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

Primary Purpose

Pediatric Obesity

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Monitoring and Tailored prescription

Happy 10 program

Specified nutrition education

General Health Education

About this trial

This is an interventional prevention trial for Pediatric Obesity focused on measuring Childhood obesity, intervention, effectiveness, comparison

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Insitute of Child and Adolescent Health, Peking University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Tailored intervention group

Happy 10 exercise group

Nutrition education group

Control group

Arm Description

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.

All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day.

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.

Receive no intervention

Outcomes

Primary Outcome Measures

Change in body mass index

Secondary Outcome Measures

Change in obesity-related anthropometric measurements

Change of blood pressure

Change of biomarkers for disease risk

Change of attitude, knowledge, and behaviors on dietary and physical activity

Full Information

NCT ID

NCT02228434

First Posted

August 27, 2014

Last Updated

August 27, 2014

Sponsor

Wang Jingjing

1. Study Identification

Unique Protocol Identification Number

NCT02228434

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Wang Jingjing

4. Oversight

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediatric Obesity

Keywords

Childhood obesity, intervention, effectiveness, comparison

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Non-Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tailored intervention group

Arm Type

Experimental

Arm Description

Arm Title

Happy 10 exercise group

Arm Type

Experimental

Arm Description

All the schools participating in this group were encouraged to take two Happy 10 sessions on each school day.

Arm Title

Nutrition education group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Receive no intervention

Intervention Type

Behavioral

Intervention Name(s)

Monitoring and Tailored prescription

Other Intervention Name(s)

ZhiJi accelerometer UX-02 as physical activity monitor

Intervention Type

Behavioral

Intervention Name(s)

Happy 10 program

Other Intervention Name(s)

happy 10 program developed by Center for Disease Control and Prevention, China

Intervention Type

Behavioral

Intervention Name(s)

Specified nutrition education

Intervention Type

Behavioral

Intervention Name(s)

General Health Education

Primary Outcome Measure Information:

Title

Change in body mass index

Time Frame