Clinical trial NCT02343588: A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity
Official title: Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: Chinese multi-centered school based obesity intervention
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Peking University
name: Central South University
name: Tianjin Medical University
name: Shanghai Municipal Center for Disease Control and Prevention
name: Chongqing Medical University
name: Ningxia Medical University
First posted: 2015-01-22
Enrollment: 70000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the prevalence of overweight and obesity
timeFrame: Baseline, Month 9
Secondary outcomes:
measure: Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)
timeFrame: Baseline, Month 9
measure: 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)
timeFrame: Baseline, Month 9
measure: Change in serum lipids and fasting glucose (fasting plasma glucose, fasting triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol)
timeFrame: Baseline, Month 9
measure: Change in physical fitness (standing-board jump, 50 meters speed run, 50 meters × 8 shuttle run (primary students) and run 800/1000 meters (secondary school students)
timeFrame: Baseline, Month 9
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: Jun MA, M.D
role: STUDY_CHAIR
affiliation: Central South University
name: Jiayou LUO, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University
name: Xin ZHANG, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Municipal Center for Disease Control and Prevention & Shanghai Institutes of Preventive Medicine
name: Chunyan LUO, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Chongqing Medical University
name: Hong WANG, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Ningxia Medical University
name: Haiping ZHAO, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaoning Health Supervision Bureau
name: Dehong PAN, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Jin JING, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.