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

Pediatric Obesity Clinical Trial

Official title:

Development and Application of Appropriate Technology for Obesity Prevention and Control in Seven Centers in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02343588
• Other study ID #: 201202010
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: January 22, 2015
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70000
• Est. completion date: January 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• The Health Lifestyles Interventions
Creating supportive school and family environment, whole intervention periods; Health lifestyles educational strategies, 30min/week for education lessons and six times education activities; Instruct and promote school physical education, whole intervention periods; 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

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Sun Yat-sen University	Central South University, Chongqing Medical University, Ningxia Medical University, Peking University, Shanghai Municipal Center for Disease Control and Prevention, Tianjin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the prevalence of overweight and obesity		Baseline, Month 9	No
Secondary	Change in obesity related anthropometric measurements (waist circumference, hip circumference, blood pressure and skin fold thickness)		Baseline, Month 9	No
Secondary	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	No
Secondary	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	No
Secondary	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)		Baseline, Month 9	No