A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity

NCT ID: NCT02343588

Last Updated: 2015-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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The Health Lifestyles Interventions

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)

Group Type EXPERIMENTAL

The Health Lifestyles Interventions

Intervention Type BEHAVIORAL

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

Receive no intervention

Usual practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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The Health Lifestyles Interventions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

Tianjin Medical University

OTHER

Sponsor Role collaborator

Shanghai Municipal Center for Disease Control and Prevention

OTHER

Sponsor Role collaborator

Chongqing Medical University

OTHER

Sponsor Role collaborator

Ningxia Medical University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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CHEN Yajun

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun MA, M.D

Role: STUDY_CHAIR

Peking University

Jiayou LUO, M.D

Role: PRINCIPAL_INVESTIGATOR

Central South University

Xin ZHANG, M.D

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University

Chunyan LUO, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Hong WANG, M.D

Role: PRINCIPAL_INVESTIGATOR

Chongqing Medical University

Haiping ZHAO, M.D

Role: PRINCIPAL_INVESTIGATOR

Ningxia Medical University

Dehong PAN, M.D

Role: PRINCIPAL_INVESTIGATOR

Liaoning Health Supervision Bureau

Jin JING, M.D

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

References

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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.

Reference Type DERIVED
PMID: 39704211 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36866471 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34555181 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34123956 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32631401 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31122966 (View on PubMed)

Other Identifiers

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201202010

Identifier Type: -

Identifier Source: org_study_id

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