Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors

Pediatric Obesity Clinical Trial

Official title:

Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228434
• Other study ID #: IRB00001052-10081
• Status: Completed
• Phase: N/A
• First received: August 27, 2014
• Last updated: August 27, 2014
• Start date: May 2009

Study information

• Verified date: August 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The project aims at developing the tailored intervention strategy of childhood obesity based on monitoring physical activities with accelerometer and dietary behaviors using diary. It probably raise the passion of obese children to control weight, form healthy life style, be effective in sustaining weight loss and early prevent adulthood diseases.

Description:

The overweight and obese primary school students from 1-5 grades will be recruited according to "Body Mass Index Reference for Screening Overweight and Obesity in Chinese School-age Children". The participants with will be allocated with schools as the unit to four groups: tailored intervention based on monitoring physical activity and dietary behaviors, exercise intervention group based on the Happy 10 program, nutrition education intervention group. The three intervention groups received the designed interventions for the duration of 1 year. Before and after the intervention, we will carry out a questionnaire survey, a physical measurement, a fitness test, and a metabolic markers detection

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• Overweight and obese children from grade 1-5 primary schools

Exclusion Criteria:

• Students with any contraindication or physical diseases (heart, Lung, liver, kidney, other vital organs, endocrine diseases and drug side effects et al.) and psychological illnesses that may prevent them from participating in physical activity and eating a normal diet were excluded

Study Design

Allocation: Non-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:
• Monitoring and Tailored prescription

• Happy 10 program

• Specified nutrition education

• General Health Education

Locations

Country	Name	City	State
China	Insitute of Child and Adolescent Health, Peking University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Wang Jingjing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index		Baseline, 1-year post-intervention	No
Secondary	Change in obesity-related anthropometric measurements		Baseline, 1-year post-intervention	No
Secondary	Change of blood pressure		Baseline, 1-year post-intervention	No
Secondary	Change of biomarkers for disease risk		Baseline, 1-year post-intervention	No
Secondary	Change of attitude, knowledge, and behaviors on dietary and physical activity		Baseline, 1-year post-intervention	No