso. Por ejemplo, una niña de cinco años de edad con una talla corporal de 110 cm y un peso corporal de 32 kg tiene un IMC de 26,4 y una puntuación z del IMC de 2,99. Si esta niña pierde 2 kg de peso en un año (y ganó 1 cm en talla), habría reducido su puntuación z del IMC en aproximadamente 0,4 unidades (su IMC sería 24,3 y su puntuación z del IMC 2,58). En consecuencia, el cambio promedio en el peso en las intervenciones con múltiples componentes fue 2,8 kg inferior que en los grupos control. Otros efectos de las intervenciones como las mejorías en la calidad de vida relacionada con la salud o la evaluación de la relación entre padres e hijos fueron menos claros, y la mayoría de los estudios no midió los eventos adversos. Ningún estudio investigó la muerte por cualquier causa, la morbilidad o los efectos socioeconómicos. Un estudio encontró que la reducción de la puntuación z del IMC fue mayor al final de las intervenciones dietéticas con regímenes ricos en lácteos y con restricción energética en comparación con una educación para un estilo de vida saludable solamente. Sin embargo, solamente el régimen dietético rico en lácteos siguió mostrando efectos beneficiosos a los dos a tres años después, mientras que el grupo de régimen con restricción energética tuvo un mayor aumento de la puntuación z del IMC que el grupo control.
Estas pruebas están actualizadas hasta marzo 2015.
Calidad de la evidencia
La calidad general de las pruebas fue baja o muy baja, principalmente porque solamente hubo pocos estudios por medida de resultado o el número de los niños incluidos fue pequeño. Además, muchos niños abandonaron los estudios antes de que hubieran terminado.
Conclusiones de los autores
Summary of findings
| Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children aged 0 to 6 years | ||||||
| Population: preschool children (aged 0 to 6 years) with overweight or obesity Settings: various Intervention: multicomponent interventions Comparison: usual care/enhanced usual care/information control/wait‐list control | ||||||
| Outcomes | Control | Multicomponent intervention | Relative effect | No of participants | Quality of the evidence | Comments |
| Changes in BMI and body weight a. BMI z scorea [units] Follow‐up: 12 to 18 months b. Weight [kg] Follow‐up: 12 to 18 months | a. The mean change in BMI z score ranged across control groups from ‐0.3 units to +0.4 units b. The mean change in weight ranged across control groups from +3.1 kg to +5.2 kg | b. The mean change in BMI z score in the intervention groups was 0.4 units lower (0.6 to 0.2 lower) b. The mean change in weight in the intervention group was 2.8 kg lower (4.4 to 1.2 lower) | ‐ | a. 202 (4) b. 202 (4) | a. ⊕⊕⊝⊝ b. ⊕⊕⊝⊝ | Lower units indicate more weight loss |
| Adverse events Follow‐up: 24 months | See comment | See comment | See comment | 88 (1) | ⊕⊝⊝⊝ | Only 1 trial (abstract only) reported on adverse events, stating no adverse events were observed |
| HrQoL and self esteem a. DUX 25 (Dutch Child AZL TNO Quality‐of‐Life tool: total score and 4 domains; scale 0 to 100; higher score indicates better HrQoL) Follow‐up: 12 months b. CHQ‐PF50 (Dutch edition of the Child Health Questionnaire Parent Form: 15 items; score 0 to 100; higher score indicates better HrQoL) Follow‐up: 12 months c. PedsQL (Pediatric Quality of Life Inventory, physical functioning subscale; higher score indicates better HrQoL) Follow‐up: 6 months/12 months d. PedsQL (total score) Follow‐up: 12 months | See comment | See comment | See comment | a. 40 (1) b. 40 (1) c. 17 (1) d. 16 (1) | a/b/c/d | No trials reported self esteem a. Change in median of the total score: +5 in the intervention group versus ‐5 in the control group; change in median of 1 of 4 domains (physical functioning): +8 in the intervention group versus ‐4 in the control group b. No statistically significant differences in any of the 15 items c. 6 months' change in mean: +9.5 units in the intervention group versus ‐1.7 units in the control group, data not reported for total score and 3 other subscales; 12 months' change in mean +13.8 units in the intervention group versus ‐2.7 units in the control group, data not reported for total score and 3 other subscales d. No substantial differences between multicomponent intervention and control group |
| All‐cause mortality | See comment | See comment | See comment | See comment | See comment | No trials reported all‐cause mortality |
| Morbidity | See comment | See comment | See comment | See comment | See comment | No trials reported morbidity |
| Parent‐child relationship or assessment of parenting | See comment | See comment | See comment | 44 (2) | ⊕⊝⊝⊝ | Limited data were reported, no substantial differences between intervention and control groups |
| Socioeconomic effects | See comment | See comment | See comment | See comment | See comment | No trials reported socioeconomic effects |
| BMI: body mass index; CI: confidence interval; HrQoL : health‐related quality of life | ||||||
| GRADE Working Group grades of evidence | ||||||
| a"A BMI z score or standard deviation score indicates how many units (of the standard deviation) a child's BMI is above or below the average BMI value for their age group and sex. For instance, a z score of 1.5 indicates that a child is 1.5 standard deviations above the average value, and a z score of ‐1.5 indicates a child is 1.5 standard deviations below the average value" (NOO NHS 2011). | ||||||
| Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children aged 0 to 6 years | ||||||
| Patient or population: preschool children (aged 0 to 6 years) with overweight or obesity Settings: obesity research clinic Intervention: dietary interventions + healthy lifestyle education Comparison: healthy lifestyle education | ||||||
| Outcomes | Healthy lifestyle education | Dietary intervention + healthy lifestyle education | Relative effect | No of participants | Quality of the evidence | Comments |
| Changes in BMI and body weight 1. Dairy‐rich diet a. BMI z score [units]a Follow‐up: 6 months b. BMI z score [units] Follow‐up: 36 months 2. Energy‐restricted diet a. BMI z score [units] Follow‐up: 6 months b. BMI z score [kg/m²] Follow‐up: 36 months | 1. Dairy‐rich diet a. The mean change in BMI z score was ‐0.5 units in the control group b. The mean change in BMI z score was +0.6 units in the control group 2. Energy‐restricted diet a. The mean change in BMI z score was ‐0.5 units in the control group b. The mean change in BMI z score was +0.6 units in the control group | 1. Dairy‐rich diet a. The mean change in BMI z score in the intervention group was b. The mean change in BMI z score in the intervention group was 2. Energy‐restricted diet a. The mean change in BMI z score in the intervention group was b. The mean change in BMI z score in the intervention group was | ‐ | 1. Dairy‐rich diet a. 59 (1) b. 52 (1) 2. Energy‐restricted diet a. 57 (1) b. 47 (1) | 1. Dairy‐rich diet a/b ⊕⊝⊝⊝ 2. Energy‐restricted diet a/b ⊕⊝⊝⊝ | Lower units indicate more weight loss 2 dietary interventions and 1 control compared in one 3‐arm randomised controlled trial (the number of participants in the control group was halved for the analysis and is shown here) |
| Adverse events | See comment | See comment | See comment | See comment | See comment | Not reported |
| Health‐related quality of life and self esteem | See comment | See comment | See comment | See comment | See comment | Not reported |
| All‐cause mortality | See comment | See comment | See comment | See comment | See comment | Not reported |
| Morbidity | See comment | See comment | See comment | See comment | See comment | Not reported |
| Parent‐child relationship or assessment of parenting | See comment | See comment | See comment | See comment | See comment | No trials reported parent‐child relationship or assessment of parenting |
| Socioeconomic effects | See comment | See comment | See comment | See comment | See comment | Not reported |
| *The basis for the assumed risk (e.g. the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| a"A BMI z score or standard deviation score indicates how many units (of the standard deviation) a child's BMI is above or below the average BMI value for their age group and sex. For instance, a z score of 1.5 indicates that a child is 1.5 standard deviations above the average value, and a z score of ‐1.5 indicates a child is 1.5 standard deviations below the average value" (NOO NHS 2011). bDowngraded by three levels because of reporting bias, indirectness, and imprecision (one trial only with small number of participants); see Appendix 9. | ||||||
Antecedentes
La prevalencia de niños y adolescentes con sobrepeso y obesidad ha aumentado en todo el mundo, y representa una crisis global de salud pública (Ng 2014; WHO 2015a). Aunque alguna vez se consideró un trastorno que afecta solamente a los países de altos ingresos, las tasas pediátricas de sobrepeso y obesidad recientemente se han comenzado a elevar extraordinariamente en algunos países de ingresos bajos y medios (Wang 2012). Al utilizar la definición estándar de la International Obesity Task Force (IOTF), la prevalencia estandarizada por la edad del sobrepeso y la obesidad en los niños y adolescentes ha aumentado en los países de ingresos altos, medios y bajos en los últimos 30 años (Cole 2000). En 2013 se calculó que la prevalencia de niños y adolescentes con sobrepeso y obesidad en los países de ingresos altos fue del 23,8% (intervalo de confianza [IC] del 95%: 22,9 a 24,7) para los niños y del 22,6% (IC del 95%: 21,7 a 23,6) para las niñas. En los países de ingresos bajos y medios se calculó que la prevalencia fue del 12,9% (IC del 95%: 12,3 a 13,5) en los niños y del 13,4% (IC del 95%: 13 a 13,9) en las niñas (Ng 2014). Los niños muy pequeños también están afectados. En 2010, de Onis 2010 utilizó las normas de crecimiento de la Organización Mundial de la Salud para calcular que más de 42 000 000 de niños menores de cinco años de edad presentaban sobrepeso u obesidad, y que aproximadamente 35 000 000 de estos niños vivían en países de ingresos bajos y medios (WHO 2015b).
También se han documentado desigualdades en la prevalencia del sobrepeso y la obesidad. En general, los niños desfavorecidos desde el punto de vista socioeconómico de los países de altos ingresos (Knai 2012; NCB 2015; Shrewsbury 2008), y los niños de nivel socioeconómico más alto en los países de ingresos bajos y medios (Lobstein 2004; Wang 2012), presentan un mayor riesgo de sobrepeso. Sin embargo, esta relación puede variar según las características demográficas de la población (por ejemplo, edad, género, grupo étnico) y el ambiente (por ejemplo, campo, zona urbana)(Wang 2012). Se ha observado que la prevalencia de la obesidad varía según el grupo étnico y existen grandes grupos de datos que muestran una variación étnica significativa en las poblaciones de niños ingleses (HSCIC 2015), estadounidenses (Freedman 2006; Skinner 2014) y neozelandeses (Rajput 2014).
Aunque hay algunas pruebas de que la tasa de aumento de la obesidad pediátrica puede estar disminuyendo en algunos países de ingresos altos, los niveles actuales aún son demasiado altos y se han elevado progresivamente en muchos países de ingresos bajos y medios (Olds 2011; Rokholm 2010). Sin embargo, una inquietud adicional en algunos países de altos ingresos como los EE.UU. Kelly 2013 y Skinner 2014,e Inglaterra, en CMO 2015 y Ells 2015, es el ascenso en la obesidad pediátrica grave. Aunque la IOTF publicó una definición internacional para la obesidad pediátrica grave (mórbida) en 2012 (Cole 2012), a menudo la prevalencia de la obesidad grave se informa mediante puntos de corte propios del país, lo que dificulta las comparaciones internacionales. Sin embargo, datos de EE.UU. en Skinner 2014, e Inglaterra, en Ells 2015, han mostrado que la prevalencia de la obesidad pediátrica grave varía según el nivel socioeconómico y el grupo étnico y puede dar lugar a un riesgo mayor de eventos adversos cardiometabólicos y a obesidad grave en la edad adulta (Kelly 2013).
Descripción de la afección
El sobrepeso y la obesidad en la niñez son resultado de una acumulación de grasa excesiva en el cuerpo, y puede aumentar el riesgo de consecuencias para la salud a corto y a más largo plazo. Se pueden desarrollar numerosas comorbilidades relacionadas con la obesidad durante la niñez, que incluyen afecciones musculoesqueléticas (Paulis 2014); factores de riesgo cardiovasculares como hipertensión, resistencia a la insulina e hiperlipidemia (Reilly 2003), incluso en niños muy pequeños (Bocca 2013); retraso motor y del desarrollo (Cataldo 2015); y trastornos como apnea del sueño (Narang 2012), asma(Egan 2013), enfermedad hepática, y diabetes tipo 2 (Daniels 2009; Lobstein 2004). El trastorno también puede afectar el bienestar psicosocial; los jóvenes con obesidad pueden ser susceptibles a una reducción en la autoestima y la calidad de vida (Griffiths 2010),así como la estigmatización (Puhl 2007; Tang‐Peronard 2008). Las pruebas también muestran que la obesidad en la niñez puede continuar hasta la edad adulta (Parsons 1999; Singh 2008; Whitaker 1997), y por lo tanto se asocia con un mayor riesgo de salud deficiente en etapas posteriores de la vida (Reilly 2011).
Descripción de la intervención
Debido a las graves implicaciones asociadas con la obesidad en la niñez y la adolescencia, es imperativo lograr un tratamiento efectivo. Aunque los principios fundamentales del control del peso en los niños y adolescentes son los mismos que en los adultos (es decir, reducción del aporte calórico y mayor gasto de energía), el objetivo primario del tratamiento (es decir, reducción del peso o desaceleración del aumento de peso) y el enfoque de intervención más apropiado varían y dependen de la edad y el grado de peso excesivo del niño, entre otras consideraciones. Se ha mostrado que las intervenciones familiares que combinan componentes dietéticos, actividad física y componentes conductuales son eficaces y se consideran la práctica adecuada actual en el tratamiento de la obesidad en los niños menores de 12 años de edad (Oude Luttikhuis 2009).
Efectos adversos de la intervención
No se prevé que el régimen dietético, la actividad física y las intervenciones conductuales darán lugar a resultados adversos. Sin embargo, al igual que todas las intervenciones para el tratamiento de la obesidad en niños y jóvenes, se deben considerar posibles efectos adversos que incluyen los efectos sobre el crecimiento lineal, los trastornos en los hábitos alimenticios y el bienestar psicológico.
De qué manera podría funcionar la intervención
El ambiente doméstico es importante en la etiología de la obesidad de la niñez y los padres desempeñan una gran función en la elección de los alimentos y la actividad física de los niños. En encuestas en los EE.UU. Wansink calculó que el "guardián nutricional" (el que compra y cocina los alimentos) controla el 72% de los alimentos que comen los niños dentro y fuera del hogar (Wansink 2006). Una revisión sistemática realizada por Clark y cols. indicó que un nivel alto de restricción paterna de los refrigerios se asocia con un mayor aporte energético y aumento de peso en los niños (Clark 2007). Por el contrario, se ha mostrado que el control "encubierto" del consumo de alimentos en los niños al controlar el ambiente nutricional domiciliario para limitar la exposición a alimentos no saludables (es decir, no comprar alimentos no saludables) disminuye la ingesta de refrigerios no saludables en comparación con el control "manifiesto" (es decir, comprar refrigerios pero no permitir el acceso) (Ogden 2006). En cuanto a la actividad física, una revisión sistemática indicó que el apoyo paterno se asocia firmemente con niveles de actividad física en los niños, aunque la influencia del modelo paterno de ser ellos mismos físicamente activos fue inconsistente(Gustafson 2006).
Un funcionamiento familiar deficiente, como la comunicación deficiente y niveles altos de conflictos, también se asocia con un riesgo mayor de obesidad en los niños(Halliday 2014). El estilo de crianza autoritario se asocia con un riesgo menor de obesidad en los niños, en comparación con otros estilos de crianza(Sleddens 2011). Debido a la importancia de la función de los padres en el ambiente doméstico y la importancia de los estilos y aptitudes para la crianza, los padres se han definido como "agentes del cambio" en la familia para la intervención con niños menores de 12 años de edad con obesidad(Golan 2004). Además, los propios niños pequeños son receptivos a la educación temprana y sanitaria basada en hechos(Baxter 2015). Los estudios de investigación cualitativa indican que las intervenciones para los niños en edad preescolar se deben orientar a promover el modelo paterno de comportamientos positivos, crear ambientes domiciliarios y preescolares que promuevan los regímenes dietéticos saludables, y dirigirse simultáneamente a los factores objetivos a nivel de la familia y preescolar / guardería (Paes 2015).
Por qué es importante realizar esta revisión
La primera versión de esta revisión sistemática se publicó en 2003 e incluyó el análisis de ensayos de tratamiento de la obesidad en la niñez publicados hasta julio de 2001 (Summerbell 2003). La segunda versión fue publicada en 2009, actualizando la revisión de 2003 (Oude Luttikhuis 2009).
Para reflejar el crecimiento rápido en esta área, la tercera actualización de esta revisión se ha dividido en seis revisiones que se centran en los siguientes enfoques terapéuticos: cirugía; fármacos; intervenciones solamente para padres; régimen dietético, actividad física e intervenciones conductuales para niños pequeños hasta los seis años de edad; niños escolares de seis a 11 años de edad; y adolescentes de 12 a 17 años.
La presente revisión examina la efectividad de las intervenciones para los niños de edad preescolar hasta los seis años de edad. Las revisiones sistemáticas anteriores identificaron una falta de ensayos controlados aleatorios que evaluaran las intervenciones en niños en edad preescolar (Bluford 2007; Bond 2009; Bond 2011; Oude Luttikhuis 2009), sin embargo, desde entonces se han publicado varios ensayos.
Los resultados de esta revisión actual y otras revisiones sistemáticas de esta serie proporcionarán datos para informar las guías clínicas y la política sanitaria para el tratamiento de la obesidad en la niñez.
Objetivos
Evaluar los efectos del régimen dietético, la actividad física y las intervenciones conductuales para el tratamiento del sobrepeso o la obesidad en niños de edad preescolar hasta los seis años de edad.
Métodos
Criterios de inclusión de estudios para esta revisión
Tipos de estudios
Se incluyeron los ensayos clínicos controlados aleatorios con al menos seis meses de seguimiento.
Tipos de participantes
Se incluyeron los ensayos en niños con sobrepeso u obesidad con una edad media al momento del ensayo de cero a seis años al comienzo de la intervención. Se excluyeron los niños en estado grave o con una causa sindrómica de la obesidad (por ejemplo Prader‐Willi).
Tipos de intervenciones
Se planificó investigar las siguientes comparaciones de intervención versus control / comparador.
Intervención
Cualquier forma de intervención en el estilo de vida con el objetivo primario de tratar el sobrepeso o la obesidad en los niños (cualquier forma de régimen dietético, actividad física o terapia conductual administrada como intervenciones con un componente único o múltiples componentes).
Comparador
La comparación podría ser ninguna intervención, atención habitual (como se hubiera definido) o un tratamiento concomitante alternativo, siempre que se administrara en el brazo de intervención.
Las intervenciones concomitantes debían ser las mismas en los grupos intervención y comparador para establecer comparaciones justas.
Tipos de medida de resultado
Resultados primarios
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Cambios en el índice de masa corporal (IMC) y el peso corporal.
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Eventos adversos.
Resultados secundarios
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Calidad de vida relacionada con la salud y autoestima.
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Mortalidad por todas las causas.
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Morbilidad.
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Medidas antropométricas diferentes del IMC.
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Cambio conductual.
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Puntos de vista de los participantes acerca de la intervención.
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Relación entre padres e hijos o evaluación de la crianza.
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Efectos socioeconómicos con medidas validadas.
Método y momento adecuado de la medición de resultados
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Cambios en el IMC (kg/m²) y el peso corporal (kg): medidos al inicio y por lo menos a los seis meses.
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Eventos adversos: definidos como un resultado adverso que ocurre durante o después de la intervención pero que no necesariamente es causado por la misma, y medido al inicio y por lo menos a los seis meses.
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Calidad de vida relacionada con la salud: evaluada con un instrumento validado como el Paediatric Quality of Life Inventory y medida al inicio y por lo menos a los seis meses.
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Mortalidad por todas las causas: definida como cualquier muerte que ocurrió durante o después de la intervención y medida a los seis meses o posteriormente.
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Morbilidad: definida como enfermedad o efecto perjudicial asociado con la intervención y medido al inicio y a los seis meses o después.
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Medidas antropométricas diferentes del cambio en el IMC: definidas con el uso de herramientas validadas como la circunferencia de la cintura, el espesor del pliegue cutáneo, la relación cintura‐cadera, la absorciometría de rayos X de energía dual o el análisis bioeléctrico de impedancia, y medidas al inicio y por lo menos a los seis meses.
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Cambio conductual: definido como medidas validadas del régimen dietético y la actividad física y medido al inicio y por lo menos a los seis meses.
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Puntos de vista de los participantes acerca de la intervención: definidos como relatos documentados de la retroalimentación del participante y medidos al inicio y por lo menos a los seis meses.
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Relación entre padres e hijos o evaluación de la crianza: evaluada por un instrumento validado y medida al inicio y por lo menos a los seis meses.
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Efectos socioeconómicos: definidos como una medida validada del nivel socioeconómico como los ingresos paternos o el nivel educacional y medidos al inicio y por los menos a los seis meses.
Resumen de los hallazgos
Se presenta una tabla de "Resumen de los hallazgos" que informa los siguientes resultados, listados según la prioridad.
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Cambios en el IMC y el peso corporal.
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Eventos adversos.
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Calidad de vida relacionada con la salud.
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Mortalidad por todas las causas.
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Morbilidad.
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Relación entre padres e hijos o evaluación de la crianza.
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Efectos socioeconómicos.
Results
Description of studies
For a detailed description of trials, see the Characteristics of included studies, Characteristics of excluded studies, and Characteristics of ongoing studies sections.
Results of the search
The searches generated 13,784 hits after duplicates were removed. Screening of titles and abstracts identified 105 papers to evaluate for formal inclusion and exclusion. Seven completed randomised controlled trials (RCTs) fulfilled the inclusion criteria and were included in the review. For a detailed description of the included trials, see Characteristics of included studies. We also identified four ongoing trials; see Characteristics of ongoing studies. We have presented the flow of trials through the review in Figure 1.
Study flow diagram.
Included studies
For a detailed description of the characteristics of included trials, see Characteristics of included studies and Appendix 2; Appendix 3; Appendix 4; Appendix 5; Appendix 6; Appendix 7; Appendix 8; Appendix 11). The following is a succinct overview.
Source of data
We obtained the majority of data presented in the review from published literature, including supplementary published data and trials registers where available. For three trials, data were provided via correspondence with the trial authors (Appendix 10).
Comparisons
We identified two main comparisons: six trials compared multicomponent interventions versus control (Bocca 2012; Lanigan 2010; Quattrin 2012; Stark 2011; Stark 2014; Taveras 2011), and one trial compared dietary interventions versus control (Kelishadi 2009).
Overview of trial populations
The seven trials included a total of 923 participants, with over half of these from just one trial (Taveras 2011). In total, 529 participants were randomised to an intervention and 394 to a comparator. The proportion of participants finishing the trial was lowest in Bocca 2012 at three years' follow‐up (39%), however data at this follow‐up are not yet available for inclusion in the review. Similarly, two‐year data (48% follow‐up) are not yet available for Lanigan 2010. For follow‐up reported in this review, the proportion of participants finishing the trial ranged from 47% to 93% in the intervention groups and 71% to 94% in the comparator groups. Individual sample size ranged between 18 and 475. See Table 1 for details.
Trial design
Six trials were parallel comparisons with individual randomisation. One trial was a cluster RCT (Taveras 2011), where the primary care practice was the unit of randomisation. All seven RCTs had a superiority design. Two RCTs had three comparisons (two intervention groups and one usual care or control arm) (Kelishadi 2009; Stark 2014); the remaining trials had two comparison groups. Five trials were single‐centre trials (Bocca 2012; Kelishadi 2009; Lanigan 2010; Stark 2011; Stark 2014), one trial was conducted in four centres (Quattrin 2012), and the cluster RCT was undertaken in 10 centres (Taveras 2011).
Trials were performed from 2003 to 2013. The duration of the interventions was six months in four trials (Kelishadi 2009; Lanigan 2010; Stark 2011; Stark 2014), and ranged from 16 weeks, in Bocca 2012, to two years, in Taveras 2011. The duration of follow‐up ranged from 12 months to three years. One trial terminated before regular end (after 105 families were recruited), as preliminary analysis indicated efficacy (Bocca 2012).
Settings
The interventions were carried out in an outpatient setting in three trials (Bocca 2012; Stark 2011; Stark 2014), primary care in two trials (Quattrin 2012; Taveras 2011), a community setting in one trial (Lanigan 2010), and an obesity research clinic in one trial (Kelishadi 2009). Four trials were conducted in the USA (Quattrin 2012; Stark 2011; Stark 2014; Taveras 2011), and one was conducted in each of the Netherlands (Bocca 2012), UK (Lanigan 2010), and Iran (Kelishadi 2009).
Participants
The diagnostic criteria for overweight and obesity differed between the trials. Two trials included children with BMI on or above the 85th percentile and who had a parent with BMI 27 or more, in Quattrin 2012, or BMI over 25, in Taveras 2011. The latter trial also included children with BMI on or above the 95th percentile and no overweight parent. Three other trials included children with BMI on or above the 95th percentile (Kelishadi 2009; Stark 2011; Stark 2014); two of these trials also specified BMI less than 100% above mean BMI and a parent with BMI 25 or more (Stark 2011; Stark 2014). Lanigan 2010 included children with BMI on or above the 91st percentile or whose weight had crossed centiles upwards, and Bocca 2012 included children who were 'overweight or obese' as defined by the International Obesity Task Force.
The age range for trial eligibility was 1 to 5 years (Lanigan 2010), 2 to 5 years (Quattrin 2012; Stark 2011; Stark 2014), 3 to 5 years (Bocca 2012), and 2 to 6.9 years (Taveras 2011). Kelishadi 2009 did not specify an age range. The mean age of children included in the trials ranged from 4 to under 6 years in six of the seven trials, and was 2.5 years in Lanigan 2010. The proportion of girls varied from 25% to 80%, but was not reported by one trial (Kelishadi 2009). Five trials reported mean BMI (Bocca 2012; Kelishadi 2009; Lanigan 2010; Quattrin 2012; Taveras 2011), which ranged from 18 to 22.7, and five trials reported BMI z score (Bocca 2012; Lanigan 2010; Quattrin 2012; Stark 2014; Taveras 2011), which ranged from 1.0 to 2.7. Stark 2011 reported mean BMI percentile (98 to 99). Mean parental BMI was 36 to 37 in the one trial reporting this (Quattrin 2012). Taveras 2011 reported the proportions of parents with BMI less than 25 (3% to 5%), 25 to 30 (36% to 52%), and 30 or more (44% to 61%).
Five of the seven trials reported ethnicity. The proportion of participants categorised as white was over 70% in four of the trials (Lanigan 2010; Quattrin 2012; Stark 2011; Stark 2014), and 47% to 70% in the fifth trial (Taveras 2011). Five trials reported socioeconomic status using different indicators (Hollingshead score, Hollingshead classification, family income, non‐manual social class, or parental educational attainment) (Lanigan 2010; Quattrin 2012; Stark 2011; Stark 2014; Taveras 2011).
Interventions
The interventions in six of the seven trials included a combination of nutritional, physical activity, and behavioural components, although approaches differed between the trials (Bocca 2012; Lanigan 2010; Quattrin 2012; Stark 2011; Stark 2014; Taveras 2011). See Characteristics of included studies and Appendix 2 for details of each trial. Two trials reported the same intervention, 'Learning about Activity and Understanding Nutrition for Child Health' (LAUNCH), which involved 18 group‐based clinic sessions and individual home visits over six months, targeting lifestyle behaviour modification and parenting skills (Stark 2011; Stark 2014). Stark 2014 also compared a less intensive mode of delivery, which was identical to the former except that individual home visits were not undertaken. Quattrin 2012 reported a family‐based parenting and behavioural intervention involving 13 group sessions over 12 months, individual meetings to shape goals, and 10 phone calls in between sessions. Bocca 2012 assessed a multidisciplinary intervention involving dietary advice, physical activity sessions, and psychological counselling for parents, with a total of 25 sessions over 16 weeks. Taveras 2011 reported 'High Five for Kids', a behavioural intervention using motivational interviewing face‐to‐face and by telephone, educational modules, and behavioural goal setting. The intensive phase of the intervention lasted for 12 months followed by a 12‐month maintenance phase, although no details were reported of this. Lanigan 2010 assessed the 'Trim Tots' healthy lifestyle programme, which included nutritional education, physical activity, and behavioural change components. Sessions were delivered in the community twice weekly for three months, then weekly for three months.
The comparators in these six trials were enhanced usual care (Stark 2011; Stark 2014), information control (Quattrin 2012), usual care (Bocca 2012; Taveras 2011), or a wait‐list control (Lanigan 2010), with differences between trials in the intensity and amount of contact (Characteristics of included studies; Appendix 2).
One trial compared two dietary approaches (dairy rich and energy restricted) plus healthy lifestyle education versus healthy lifestyle education alone (Kelishadi 2009). The family‐centred education sessions focused on health, nutrition, and physical activity and occurred monthly over six months in all three groups.
Outcomes
Six of seven trials explicitly stated a primary/secondary endpoint in the publication (Appendix 5). The most commonly defined primary outcome in the publications was a BMI variable: BMI z score (Bocca 2012; Lanigan 2010; Stark 2011; Stark 2014), BMI (Taveras 2011), or percent BMI overweight (Quattrin 2012). Where reported, primary outcomes defined in publications reflected those defined in trial registers, although in three trial publications (Bocca 2012; Stark 2011; Stark 2014), a greater number of outcomes were specified as primary. In Lanigan 2010, the primary outcome was specified as BMI in the trial register and BMI z score in the publication. Only one of seven trials reported on adverse events (Lanigan 2010), two reported health‐related quality of life (Bocca 2012; Stark 2011), five reported behaviour change (Bocca 2012; Kelishadi 2009; Stark 2011; Stark 2014; Taveras 2011), two reported participant views of the intervention (Stark 2011; Taveras 2011), and two reported parent‐child relationship or assessment of parenting (Stark 2011; Stark 2014). No trials investigated all‐cause mortality, morbidity, or socioeconomic effects. All seven trials provided a definition of endpoint measurement for BMI (Appendix 7). One trial was published as an abstract only, and a number of secondary outcomes are not yet available (Lanigan 2010).
Excluded studies
After evaluation of the full publication, we excluded 82 of 105 full‐text articles. The main reasons for exclusion were the types of participants included and the trial design not being an RCT with at least six months' duration. Many trials had multiple reasons for exclusion (for further details see Characteristics of excluded studies, which lists the 12 trials with the most uncertainty regarding inclusion).
Risk of bias in included studies
For details on risk of bias of included trials, see Characteristics of included studies. For an overview of review authors' judgements about each 'Risk of bias' item for individual trials and across all trials, see Figure 2 and Figure 3.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials (blank cells indicate that the particular outcome was not investigated in some trials).
Risk of bias summary: review authors' judgements about each risk of bias item for each included study (blank cells indicate that the study did not report that particular outcome).
Allocation
All seven trials reported adequate sequence generation, but only three described allocation concealment (Lanigan 2010; Stark 2011; Stark 2014). The risk of selection bias is therefore uncertain in four of the seven included trials.
Blinding
We judged only one trial to have a low risk of performance bias, as participants and personnel were blinded to treatment allocation (Quattrin 2012). Three trials did not undertake blinding of participants and personnel (Lanigan 2010; Stark 2011; Stark 2014); we judged these trials to have a high risk of performance bias for both objective and subjective outcomes (where reported). The risk of performance bias was unclear in three trials: one was described as single blind (Bocca 2012), and another as double‐blind (in the trial record only), but it was unclear who was blinded and how this was achieved (Taveras 2011), and in the third blinding was not reported (Kelishadi 2009).
We judged the risk of detection bias to be low for objective outcomes in all trials, regardless of whether or not outcome assessors were blinded. Two trials reporting subjective outcomes did not undertake blinding of outcome assessors (Stark 2011; Stark 2014); we judged these trials to have a high risk of detection bias for subjective outcomes. The risk of detection bias for subjective outcomes was unclear in three trials, either because blinding was not reported or it was unclear who was blinded and how this was achieved (Bocca 2012; Kelishadi 2009; Taveras 2011).
Incomplete outcome data
We judged the risk of attrition bias to be low in three trials (Bocca 2012; Kelishadi 2009; Stark 2011). Three trials had an imbalance in attrition between groups and were judged to have a high risk of attrition bias (Lanigan 2010; Quattrin 2012; Stark 2014). The risk of attrition bias was unclear for one trial that did not report reasons for attrition and only reported baseline and results data for participants completing the trial (Taveras 2011).
Selective reporting
We judged only two trials to have a low risk of selective reporting bias (Stark 2011; Taveras 2011). We judged the remaining five trials to have a high risk of selection bias, due to some outcomes being incompletely reported or not reported at all.
Other potential sources of bias
There was a low risk of bias from other sources in four trials (Bocca 2012; Lanigan 2010; Stark 2011; Taveras 2011). We judged the risk of bias from other sources to be unclear in the remaining three trials.
Effects of interventions
See: Summary of findings for the main comparison ; Summary of findings 2
Multicomponent interventions versus control
Six trials compared multicomponent interventions with usual care, enhanced usual care, information control, or wait‐list control. One trial assessed two interventions, LAUNCH with home visits and LAUNCH without home visits (described in the analyses as LAUNCH clinic only) (Stark 2014). Stark 2011 also assessed LAUNCH (with home visits). The other four trials each assessed different multicomponent interventions (Bocca 2012; Lanigan 2010; Quattrin 2012; Taveras 2011).
We considered outcomes here at the end of the intervention (if six months or longer) and at any follow‐up period. The intervention period was six months in three trials (Lanigan 2010; Stark 2011; Stark 2014), and 12 months in two trials (Quattrin 2012; Taveras 2011). The intervention was 16 weeks in one trial (Bocca 2012); we did not include outcomes at this time point in this review. Four trials reported outcomes at 12 months, in Bocca 2012, Stark 2011 and Stark 2014, or 18 months, in Quattrin 2012, from baseline (six to eight months from end of intervention), and one trial, Quattrin 2012, reported outcomes at 24 months (12 months from end of intervention). Lanigan 2010 followed participants for 24 months, but data are not yet available. Bocca 2012 followed participants for 36 months, but data at this time point were not reported in a useable format.
The proportion of participants finishing the trial (or the longest reported follow‐up, if different) was less than 80% in four trials, Bocca 2012, Lanigan 2010, Quattrin 2012, Stark 2014, out of the six (Table 1), moreover there was a differential rate of losses to follow‐up between groups in three of these trials (Lanigan 2010; Quattrin 2012; Stark 2014). Attrition was highest in the multicomponent intervention arms of Lanigan 2010 and Quattrin 2012, and the LAUNCH home visits arm of Stark 2014 (although both intervention arms had higher attrition than the enhanced usual care arm in this trial).
Primary outcomes
Changes in body mass index (BMI) and body weight
All six trials reported BMI z score (Bocca 2012; Lanigan 2010; Quattrin 2012; Stark 2011; Stark 2014; Taveras 2011). Pooling the studies in a random‐effects meta‐analyses (Analysis 1.1) demonstrated a reduction in BMI z score in the intervention groups compared with controls at the end of intervention: mean difference (MD) ‐0.26 units (95% confidence interval (CI) ‐0.37 to ‐0.16); P < 0.00001; 210 participants; 4 trials; low‐quality evidence). At 12 to 18 months' follow‐up, the MD was ‐0.38 units (95% CI ‐0.58 to ‐0.19); P = 0.0001; 202 participants; 4 trials; low‐quality evidence). One trial, Quattrin 2012, reported outcomes at 24 months' follow‐up (12 months' postintervention) and found the benefit was maintained (MD ‐0.25 units (95% CI ‐0.40 to ‐0.10)). One cluster RCT comparing intervention with control reported a change in BMI z score from baseline to one year of 0.05 units (95% CI ‐0.14 to 0.04); P = 0.28 (Taveras 2011).
Three trials reported BMI at the end of intervention or postintervention: Lanigan 2010 showed a MD of ‐0.40 kg/m² (95% CI ‐0.85 to 0.05) in 64 participants, and the cluster RCT by Taveras 2011 an adjusted (child age, sex, ethnicity, parent education, overweight/obesity status at baseline, household income, time elapsed from baseline to follow‐up) MD of ‐0.21 kg/m² (95% CI ‐0.50 to 0.07) in 445 participants. Eight months' postintervention, Bocca 2012 reported a MD of ‐1.00 kg/m² (95% CI ‐1.79 to ‐0.21) in 57 participants (Analysis 1.2).
Three of the trials reporting BMI z score also reported additional BMI variables, including changes in percent over BMI (Analysis 1.3) and BMI percentile (Analysis 1.4), which reflected the results in BMI z score.
Five trials reported change in body weight (Bocca 2012; Lanigan 2010; Quattrin 2012; Stark 2011; Stark 2014) (Analysis 1.5). Pooling the trials in a random‐effects meta‐analysis showed less weight gain with the interventions compared with control at the end of the intervention: MD ‐1.18 kg (95% CI ‐1.91 to ‐0.45); P = 0.001; 210 participants; 4 trials; low‐quality evidence) and at 12 to 18 months' follow‐up: MD ‐2.81 kg (95% CI ‐4.39 to ‐1.22); P = 0.0005; 202 participants; 4 trials; low‐quality evidence).
One trial, Quattrin 2012, reported change in body weight at 24 months' follow‐up (12 months' postintervention) and found the benefit was maintained: MD ‐1.60 kg (95% CI ‐2.42 to ‐0.78); 96 participants). Follow‐up was low (58%) in the intervention arm of this trial.
Three trials reported change in parental BMI or weight (Quattrin 2012; Stark 2011; Stark 2014); these trials required the parent to have a BMI of least 25 or 27 for trial inclusion. Pooling the trials in a meta‐analysis demonstrated a reduction in parental BMI in the intervention group compared with controls at the end of intervention (6 or 12 months) (MD ‐2.00 kg/m² (95% CI ‐2.52 to ‐1.48); P < 0.00001; 113 participants; 2 trials; low‐quality evidence) and at 12 to 18 months' follow‐up (MD ‐2.08 kg/m² (95% CI ‐2.65 to ‐1.51); P < 0.00001; 112 participants; 2 trials; low‐quality evidence). Quattrin 2012 also reported outcomes at 24 months' follow‐up, where the effect remained stable (MD ‐2.00 kg/m² (95% CI ‐2.57 to ‐1.43); 96 participants) (Analysis 1.6).
The effect on parental body weight was similar (Analysis 1.7), with parents in the intervention group reducing weight by around 5 kg more than the control group at the end of the intervention (MD ‐4.69 kg (95% CI ‐7.27 to ‐2.11); P = 0.0004; 146 participants; 3 trials; low‐quality evidence) and at 12 to 18 months' follow‐up (MD ‐5.14 kg (95% CI ‐8.96 to ‐1.33); P = 0.008; 49 participants; 2 trials; low‐quality evidence). Only one trial reported outcomes at 24 months' follow‐up (Quattrin 2012), where the effects remained (MD ‐6.70 kg (95% CI ‐8.42 to ‐4.98)).
Adverse events
Only one trial reported, as an abstract only, on adverse events (Lanigan 2010), stating that no adverse events were observed (Appendix 8). Further details, such as how adverse events were monitored, were not provided.
Secondary outcomes
Health‐related quality of life and self esteem
Three trials reported health‐related quality of life (Bocca 2012; Stark 2011; Stark 2014), but measures and scores used varied between trials (Appendix 11). Bocca 2012 reported two tools, the Dutch Child AZL TNO Quality‐of‐Life (DUX‐25), which measures daily activities, and the Dutch edition of the Child Health Questionnaire Parent Form (CHQ‐PF50), which measures health perception. At 12 months' follow‐up (eight months postintervention), a statistically significant higher increase was found in 40 participants in the multidisciplinary intervention group compared with the usual care group in the DUX‐25 total score (change in median of the total score: +5 in the intervention group versus ‐5 in the control group; 0 to 100 scale with higher scores indicating better health‐related quality of life) and in one of four domains (physical score; change in median: +8 in the intervention group versus ‐4 in the control group; with higher scores indicating better health‐related quality of life), but no substantial differences were found in any of the 15 items on the CHQ‐PF50 (Analysis 1.8; Analysis 1.9). Parents of 50% to 57% of randomised children completed questionnaires.
Stark 2011 reported the Pediatric Quality of Life Inventory (PedsQL) Generic Core scales, using the total score and the physical functioning, emotional functioning, and social functioning subscales, however only data for physical functioning were reported. A statistically significant improvement (higher scores indicate better quality of life) in the change in health‐related quality of life in physical functioning was found at the end of intervention (six months, mean +9.5 units in the intervention group versus ‐1.7 units in the control group) and at 12 months' follow‐up (mean +13.8 units in the intervention group versus ‐2.7 units in the control group) (Analysis 1.10).
Stark 2014 used the parent version of the PedsQL (total score) and found no substantial differences between multicomponent interventions and control in the total score (Analysis 1.11).
No trials measured self esteem.
All‐cause mortality
Not reported.
Morbidity
Not reported.
Anthropometric measures other than BMI
One trial reported waist circumference at the end of the six‐month intervention (Lanigan 2010) (Analysis 1.12), and one trial reported a number of anthropometric measures at 12 months' follow‐up (eight months after intervention end) (Bocca 2012), including waist circumference (Analysis 1.12), waist circumference z score (Analysis 1.13), hip circumference (Analysis 1.14), hip circumference z score (Analysis 1.15), upper arm circumference (Analysis 1.16), per cent body fat (Analysis 1.17), fat‐free mass (Analysis 1.18), visceral fat (Analysis 1.19), and subcutaneous fat (Analysis 1.20). Although these outcomes tended to favour the intervention, differences were only statistically significant for upper arm circumference and visceral fat. Caution is required in the interpretation of these results due to the number of outcomes measured.
Behaviour change
Four trials reported some form of assessment of behaviour change (Bocca 2012; Stark 2011; Stark 2014; Taveras 2011).
Four trials measured physical activity, however different methods and outcomes were used (Appendix 7). Taveras 2011 found no substantial difference in change in number of hours per day of outdoor active playtime at the end of intervention (Analysis 1.21), and Bocca 2012 found no substantial difference in change in number of steps per day at 12 months' follow‐up (Analysis 1.22) Of the two trials evaluating LAUNCH (Stark 2011; Stark 2014), both reported change in average daily minutes of moderate and vigorous physical activity (Analysis 1.23; Analysis 1.24). Stark 2011 found no substantial difference in physical activity, and although data from Stark 2014 suggest a statistically significant effect in the LAUNCH clinic only group compared with control at 12 months' follow‐up, this result should be viewed with caution as the treatment effect was not statistically significant when computed using maximum likelihood estimation to account for missing data by Stark 2014.
One cluster RCT, Taveras 2011, reported a greater reduction in the number of servings per day of sugar‐sweetened drinks (MD ‐0.26 (95% CI ‐0.49 to ‐0.03); Analysis 1.25), but this was not statistically significant in an adjusted analysis (MD ‐0.22 (95% CI ‐0.52 to 0.08)). Similarly, there was no substantial difference in the increase in servings per day of fruits and vegetables (MD 0.06 (95% CI ‐0.21 to 0.33); Analysis 1.26), adjusted analysis: MD 0.12 (95% CI ‐0.17 to 0.42). However, we found a statistically significant difference in the reduction in hours per day of television and video viewing: MD ‐0.46 hrs (95% CI ‐0.70 to ‐0.22); Analysis 1.27), adjusted analysis: MD ‐0.36 hrs (95% CI ‐0.64 to ‐0.09). Analyses were adjusted for child age, sex, and race/ethnicity; parent education and overweight/obesity status at baseline; household income; and exact time elapsed from baseline to follow‐up visit.
Participant views of the intervention
Two trials reported the participants' views of the interventions. Taveras 2011 reported that 97% were “somewhat” or “very satisfied” with the High Five for Kids program, and that 91% would recommend the program to their family and friends. Using the Barrier to Treatment Participation Scale questionnaire, Stark 2011 reported no statistically significant difference between LAUNCH and comparator (paediatric counselling) on parent perceptions of treatment demands (11 for both groups) or relevance of treatment (11.3 versus 10.6, respectively). Parents in LAUNCH reported significantly greater stressors and obstacles compared to parents in the comparator group (33 ± 8.2 versus 25.6 ± 4.7, P = 0.038). Parents in LAUNCH and comparator were highly satisfied with treatment and did not differ substantially in their satisfaction ratings for information on nutrition (4.86 ± .38 versus 4.30 ± 1.25, P > 0.05) or physical activity (4.71 ± .49 versus 4.00 ± 1.25, P > 0.05), or in their satisfaction with ability to make recommended changes (4.26 ± .49 versus 4.20 ± 1.23, P > 0.05).
Parent‐child relationship or assessment of parenting
Two trials reported the Child Feeding Questionnaire (CFQ), a self report measure to assess parental beliefs, attitudes, and practices regarding child feeding (Stark 2011; Stark 2014) (Appendix 7). However, the trial authors report limited data. The CFQ contains 31 items, loading on seven factors. Four items relate to parental perception of child and parent weight, and concern about weight, which may elicit parental control in feeding. Pressure to eat scores were reduced by 0.9 and 0.6 at six months and by 0.6 and 0.3 at 12 months in the intervention and control groups, respectively (Stark 2011). Restriction to eat was described as "stable at approximately 4" with no statistically significant differences. Stark 2014 state "from baseline to months 6 and 12, CFQ restriction and pressure to eat remained relatively low (< 2.3) across all time points with no significant changes between groups".
Socioeconomic effects
No trials reported socioeconomic effects.
Diet interventions versus control
One three‐arm trial compared two diets (dairy rich and energy restricted) plus healthy lifestyle education with health lifestyle education alone (Kelishadi 2009). The intervention was of six months' duration, and follow‐up was three years from baseline, with 90.1%, 77.5%, and 90% follow‐up in the dairy‐rich, energy‐restricted, and control groups, respectively. We judged the trial to have a high risk of selective outcome bias and an unclear risk of selection bias, performance bias, detection bias, and other bias. The reported standard deviations appear very small and could possibly be standard errors.
Primary outcomes
Changes in body mass index (BMI) and body weight
For change in BMI z score, see Analysis 2.1. At the end of the intervention, BMI z score was reduced in all groups, however the reduction was greater with both the dairy‐rich diet (MD ‐0.10 units (95% CI ‐0.11 to ‐0.09)) and energy‐restricted diet (MD units ‐0.10 (95% CI ‐0.11 to ‐0.09)) than with control. At 12, 24, and 36 months' follow‐up, the difference between the dairy‐rich diet and control increased (MD units ‐0.20 (95% CI ‐0.21 to ‐0.19); MD ‐0.60 units (95% CI ‐0.61 to ‐0.59); MD ‐0.70 units (95% CI ‐0.71 to ‐0.69), respectively). In contrast, at 12 months' follow‐up, the MD between the energy‐restricted diet and control was 0.00 units (95% CI ‐0.01 to 0.01), and at 24 and 36 months' follow‐up, the outcome favoured control (MD 0.10 units (95% CI 0.09 to 0.11); MD units 0.10 (95% CI 0.09 to 0.11), respectively).
Adverse events
Adverse events were not reported.
Secondary outcomes
Health‐related quality of life and self esteem
Not reported.
All‐cause mortality
Not reported.
Morbidity
Not reported.
Anthropometric measures other than BMI
Reductions in waist circumference were greater with both the dairy‐rich (MD ‐0.30 cm (95% CI ‐0.39 to ‐0.21)) and energy‐restricted diet (MD ‐0.80 cm (95% CI ‐0.91 to ‐0.69)) at the end of the intervention (Analysis 2.2). At three years' follow‐up, only the dairy‐rich diet remained better on waist circumference than control (MD ‐0.70 cm (95% CI ‐0.84 to ‐0.56)), while the energy‐restricted diet had a worse outcome than the control group (MD 0.40 cm (95% CI 0.23 to 0.57)).
The dairy‐rich diet group had a greater reduction in percentage body fat than control at the end of the intervention (MD ‐2.00% (95% CI ‐2.18 to ‐1.82)), but this was not maintained at 24 months' follow‐up (Analysis 2.3). There were no substantial differences in percentage body fat between the energy‐restricted diet and control at either time point. Data at three years' follow‐up were not reported for this outcome.
Behaviour change
Kelishadi 2009 stated that "mean daily energy expenditure did not differ significantly by group at each time period throughout the study”, however data were presented in a figure only and could not be accurately estimated by review authors.
Participant views of the intervention
Participant views were not reported.
Parent‐child relationship or assessment of parenting
Not reported.
Socioeconomic effects
Socioeconomic effects were not reported.
Subgroup analyses
We did not perform subgroups analyses because there were not enough trials to estimate effects in various subgroups.
Sensitivity analyses
We did not perform any sensitivity analyses because there were not enough trials included in the analyses.
Assessment of reporting bias
We did not draw funnel plots due to limited number of trials per outcome (n = 7).
Ongoing studies
We found four ongoing RCTs. All are parallel RCTs, with estimated sample sizes of 28 to 240. For descriptions of the interventions, see Characteristics of ongoing studies; one trial focuses on parenting and parent lifestyle, and the other three trials are multicomponent interventions. The primary outcome includes BMI z score or BMI in all trials. The trial completion date ranges from November 2015 to August 2016, where reported.
Discusión
Resumen de los resultados principales
Esta revisión sistemática resumió siete ECA que examinaron el efecto del régimen dietético, la actividad física y las intervenciones conductuales para tratar el sobrepeso y la obesidad en los niños de edad preescolar hasta la edad de seis años. Solamente se incluyeron los ensayos incluidos con al menos una evaluación del resultado a los seis meses, con la intención de evaluar los efectos a más largo plazo de estas intervenciones. Las intervenciones y los comparadores variaron entre los ensayos incluidos y los ensayos se dividieron en dos grupos principales para facilitar la interpretación: intervenciones con múltiples componentes e intervenciones en el régimen dietético solamente. Los resultados evaluados también variaron entre los ensayos; la medida informada con más frecuencia fue la puntuación z del IMC, pero un ensayo informó el IMC solamente. Para permitir la comparación entre los ensayos, los datos de resultado se analizaron al final de la intervención (ya fuera a los seis o a los 12 meses) y a cada período de seguimiento informado. Cuatro ensayos tuvieron un riesgo incierto de sesgo de selección y la mayoría tuvo riesgo incierto o alto de sesgo de realización. Excepto dos ensayos, todos tuvieron un riesgo alto de sesgo de informe selectivo.
En general, las intervenciones con múltiples componentes fueron más exitosas que los comparadores para reducir el IMC y el peso corporal en los niños de edad preescolar y sus padres y los efectos se mantuvieron dos años después del comienzo de la intervención. Se encontraron mejorías en algunos aspectos de la calidad de vida relacionada con la salud, pero no en todos. Los ensayos midieron el cambio conductual de forma inconsistente y los efectos de las intervenciones fueron más ambiguos. Hubo una evaluación limitada de los puntos de vista de los participantes, la relación entre padres e hijos o la evaluación de la crianza; cuando se informaron, no hubo diferencias entre los grupos. Solamente un ensayo formuló observaciones sobre los eventos adversos y señaló que no se informaron.
Un ensayo de tres brazos encontró que las intervenciones dietéticas ricas en lácteos y con restricción energética dieron lugar a una mayor reducción del IMC que el comparador al final del período de intervención, pero solamente el régimen dietético rico en lácteos mantuvo la reducción a los 12 a 36 meses de seguimiento. Se realizó una evaluación limitada del cambio conductual; el gasto de energía diario medio no difirió significativamente entre los grupos. No se midieron la calidad de vida relacionada con la salud, los efectos adversos, los puntos de vista de los participantes y la crianza.
Varios resultados como la mortalidad por todas las causas, la morbilidad, la autoestima y los efectos socioeconómicos no se midieron en los ensayos incluidos.
Compleción y aplicabilidad general de las pruebas
Esta revisión sólo identificó siete ensayos que evaluaron los efectos del régimen dietético, la actividad física y las intervenciones conductuales a los seis meses o más.
Seis ensayos incluyeron intervenciones con múltiples componentes. Uno de estos ensayos todavía no se había informado completamente al momento de la redacción pero se incluirá en la próxima actualización de la revisión. La duración de las intervenciones y la duración del seguimiento variaron ligeramente entre estos ensayos, y en su mayoría los resultados se informaron a los 12 a 18 meses de seguimiento. Sólo un ensayo informó los resultados a los dos años de seguimiento. Los efectos a largo plazo de las intervenciones, por lo tanto, siguen siendo inciertas.
Un ensayo incluyó dos intervenciones de dieta diferentes. El régimen dietético rico en lácteos fue alto en cuajada y masa, que son productos lácteos tradicionales preparados y consumidos en Irán y pueden no ser relevantes para otros países. Los efectos beneficiosos del régimen dietético rico en lácteos encontrados en este ensayo necesitarían confirmarse en otros ensayos.
Pocos ensayos informaron los resultados secundarios de interés de la revisión y cuando se informaron hubo poco acuerdo en los tipos de medidas utilizadas, lo que dificultó la comparación.
Los resultados hasta la fecha indican que es probable que la magnitud del cambio en la puntuación z del IMC con las intervenciones con múltiples componentes sea clínicamente significativa en todos los períodos de seguimiento. Los datos disponibles en los adolescentes indican que un cambio de 0,25 o más se asocia con mejorías en la adiposidad y la salud metabólica, y que los cambios más grandes producen mayores efectos beneficiosos(Ford 2010). Aunque las poblaciones no son directamente comparables, proporcionan alguna indicación de la relevancia clínica.
Calidad de la evidencia
En general, la calidad de las pruebas fue baja; seis de los siete ensayos incluidos se consideraron con alto riesgo de sesgo en los criterios individuales del "Riesgo de sesgo" y solamente tres ensayos tuvieron bajo riesgo de sesgo de selección. Las evaluaciones GRADE de los resultados en esta revisión dieron lugar a que la calidad de los ensayos se disminuyera por el riesgo de sesgo y también por la imprecisión debido al escaso número de ensayos y los tamaños de la muestra pequeños. Esto hace que la interpretación general de los datos sea difícil.
Sesgos potenciales en el proceso de revisión
Para esta revisión se realizó una búsqueda exhaustiva a través de las bases de datos principales de las intervenciones para el sobrepeso y la obesidad en la niñez. Además, se examinaron las listas de referencias de revisiones sistemáticas. Cada ensayo incluido en la revisión se seleccionó de manera cuidadosa, se evaluó, se extrajeron los datos y dos revisores evaluaron la calidad para disminuir los sesgos potenciales en el proceso de revisión. No se tomaron decisiones acerca del análisis o la investigación de la heterogeneidad después de examinar los datos. Hubo diferencias entre los ensayos en las intervenciones administradas y los comparadores. Las comparaciones de esta revisión se dividieron en dos grupos, intervenciones con múltiples componentes e intervenciones dietéticas, para mejorar la comparabilidad de los ensayos dentro de los grupos. Esta decisión se tomó después de la revisión de las características de los ensayos incluidos, pero antes de que se examinaran los datos. Cuando faltaron datos relevantes para permitir la evaluación de la elegibilidad o en la etapa de extracción de los datos, los revisores establecieron contacto con los autores de los ensayo para obtener mayor información.
Acuerdos y desacuerdos con otros estudios o revisiones
Las revisiones sistemáticas anteriores identificaron una falta de ECA que evaluaran las intervenciones para el tratamiento del sobrepeso o la obesidad en los niños en edad preescolar (Bluford 2007; Bond 2009; Bond 2011; Oude Luttikhuis 2009). Desde que estas revisiones se realizaron, se han publicado siete ensayos y cuatro ensayos todavía están en curso. La revisión actual es la primera en sintetizar los estudios de investigación más actualizados y de alta calidad disponibles sobre la efectividad de las intervenciones para el tratamiento del sobrepeso o la obesidad en los niños en edad preescolar.
Study flow diagram.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials (blank cells indicate that the particular outcome was not investigated in some trials).
Risk of bias summary: review authors' judgements about each risk of bias item for each included study (blank cells indicate that the study did not report that particular outcome).
Comparison 1 Multicomponent intervention versus control, Outcome 1 Changes in BMI z score.
Comparison 1 Multicomponent intervention versus control, Outcome 2 Changes in BMI.
Comparison 1 Multicomponent intervention versus control, Outcome 3 Changes in % over BMI.
Comparison 1 Multicomponent intervention versus control, Outcome 4 Changes in BMI percentile.
Comparison 1 Multicomponent intervention versus control, Outcome 5 Changes in body weight.
Comparison 1 Multicomponent intervention versus control, Outcome 6 Changes in parental BMI.
Comparison 1 Multicomponent intervention versus control, Outcome 7 Changes in parental weight.
| Study | Domain | Intervention median (25th‐75th percentile), N | Control median (25th‐75th percentile), N | P value |
| 12 months follow‐up (8 months post intervention) | ||||
| Bocca 2012 | Total | 5.0 (‐1.8; 6.5), 20 | ‐4.5 (‐15.3; 4.0), 20 | P = 0.04 |
| Bocca 2012 | Physical | 8.3 (‐6.3; 16.7), 20 | ‐4.2 (‐12.5; 4.7), 20 | P = 0.03 |
| Bocca 2012 | Home | ‐4.2 (‐12.5; 4.7), 20 | 0.0 (‐15.0; 10.0), 20 | P = ns |
| Bocca 2012 | Emotional | 0.0 (‐3.6; 3.6), 20 | ‐3.6 (‐17.9; 10.7), 20 | P = ns |
| Bocca 2012 | Social | 1.8 (‐9.8; 7.1), 20 | ‐8.9 (‐14.3; 1.8), 20 | P = ns |
Comparison 1 Multicomponent intervention versus control, Outcome 8 Changes in health‐related quality of life: DUX 25.
| Study | Domain | Intervention median (25th;75th percentile), N | Control median (25th;75th percentile), N | P value |
| 12 months follow‐up (8 months post intervention) | ||||
| Bocca 2012 | Global health Physical functioning | 0.0 (‐12.5; 20.0), 20 0.0 (‐1.4; 12.5), 20 | 0.0 (‐25.0; 0.0), 20 0.0 (0.0; 9.7), 20 | P = ns P = ns |
| Bocca 2012 | Role functioning – Emotional/ behaviour Role functioning ‐ physical | 0.0 (0.0; 0.0), 20 0.0 (0.0; 0.0), 20 | 0.0 (0.0; 0.0), 20 0.0 (0.0; 0.0), 20 | P = ns P = ns |
| Bocca 2012 | Bodily pain General behaviour | 0.0 (‐5.0; 20.0), 20 0.0 (0.0; 25.0), 20 | 0.0 (‐17.5; 27.5), 20 0.0 (‐22.5; 25.0), 20 | P = ns P = ns |
| Bocca 2012 | Behaviour Mental health | 4.2 (‐9.4; 18.3), 20 0.0 (‐5.0; 10.0), 20 | ‐9.6 (‐16.7; 6.3), 20 ‐5.0 (‐15.0; 10.0), 20 | P = ns P = ns |
| Bocca 2012 | Self‐esteem General health | 12.5 (‐5.2; 29.2), 20 0.0 (‐3.3; 15.4), 20 | 4.2 (‐8.3; 12.5), 20 4.2 (‐16.0; 17.9), 20 | P = ns P = ns |
| Bocca 2012 | Change in health Parental impact ‐ emotional | 25.0 (0.0; 31.3), 20 0.0 (‐8.3; 8.3), 20 | 12.5 (0.0; 25.0), 20 ‐4.2 (‐14.6; 8.3), 20 | P = ns P = ns |
| Bocca 2012 | Parental impact ‐ time Family activities | 0.0 (‐11.1; 11.1), 20 ‐4.2 (‐13.5; 8.3), 20 | 0.0 (‐11.1; 0.0), 20 0.0 (‐8.3; 12.5), 20 | P = ns P = ns |
| Bocca 2012 | Family cohesion | 0.0 (‐15.0; 25.0), 20 | 0.0 (‐25.0; 22.5), 20 | P = ns P = ns |
Comparison 1 Multicomponent intervention versus control, Outcome 9 Changes in health‐related quality of life: CHQ‐PF50.
Comparison 1 Multicomponent intervention versus control, Outcome 10 Changes in health‐related quality of life: PEDsQL physical functioning.
Comparison 1 Multicomponent intervention versus control, Outcome 11 Changes in health‐related quality of life: PEDsQL total score.
Comparison 1 Multicomponent intervention versus control, Outcome 12 Changes in waist circumference.
Comparison 1 Multicomponent intervention versus control, Outcome 13 Changes in waist circumference z‐score.
Comparison 1 Multicomponent intervention versus control, Outcome 14 Changes in hip circumference.
Comparison 1 Multicomponent intervention versus control, Outcome 15 Changes in hip circumference z‐score.
Comparison 1 Multicomponent intervention versus control, Outcome 16 Changes in upper arm circumference.
Comparison 1 Multicomponent intervention versus control, Outcome 17 Changes in per cent body fat.
Comparison 1 Multicomponent intervention versus control, Outcome 18 Changes in fat‐free mass.
Comparison 1 Multicomponent intervention versus control, Outcome 19 Changes in visceral fat.
Comparison 1 Multicomponent intervention versus control, Outcome 20 Changes in subcutaneous fat.
Comparison 1 Multicomponent intervention versus control, Outcome 21 Changes in outdoor active play.
Comparison 1 Multicomponent intervention versus control, Outcome 22 Changes in steps.
Comparison 1 Multicomponent intervention versus control, Outcome 23 Changes in physical activity, moderate.
Comparison 1 Multicomponent intervention versus control, Outcome 24 Changes in physical activity, vigorous.
Comparison 1 Multicomponent intervention versus control, Outcome 25 Changes in sugar‐sweetened drinks.
Comparison 1 Multicomponent intervention versus control, Outcome 26 Changes in fruit and vegetable intake.
Comparison 1 Multicomponent intervention versus control, Outcome 27 Changes in TV and video viewing.
Comparison 2 Diet intervention versus control, Outcome 1 Changes in BMI z score.
Comparison 2 Diet intervention versus control, Outcome 2 Changes in waist circumference.
Comparison 2 Diet intervention versus control, Outcome 3 Changes in per cent body fat.
| Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children aged 0 to 6 years | ||||||
| Population: preschool children (aged 0 to 6 years) with overweight or obesity Settings: various Intervention: multicomponent interventions Comparison: usual care/enhanced usual care/information control/wait‐list control | ||||||
| Outcomes | Control | Multicomponent intervention | Relative effect | No of participants | Quality of the evidence | Comments |
| Changes in BMI and body weight a. BMI z scorea [units] Follow‐up: 12 to 18 months b. Weight [kg] Follow‐up: 12 to 18 months | a. The mean change in BMI z score ranged across control groups from ‐0.3 units to +0.4 units b. The mean change in weight ranged across control groups from +3.1 kg to +5.2 kg | b. The mean change in BMI z score in the intervention groups was 0.4 units lower (0.6 to 0.2 lower) b. The mean change in weight in the intervention group was 2.8 kg lower (4.4 to 1.2 lower) | ‐ | a. 202 (4) b. 202 (4) | a. ⊕⊕⊝⊝ b. ⊕⊕⊝⊝ | Lower units indicate more weight loss |
| Adverse events Follow‐up: 24 months | See comment | See comment | See comment | 88 (1) | ⊕⊝⊝⊝ | Only 1 trial (abstract only) reported on adverse events, stating no adverse events were observed |
| HrQoL and self esteem a. DUX 25 (Dutch Child AZL TNO Quality‐of‐Life tool: total score and 4 domains; scale 0 to 100; higher score indicates better HrQoL) Follow‐up: 12 months b. CHQ‐PF50 (Dutch edition of the Child Health Questionnaire Parent Form: 15 items; score 0 to 100; higher score indicates better HrQoL) Follow‐up: 12 months c. PedsQL (Pediatric Quality of Life Inventory, physical functioning subscale; higher score indicates better HrQoL) Follow‐up: 6 months/12 months d. PedsQL (total score) Follow‐up: 12 months | See comment | See comment | See comment | a. 40 (1) b. 40 (1) c. 17 (1) d. 16 (1) | a/b/c/d | No trials reported self esteem a. Change in median of the total score: +5 in the intervention group versus ‐5 in the control group; change in median of 1 of 4 domains (physical functioning): +8 in the intervention group versus ‐4 in the control group b. No statistically significant differences in any of the 15 items c. 6 months' change in mean: +9.5 units in the intervention group versus ‐1.7 units in the control group, data not reported for total score and 3 other subscales; 12 months' change in mean +13.8 units in the intervention group versus ‐2.7 units in the control group, data not reported for total score and 3 other subscales d. No substantial differences between multicomponent intervention and control group |
| All‐cause mortality | See comment | See comment | See comment | See comment | See comment | No trials reported all‐cause mortality |
| Morbidity | See comment | See comment | See comment | See comment | See comment | No trials reported morbidity |
| Parent‐child relationship or assessment of parenting | See comment | See comment | See comment | 44 (2) | ⊕⊝⊝⊝ | Limited data were reported, no substantial differences between intervention and control groups |
| Socioeconomic effects | See comment | See comment | See comment | See comment | See comment | No trials reported socioeconomic effects |
| BMI: body mass index; CI: confidence interval; HrQoL : health‐related quality of life | ||||||
| GRADE Working Group grades of evidence | ||||||
| a"A BMI z score or standard deviation score indicates how many units (of the standard deviation) a child's BMI is above or below the average BMI value for their age group and sex. For instance, a z score of 1.5 indicates that a child is 1.5 standard deviations above the average value, and a z score of ‐1.5 indicates a child is 1.5 standard deviations below the average value" (NOO NHS 2011). | ||||||
| Diet, physical activity, and behavioural interventions for the treatment of overweight or obesity in preschool children aged 0 to 6 years | ||||||
| Patient or population: preschool children (aged 0 to 6 years) with overweight or obesity Settings: obesity research clinic Intervention: dietary interventions + healthy lifestyle education Comparison: healthy lifestyle education | ||||||
| Outcomes | Healthy lifestyle education | Dietary intervention + healthy lifestyle education | Relative effect | No of participants | Quality of the evidence | Comments |
| Changes in BMI and body weight 1. Dairy‐rich diet a. BMI z score [units]a Follow‐up: 6 months b. BMI z score [units] Follow‐up: 36 months 2. Energy‐restricted diet a. BMI z score [units] Follow‐up: 6 months b. BMI z score [kg/m²] Follow‐up: 36 months | 1. Dairy‐rich diet a. The mean change in BMI z score was ‐0.5 units in the control group b. The mean change in BMI z score was +0.6 units in the control group 2. Energy‐restricted diet a. The mean change in BMI z score was ‐0.5 units in the control group b. The mean change in BMI z score was +0.6 units in the control group | 1. Dairy‐rich diet a. The mean change in BMI z score in the intervention group was b. The mean change in BMI z score in the intervention group was 2. Energy‐restricted diet a. The mean change in BMI z score in the intervention group was b. The mean change in BMI z score in the intervention group was | ‐ | 1. Dairy‐rich diet a. 59 (1) b. 52 (1) 2. Energy‐restricted diet a. 57 (1) b. 47 (1) | 1. Dairy‐rich diet a/b ⊕⊝⊝⊝ 2. Energy‐restricted diet a/b ⊕⊝⊝⊝ | Lower units indicate more weight loss 2 dietary interventions and 1 control compared in one 3‐arm randomised controlled trial (the number of participants in the control group was halved for the analysis and is shown here) |
| Adverse events | See comment | See comment | See comment | See comment | See comment | Not reported |
| Health‐related quality of life and self esteem | See comment | See comment | See comment | See comment | See comment | Not reported |
| All‐cause mortality | See comment | See comment | See comment | See comment | See comment | Not reported |
| Morbidity | See comment | See comment | See comment | See comment | See comment | Not reported |
| Parent‐child relationship or assessment of parenting | See comment | See comment | See comment | See comment | See comment | No trials reported parent‐child relationship or assessment of parenting |
| Socioeconomic effects | See comment | See comment | See comment | See comment | See comment | Not reported |
| *The basis for the assumed risk (e.g. the median control group risk across trials) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| a"A BMI z score or standard deviation score indicates how many units (of the standard deviation) a child's BMI is above or below the average BMI value for their age group and sex. For instance, a z score of 1.5 indicates that a child is 1.5 standard deviations above the average value, and a z score of ‐1.5 indicates a child is 1.5 standard deviations below the average value" (NOO NHS 2011). bDowngraded by three levels because of reporting bias, indirectness, and imprecision (one trial only with small number of participants); see Appendix 9. | ||||||
| Intervention(s) and comparator(s) | Sample sizea | Screened/eligible | Randomised | ITT | Analysed | Finishing study | Randomised finishing study | Follow‐up timeb | |
| Stark 2014 | I1: LAUNCH home visits | "Because of the small sample size, we were not powered to compare the two LAUNCH groups" | ‐/237 | 15 | 10 | 10 | 7 | 47 | 6 months/12 months |
| I2: LAUNCH clinic visits | 14 | 11 | 11 | 10 | 71 | ||||
| C: enhanced usual care | 13 | 12 | 12 | 11 | 85 | ||||
| total: | 42 | 33 | 33 | 28 | 67 | ||||
| Quattrin 2012 | I: family‐based intervention | In a mixed‐effect model a sample of 108 participants | 171/147 | 52 | 46 | 46 | 30 | 58 | 12 months/24 months |
| C: information control | 53 | 50 | 50 | 40 | 76 | ||||
| total: | 105 | 96 | 96 | 70 | 73 | ||||
| Bocca 2012 | I: multidisciplinary programme | ‐ | 78/75 | 40 | ‐ | 17 | 17 | 43 | 16 weeks/3 years |
| C: usual care | 35 | ‐ | 12 | 12 | 34 | ||||
| total: | 75 | ‐ | 29 | 29 | 39 | ||||
| Taveras 2011 | I: High Five for Kids: behavioural intervention | ‐ | 1486 attempted contact/361 contacted, pre‐eligible, willing | 271 (5 clusters) | ‐ | 253 | 253 | 93 | 12 months (end of intense phase; 2‐year data not reported) |
| C: usual care | 1007 attempted contact/267 contacted, pre‐eligible, willing | 204 (5 clusters) | ‐ | 192 | 192 | 94 | |||
| total: | 475 | 445 | 445 | 94 | |||||
| Stark 2011 | I: LAUNCH | ‐ | 4079/56 | 8 | ‐ | 7 (month 6 and 12) | 7 | 88 | 6 months/12 months |
| C: enhanced standard care | 10 | ‐ | 10 (month 6) 9 (month 12) | 9 | 90 | ||||
| total: | 18 | ‐ | 16 | 16 | 89 | ||||
| Lanigan 2010 | I: Trim Tots multicomponent intervention | ‐ | 105/105 | 49 | 49 | 49 | 21 | 43 | 6 months/2 years (6‐month follow‐up reported only) |
| C: wait‐list control | 39 | 39 | 39 | 21 | 54 | ||||
| total: | 88 | 88 | 88 | 42 | 48 | ||||
| Kelishadi 2009 | I1: dairy‐rich diet | 30 per group | ‐ | 40 | ‐ | ‐ | 36 | 90 | 6 months/3 years |
| I2: energy‐restricted diet | 40 | ‐ | ‐ | 31 | 78 | ||||
| C: control | 40 | ‐ | ‐ | 32 | 80 | ||||
| total: | 120 | 99 | 83 | ||||||
| Grand total | All interventions | 529 | 412 | ||||||
| All comparators | 394 | 317 | |||||||
| All interventions and comparators | 923 | 729 | |||||||
| aAccording to power calculation in study publication or report. ‐ denotes not reported C: comparator; I: intervention; ITT: intention‐to‐treat; LAUNCH: Learning about Activity and Understanding Nutrition for Child Health; N/A: not applicable | |||||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Changes in BMI z score Show forest plot | 5 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.1 End of intervention (6‐12 months) | 4 | 210 | Mean Difference (IV, Random, 95% CI) | ‐0.26 [‐0.37, ‐0.16] |
| 1.2 12‐18 months follow‐up (6‐8 months post intervention) | 4 | 202 | Mean Difference (IV, Random, 95% CI) | ‐0.38 [‐0.58, ‐0.19] |
| 1.3 24 months follow‐up (12 months post intervention) | 1 | 96 | Mean Difference (IV, Random, 95% CI) | ‐0.25 [‐0.40, ‐0.10] |
| 2 Changes in BMI Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.1 End of intervention (6‐12 months) | 1 | 64 | Mean Difference (IV, Random, 95% CI) | ‐0.40 [‐0.85, 0.05] |
| 2.2 12 months follow‐up (8 months post intervention) | 1 | 57 | Mean Difference (IV, Random, 95% CI) | ‐1.0 [‐1.79, ‐0.21] |
| 3 Changes in % over BMI Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 3.1 End of intervention (12 months) | 1 | Mean Difference (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 3.2 18 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 3.3 24 months follow‐up (12 months post intervention) | 1 | Mean Difference (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 4 Changes in BMI percentile Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 4.1 End of intervention (6 months) | 2 | 50 | Mean Difference (IV, Random, 95% CI) | ‐1.54 [‐2.82, ‐0.26] |
| 4.2 12 months follow‐up (6 months post intervention) | 2 | 49 | Mean Difference (IV, Random, 95% CI) | ‐3.47 [‐5.11, ‐1.82] |
| 5 Changes in body weight Show forest plot | 5 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 5.1 End of intervention (6‐12 months) | 4 | 210 | Mean Difference (IV, Random, 95% CI) | ‐1.18 [‐1.91, ‐0.45] |
| 5.2 12‐18 months follow‐up (6‐8 months post intervention) | 4 | 202 | Mean Difference (IV, Random, 95% CI) | ‐2.81 [‐4.39, ‐1.22] |
| 5.3 24 months follow‐up (12 months intervention) | 1 | 96 | Mean Difference (IV, Random, 95% CI) | ‐1.60 [‐2.42, ‐0.78] |
| 6 Changes in parental BMI Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 6.1 End of intervention (6‐12 months) | 2 | 113 | Mean Difference (IV, Random, 95% CI) | 0.00 [‐2.52, ‐1.48] |
| 6.2 12‐18 months follow‐up (6 months post intervention) | 2 | 112 | Mean Difference (IV, Random, 95% CI) | ‐2.08 [‐2.65, ‐1.51] |
| 6.3 24 months follow‐up (12 months post intervention) | 1 | 96 | Mean Difference (IV, Random, 95% CI) | ‐2.0 [‐2.57, ‐1.43] |
| 7 Changes in parental weight Show forest plot | 3 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 7.1 End of intervention (6‐12 months) | 3 | 146 | Mean Difference (IV, Random, 95% CI) | ‐4.69 [‐7.27, ‐2.11] |
| 7.2 12‐18 months follow‐up (6 months post intervention) | 2 | 49 | Mean Difference (IV, Random, 95% CI) | ‐5.14 [‐8.96, ‐1.33] |
| 7.3 24 months follow‐up (12 months post intervention) | 1 | 96 | Mean Difference (IV, Random, 95% CI) | ‐6.7 [‐8.42, ‐4.98] |
| 8 Changes in health‐related quality of life: DUX 25 Show forest plot | Other data | No numeric data | ||
| 8.1 12 months follow‐up (8 months post intervention) | Other data | No numeric data | ||
| 9 Changes in health‐related quality of life: CHQ‐PF50 Show forest plot | Other data | No numeric data | ||
| 9.1 12 months follow‐up (8 months post intervention) | Other data | No numeric data | ||
| 10 Changes in health‐related quality of life: PEDsQL physical functioning Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 10.1 End of intervention (6 months) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 10.2 12 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 11 Changes in health‐related quality of life: PEDsQL total score Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 11.1 End of intervention (6 months) | 1 | 28 | Mean Difference (IV, Random, 95% CI) | 4.35 [‐2.35, 11.06] |
| 11.2 12 months follow‐up (6 months post intervention) | 1 | 28 | Mean Difference (IV, Random, 95% CI) | 0.74 [‐5.80, 7.27] |
| 12 Changes in waist circumference Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 12.1 End of intervention (6 months) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 12.2 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 13 Changes in waist circumference z‐score Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 13.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 14 Changes in hip circumference Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 14.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 15 Changes in hip circumference z‐score Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 15.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 16 Changes in upper arm circumference Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 16.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 17 Changes in per cent body fat Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 17.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 18 Changes in fat‐free mass Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 18.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 19 Changes in visceral fat Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 19.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 20 Changes in subcutaneous fat Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 20.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 21 Changes in outdoor active play Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 21.1 End of intervention (12 months) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 22 Changes in steps Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 22.1 12 months follow‐up (8 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 23 Changes in physical activity, moderate Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 23.1 At end of intervention (6 months) | 2 | 48 | Mean Difference (IV, Random, 95% CI) | 6.57 [‐0.47, 13.61] |
| 23.2 12 months follow‐up (6 months post intervention) | 2 | 46 | Mean Difference (IV, Random, 95% CI) | 10.14 [‐3.80, 24.08] |
| 24 Changes in physical activity, vigorous Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 24.1 End of intervention (6 months) | 2 | 48 | Mean Difference (IV, Random, 95% CI) | 2.78 [‐1.30, 6.85] |
| 24.2 12 months follow‐up (6 months post intervention) | 2 | 47 | Mean Difference (IV, Random, 95% CI) | 7.40 [2.81, 12.00] |
| 25 Changes in sugar‐sweetened drinks Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 25.1 End of intervention (12 months) | 1 | Mean Difference (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 26 Changes in fruit and vegetable intake Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 26.1 End of intervention (12 months) | 1 | Mean Difference (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| 27 Changes in TV and video viewing Show forest plot | 1 | Mean Difference (IV, Fixed, 95% CI) | Totals not selected | |
| 27.1 End of intervention (12 months) | 1 | Mean Difference (IV, Fixed, 95% CI) | 0.0 [0.0, 0.0] | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Changes in BMI z score Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 1.1 Dairy rich: end of intervention (6 months) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.2 Energy restricted: end of intervention (6 months) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.3 Dairy rich: 12 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.4 Energy restricted: 12 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.5 Dairy rich: 24 months follow‐up (18 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.6 Energy restricted: 24 months follow‐up (18 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.7 Dairy rich: 36 months follow‐up (30 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 1.8 Energy restricted: 36 months follow‐up (30 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2 Changes in waist circumference Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 2.1 Dairy rich: end of intervention (6 months) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2.2 Energy restricted: end of intervention (6 months) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2.3 Dairy rich: 12 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2.4 Energy restricted: 12 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2.5 Dairy rich: 24 months follow‐up (18 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2.6 Energy restricted: 24 months follow‐up (18 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2.7 Dairy rich: 36 months follow‐up (30 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 2.8 Energy restricted: 36 months follow‐up (30 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 3 Changes in per cent body fat Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 3.1 Dairy rich: 12 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 3.2 Energy restricted: 12 months follow‐up (6 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 3.3 Dairy rich: 24 months follow‐up (18 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
| 3.4 Energy restricted: 24 months follow‐up (18 months post intervention) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | |
