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Completed

NCT Number: NCT02343588

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

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.

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Key information

Conditions

Pediatric Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Health Lifestyles Interventions

Behavioral
  • 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

Primary outcomes

  1. Change in the prevalence of overweight and obesity

    Time frame: Baseline, Month 9

Secondary outcomes

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

    Time frame: Baseline, Month 9

  2. 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)

    Time frame: Baseline, Month 9

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

    Time frame: Baseline, Month 9

  4. 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)

    Time frame: Baseline, Month 9

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Central South University
  • Chongqing Medical University
  • Ningxia Medical University
  • Peking University
  • Shanghai Municipal Center for Disease Control and Prevention
  • Tianjin Medical University

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 22, 2015
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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