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

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ClinicalTrials.gov Identifier: NCT02228434
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Wang Jingjing, Peking University

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: Monitoring and Tailored prescription Behavioral: Happy 10 program Behavioral: Specified nutrition education Behavioral: General Health Education Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study on the Tailored Intervention Strategy of Childhood Obesity Based on Monitoring Physical Activities and Dietary Behaviors
Study Start Date : May 2009
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine


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: Monitoring and Tailored prescription
Other Name: ZhiJi accelerometer UX-02 as physical activity monitor

Behavioral: General Health Education
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: Happy 10 program
Other Name: happy 10 program developed by Center for Disease Control and Prevention, China

Behavioral: General Health Education
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: Specified nutrition education
Behavioral: General Health Education
No Intervention: Control group
Receive no intervention



Primary Outcome Measures :
  1. Change in body mass index [ Time Frame: Baseline, 1-year post-intervention ]

Secondary Outcome Measures :
  1. Change in obesity-related anthropometric measurements [ Time Frame: Baseline, 1-year post-intervention ]
  2. Change of blood pressure [ Time Frame: Baseline, 1-year post-intervention ]
  3. Change of biomarkers for disease risk [ Time Frame: Baseline, 1-year post-intervention ]
  4. Change of attitude, knowledge, and behaviors on dietary and physical activity [ Time Frame: Baseline, 1-year post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228434


Locations
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China
Insitute of Child and Adolescent Health, Peking University
Beijing, China, 100191
Sponsors and Collaborators
Wang Jingjing

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wang Jingjing, Institute of Child and Adolescent Health, Peking University
ClinicalTrials.gov Identifier: NCT02228434     History of Changes
Other Study ID Numbers: IRB00001052-10081
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by Wang Jingjing, Peking University:
Childhood obesity, intervention, effectiveness, comparison
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms