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Childhood Obesity Intervention Study

16. září 2021 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

1392

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

8 let až 10 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.
Žádný zásah: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Students' BMI change immediately after the intervention completion
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Students' BMI change one year after the intervention completion
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The stage of change related to weight reduction behavior
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Peking University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Hai-Jun Wang, PhD, Peking University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

11. září 2018

Primární dokončení (Aktuální)

30. června 2019

Dokončení studie (Aktuální)

29. dubna 2021

Termíny zápisu do studia

První předloženo

3. září 2018

První předloženo, které splnilo kritéria kontroly kvality

7. září 2018

První zveřejněno (Aktuální)

11. září 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. září 2021

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. září 2021

Naposledy ověřeno

1. září 2021

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2016YFC1300204

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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