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Childhood Obesity Intervention Study

16 września 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

1392

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

8 lat do 10 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Brak interwencji: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Students' BMI change immediately after the intervention completion
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Students' BMI change one year after the intervention completion
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
The stage of change related to weight reduction behavior
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Peking University

Śledczy

  • Główny śledczy: Hai-Jun Wang, PhD, Peking University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

11 września 2018

Zakończenie podstawowe (Rzeczywisty)

30 czerwca 2019

Ukończenie studiów (Rzeczywisty)

29 kwietnia 2021

Daty rejestracji na studia

Pierwszy przesłany

3 września 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 września 2018

Pierwszy wysłany (Rzeczywisty)

11 września 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

17 września 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 września 2021

Ostatnia weryfikacja

1 września 2021

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2016YFC1300204

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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