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

August 27, 2014 updated by: Wang Jingjing
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100191
        • Insitute of Child and Adolescent Health, Peking University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored intervention group

For the monitoring session, physical activity was assessed by accelerometer and dietary was assessed by diary. Based on the monitoring information, the individual tailored prescription, including the normative feedback and process feedback, were formed and delivered to children and parents. Children were encouraged to modify the behaviors according to the prescription.

Then, next monitoring circle was followed. In total, 7 monitoring round were completed.
Behavioral: General Health Education
Behavioral: Monitoring and Tailored prescription
Other Names:
  • ZhiJi accelerometer UX-02 as physical activity monitor
Experimental: Happy 10 exercise group
All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day.
Behavioral: General Health Education
Behavioral: Happy 10 program
Other Names:
  • happy 10 program developed by Center for Disease Control and Prevention, China
Experimental: Nutrition education group
The nutrition intervention was mainly conducted based on the nutrition knowledge through health education lectures given by researchers. The lectures were given for eight times to students and twice to parents. Each lecture session lasted no less than 40 min.
Behavioral: General Health Education
Behavioral: Specified nutrition education
No Intervention: Control group
Receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body mass index
Time Frame: Baseline, 1-year post-intervention
Baseline, 1-year post-intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in obesity-related anthropometric measurements
Time Frame: Baseline, 1-year post-intervention
Baseline, 1-year post-intervention
Change of blood pressure
Time Frame: Baseline, 1-year post-intervention
Baseline, 1-year post-intervention
Change of biomarkers for disease risk
Time Frame: Baseline, 1-year post-intervention
Baseline, 1-year post-intervention
Change of attitude, knowledge, and behaviors on dietary and physical activity
Time Frame: Baseline, 1-year post-intervention
Baseline, 1-year post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wang Jingjing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00001052-10081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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