NCT02343588

Brief Summary

The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary=1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control=1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

January 7, 2015

Last Update Submit

January 22, 2015

Conditions

Pediatric Obesity

Keywords

Chinese multi-centered school based obesity intervention

Outcome Measures

Primary Outcomes (1)

  • Change in the prevalence of overweight and obesity

    Baseline, Month 9

Secondary Outcomes (4)

  • Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)

    Baseline, Month 9

  • Change in physical activity and dietary behaviors (Dietary, sedentary or physical activity behaviors and their determents, as measured by validated questionnaires (parent, children and school version)

    Baseline, Month 9

  • Change in serum lipids and fasting glucose (fasting plasma glucose, fasting triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol)

    Baseline, Month 9

  • Change in physical fitness (standing-board jump, 50 meters speed run, 50 meters Ă— 8 shuttle run (primary students) and run 800/1000 meters (secondary school students)

    Baseline, Month 9

Study Arms (2)

The Health Lifestyles Interventions

EXPERIMENTAL

1. Creating a supportive school, family and community environment; 2. Health lifestyles educational strategies; 3. Instruct and promote school physical education; 4. The monitoring and instruction of obesity related behaviors (focus group)

Behavioral: The Health Lifestyles Interventions

Receive no intervention

NO INTERVENTION

Usual practice

Interventions

The Health Lifestyles InterventionsBEHAVIORAL

1. Creating supportive school and family environment, whole intervention periods; 2. Health lifestyles educational strategies, 30min/week for education lessons and six times education activities; 3. Instruct and promote school physical education, whole intervention periods; 4. The monitoring and instruction of obesity related behaviors, once a week for physical activity and dietary behavioral log and once a month for parental monitor

The Health Lifestyles Interventions

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • grade of 1 to 5 in primary schools and grade of 6 to 8 and 10 to 11 in secondary schools.

You may not qualify if:

  • Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Guo P, Zhou Y, Zou Z, Chen Y, Jing J, Ma Y, Song Y, Ling W, Ma J, Zhu Y. Effects of School-Based Lifestyle Interventions on Cardiovascular Health in Chinese Children and Adolescents: A Post Hoc Analysis of a National Multicenter Study. J Am Heart Assoc. 2025 Jan 7;14(1):e037371. doi: 10.1161/JAHA.124.037371. Epub 2024 Dec 20.

    PMID: 39704211DERIVED

  • Guo P, Zhou Y, Zhu Y. Effects of a school-based lifestyle intervention on ideal cardiovascular health in Chinese children and adolescents: a national, multicentre, cluster-randomised controlled trial. Lancet Glob Health. 2023 Mar;11 Suppl 1:S14. doi: 10.1016/S2214-109X(23)00097-9.

    PMID: 36866471DERIVED

  • Neil-Sztramko SE, Caldwell H, Dobbins M. School-based physical activity programs for promoting physical activity and fitness in children and adolescents aged 6 to 18. Cochrane Database Syst Rev. 2021 Sep 23;9(9):CD007651. doi: 10.1002/14651858.CD007651.pub3.

    PMID: 34555181DERIVED

  • Dong Y, Zou Z, Wang H, Dong B, Hu P, Ma Y, Song Y, Ma J. National School-Based Health Lifestyles Intervention in Chinese Children and Adolescents on Obesity and Hypertension. Front Pediatr. 2021 May 28;9:615283. doi: 10.3389/fped.2021.615283. eCollection 2021.

    PMID: 34123956DERIVED

  • Diao H, Wang H, Yang L, Li T. The impacts of multiple obesity-related interventions on quality of life in children and adolescents: a randomized controlled trial. Health Qual Life Outcomes. 2020 Jul 6;18(1):213. doi: 10.1186/s12955-020-01459-0.

    PMID: 32631401DERIVED

  • Zou Z, Yang Z, Yang Z, Wang X, Gao D, Dong Y, Ma J, Ma Y. Association of high birth weight with overweight and obesity in Chinese students aged 6-18 years: a national, cross-sectional study in China. BMJ Open. 2019 May 22;9(5):e024532. doi: 10.1136/bmjopen-2018-024532.

    PMID: 31122966DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jun MA, M.D

    Peking University

    STUDY CHAIR

  • Jiayou LUO, M.D

    Central South University

    PRINCIPAL INVESTIGATOR

  • Xin ZHANG, M.D

    Tianjin Medical University

    PRINCIPAL INVESTIGATOR

  • Chunyan LUO, M.D

    Shanghai Municipal Center for Disease Control and Prevention & Shanghai Institutes of Preventive Medicine

    PRINCIPAL INVESTIGATOR

  • Hong WANG, M.D

    Chongqing Medical University

    PRINCIPAL INVESTIGATOR

  • Haiping ZHAO, M.D

    Ningxia Medical University

    PRINCIPAL INVESTIGATOR

  • Dehong PAN, M.D

    Liaoning Health Supervision Bureau

    PRINCIPAL INVESTIGATOR

  • Jin JING, M.D

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 22, 2015

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01