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Childhood Obesity Intervention Study

16 de setembro de 2021 atualizado por: Hai-Jun Wang, Peking University

A School-based Multicomponent Intervention Study for Preventing Excessive Weight Gain Among Primary School Students

Globally, childhood overweight and obesity is a public health problem. Although the rising trend in children's body mass index (BMI) has plateaued in some high-income countries, it has accelerated in low- and middle-income countries. It is especially true amongst Chinese children with the annual increase rate of obesity during 2010-2014 greater than any other periods from 1985 to 2010.

With the dramatic economic development in China, children are now growing up in an increasingly 'obesogenic' environment. For example, the availability and ubiquity of computers and smart phones promote sedentary time, and access to energy dense food and sugar sweetened beverages is now widespread. Effective childhood obesity intervention is urgently needed in China. Although over 20 intervention studies for overweight/obesity among children and adolescents have been conducted in China since the 1990s, most of them had moderate or serious methodological weaknesses. For example, they did not report the number of students, schools or districts initially approached to participate, raising the possibility of selection and recruitment bias. Additionally, although they stated the allocation of intervention and control were randomized, no description of the method of randomization was reported.

Given the relative lack of high-quality interventions for childhood overweight/obesity, the investigators designed a cluster randomized controlled trial to assess the effectiveness of a multicomponent one-academic-year intervention among 24 primary schools (approximately 1200 students) in the eastern (Beijing), middle (Shanxi) and western (Xinjiang) part of China.

The study aims to identify: 1) whether the school-based intervention will be effective for preventing excessive weight gain among children; 2) whether the intervention will be beneficial for improving healthy eating, physical activity and reducing sedentary behaviors among children.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

1392

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
      • Beijing, China
        • Department of Maternal and Child Health, School of Public Health, Peking University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

8 anos a 10 anos (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

1. Eligibility criteria for schools The trial recruited a total of 24 schools. A convenience sample of 8 schools were selected from Beijing, Shanxi (Changzhi City) and Xinjiang (Urumqi City) respectively.

  1. Inclusion Criteria for schools:

    • school leader agreeing to implement this intervention; requiring school teachers who can implement this intervention (e.g. school doctors, physical education teachers, physical education teachers, etc.); having at least 50 children from Grade 4 (at the start of the intervention) per school;having a even number of schools within each district.

  2. Exclusion Criteria for schools:

    • boarding schools;schools solely for children with special skills; schools of minor ethnic groups; similar programme (focus on weight gain prevention) would be conducted in schools during the study period; schools having a cancelling or relocation plan during the study period.

      2. Eligibility criteria for classes One class per school will be selected if the estimated number of students enrolled in the programme is no less than 40 within the selected class; two classes per school will be selected if the estimated number of students enrolled in the programme is less than 40 within the selected class.

      3. Eligibility criteria for students Eligible children will be those whose primary caregivers will provide written consent to participate the study. After collecting students' medical history from their parents, we will exclude individuals suffering from or having a history of any cardiovascular and metabolic diseases, asthma and disabilities that limit their ability to perform physical activity.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: multicomponent intervention

Schools in the intervention arm will receive a multicomponent intervention at the school-, parent- and student-level, with a mobile application to promote the collaboration between investigators, school teachers, parents and students.

The school-level intervention elements will include school policies and health education for teachers.

The parent-level intervention elements will include health education for parents and promoting students' physical activity at home.

The student-level intervention elements will include health education for students, promoting students' physical activity in school and monthly monitoring of weight and height.
Comportamental: a multicomponent intervention
  1. School-level policies Students will not be allowed to drink sugar-sweetened beverage or eat unhealthy snacks in schools and drinking water will be advocated.
  2. Monitoring of students' weight and height Students will be monitored their weight and height monthly.
  3. Promotion of physical activity Students will be required to perform at least 60 minutes of moderate to vigorous physical activity each day in school and increase their physical activity outside school (reaching 30 minutes per weekday and one hour per weekend day).
  4. Health education activities Health education activities will be provided for students (10 sessions, 40 minutes per session, 2-3 weeks once), parents and school teachers.
  5. The mobile application The mobile application will disseminate health education knowledge among students, parents and teachers, monitor and provide feedback of students' BMI status and diet and physical activity behaviors.
Sem intervenção: usual-care control
Schools assigned to the control group will have usual education provision throughout their participation in the trial, and after finishing the study they will be offered the health education package, policy suggestion and materials as the schools in the multicomponent intervention group.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Students' BMI change immediately after the intervention completion
Prazo: at end of the 8-month intervention
the difference between arms in the change of students' BMI immediately after the intervention completion
at end of the 8-month intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Students' BMI change one year after the intervention completion
Prazo: at 15 months following the end of the intervention
the difference between arms in the change of students' BMI one year after the intervention completion
at 15 months following the end of the intervention
Students' BMI-Z change
Prazo: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
use BMI to calculate BMI-Z score based on WHO growth chart
1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of prevalence of childhood overweight/obesity
Prazo: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
define childhood overweight or obesity based on international BMI percentile criteria (IOTF)
1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of incidence of childhood overweight/obesity
Prazo: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
define childhood overweight or obesity based on international BMI percentile criteria (IOTF)
1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of students' waist circumference
Prazo: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure waist circumference
1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of students' waist-to-hip circumference ratio
Prazo: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure waist circumference and hip circumference to calculate waist-to-hip circumference ratio
1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of both systolic and diastolic blood pressures among students
Prazo: 1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
measure systolic and diastolic blood pressure by using electronic sphygmomanometer
1. at end of the 8-month intervention; 2. at 15 months following the end of the intervention
The change of body fat percentage among students
Prazo: at end of the 8-month intervention
measure body fat percentage by bioelectrical impedance analysis
at end of the 8-month intervention
The change of one-minute rope skipping test outcomes among students
Prazo: at end of the 8-month intervention
count the number of one-minute rope skipping
at end of the 8-month intervention
The change of one-minute sit-up test outcomes among students
Prazo: at end of the 8-month intervention
count the number of one-minute sit-up test
at end of the 8-month intervention
The change of endurance run (50 metre*8) test outcomes among students
Prazo: at end of the 8-month intervention
record the time of endurance run (50 metre*8)
at end of the 8-month intervention
The change of standing long jump test outcomes among students
Prazo: at end of the 8-month intervention
measure the distance of standing long jump
at end of the 8-month intervention
The change of students' knowledge related to energy balance
Prazo: at end of the 8-month intervention
We will use a self-designed questionnaire including 8 items to assess the change of students' knowledge related to energy balance. For example, we will ask students, "Is it right that drinking sugar-sweetened beverage cannot substitute drinking water." Three choices will be provided (Right; Wrong; Not clear).
at end of the 8-month intervention
The change of students'duration of moderate-to-vigorous physical activity
Prazo: at end of the 8-month intervention
Questions were designed based on a validated 7-day physical activity questionnaire. Kappa values for a two-week test-retest ranged from 0.46 to 0.79.
at end of the 8-month intervention
The change of students' eating behavior
Prazo: at end of the 8-month intervention
We will use a parent-rated "Children Eating Behavior Questionnaire" (CEBQ) to assess students' eating behaviors, including responsiveness to food, enjoyment of food etc. This 35-item instrument has been shown relatively good reliability.
at end of the 8-month intervention
The change of students' sedentary behavior
Prazo: at end of the 8-month intervention
We will use a self-designed questionnaire to ask the average duration of doing homework, watching television and playing electronic devices per day during the last week, respectively.
at end of the 8-month intervention
The change of school-level policies for childhood overweight/obesity
Prazo: at end of the 8-month intervention
We will use a self-designed questionnaire to measure school obesity-related policies involving school administration, health education, management of overweight or obesity, communication with the families of students and school lunch.
at end of the 8-month intervention

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
The stage of change related to weight reduction behavior
Prazo: at end of the 8-month intervention
We will use two items to assess it. First, we will ask "Have you taken action to reduce your weight during the last three months?" Yes/no choices will be provided. And then, we will ask "Do you intend to reduce your weight currently?" This item will be provided 5 choices from "completely not intend" to "intend very much".
at end of the 8-month intervention

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Peking University

Investigadores

  • Investigador principal: Hai-Jun Wang, PhD, Peking University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de setembro de 2018

Conclusão Primária (Real)

30 de junho de 2019

Conclusão do estudo (Real)

29 de abril de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

3 de setembro de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de setembro de 2018

Primeira postagem (Real)

11 de setembro de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de setembro de 2021

Última verificação

1 de setembro de 2021

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2016YFC1300204

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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