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A FAMILY Program for Childhood Overweight and Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03773250
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : January 2, 2020
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Childhood overweight and obesity is a health problem with lifelong implications related to diabetes, hypertension, cardiovascular disease, psychological disorders as well as other chronic conditions.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Behavioral intervention Not Applicable

Detailed Description:
In Taiwan, the nationwide prevalence of overweight and obesity among school-age children aged 7 to 11 years has also increased over the past years. Sleep and weight are intricately related. School-age children requires at least 10 hours of sleep per night but children in Asian countries are on average obtaining shorter sleep than children in Caucasian countries.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A FAMILY Program for Childhood Overweight and Obesity
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
Experimental: Behavioral Intervention
Children and families in the intervention group will received the FAMILY program developed according to evidence-based guidelines.The intervention content regarding healthy sleep will emphasize the importance of having a consistent sleep schedule, establishing a regular bedtime routine, and creating an environment only for sleeping. The physical activity content will emphasize at least 60 minutes/day of moderate-to-vigorous intensity physical activity, reduction of sedentary behavior, and screen time limited to 2 hours/day. The nutrition content will emphasis the replacement of sugar-sweetened beverages, increased fruit and vegetable as well as water intake, consumption of regular meals, and reduction of discretionary food groups.
Behavioral: Behavioral intervention
The intervention has an intensive phase and a maintenance phase.

No Intervention: Control
No intervention will be provided.

Primary Outcome Measures :
  1. Body mass index [ Time Frame: Change from baseline to 6 months post intervention ]
    Body mass index will be calculated using children's height and weight.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Children with overweight and obesity

Exclusion Criteria:

  • Children with any other chronic or acute medical conditions

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 identifier (NCT number): NCT03773250

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Contact: Shao-Yu Tsai, PhD +886-23123456 ext 88904
Contact: Ching-Chia Hsieh, BS

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National Taiwan University Recruiting
Taipei, Taiwan
Contact: Shao-Yu Tsai, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Shao-Yu Tsai, PhD National Taiwan University
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Responsible Party: National Taiwan University Hospital Identifier: NCT03773250    
Other Study ID Numbers: 201603121RIND
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight