Back to resultsA FAMILY Program for Childhood Overweight and Obesity
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Behavioral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity
Eligibility Criteria
Inclusion Criteria:
- Children with overweight and obesity
Exclusion Criteria:
- Children with any other chronic or acute medical conditions
Sites / Locations
- National Taiwan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Behavioral Intervention
Control
Arm Description
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.
An active placebo control intervention was designed which did not apply evidence-based lifestyle recommendations effective in weight loss and focused on vegetable education.
Outcomes
Primary Outcome Measures
Child BMI-for-age z-score
Child BMI-for-age z-score will be computed based on the World Health Organization growth reference data for 5-19 years.
Secondary Outcome Measures
Child BMI
Child BMI will be calculated based on child weight and height.
Child percent body fat
Percent body fat will be estimated according to the skinfold thickness equations.
child sleep duration and sleep efficiency
Actigraphy-derived daily sleep duration and nocturnal sleep efficiency
Parental sleep quality
Pittsburgh Sleep Quality Index total scores
Full Information
NCT ID
NCT03773250
First Posted
October 23, 2018
Last Updated
August 8, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03773250
Brief Title
A FAMILY Program for Childhood Overweight and Obesity
Official Title
A FAMILY Program for Childhood Overweight and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
An active placebo control intervention was designed which did not apply evidence-based lifestyle recommendations effective in weight loss and focused on vegetable education.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral intervention
Intervention Description
The intervention has an intensive phase and a maintenance phase.
Primary Outcome Measure Information:
Title
Child BMI-for-age z-score
Description
Child BMI-for-age z-score will be computed based on the World Health Organization growth reference data for 5-19 years.
Time Frame
Change from baseline to 12 months post intervention
Secondary Outcome Measure Information:
Title
Child BMI
Description
Child BMI will be calculated based on child weight and height.
Time Frame
Change from baseline to 12 months post intervention
Title
Child percent body fat
Description
Percent body fat will be estimated according to the skinfold thickness equations.
Time Frame
Change from baseline to 12 months post intervention
Title
child sleep duration and sleep efficiency
Description
Actigraphy-derived daily sleep duration and nocturnal sleep efficiency
Time Frame
Change from baseline to 12 months post intervention
Title
Parental sleep quality
Description
Pittsburgh Sleep Quality Index total scores
Time Frame
Change from baseline to 12 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with overweight and obesity
Exclusion Criteria:
Children with any other chronic or acute medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Yu Tsai, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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A FAMILY Program for Childhood Overweight and Obesity
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