A FAMILY Program for Childhood Overweight and Obesity

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Behavioral intervention

• Registration Number: NCT03773250
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-12
• Status Verified: 2021-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Children with overweight and obesity

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Exclusion Criteria

• Children with any other chronic or acute medical conditions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Intervention	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.
Control	Behavioral intervention	An active placebo control intervention was designed which did not apply evidence-based lifestyle recommendations effective in weight loss and focused on vegetable education.

Primary Outcome Measures

Name	Time	Method
Child BMI-for-age z-score	Change from baseline to 12 months post intervention	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

Name	Time	Method
Child BMI	Change from baseline to 12 months post intervention	Child BMI will be calculated based on child weight and height.
child sleep duration and sleep efficiency	Change from baseline to 12 months post intervention	Actigraphy-derived daily sleep duration and nocturnal sleep efficiency
Parental sleep quality	Change from baseline to 12 months post intervention	Pittsburgh Sleep Quality Index total scores
Child percent body fat	Change from baseline to 12 months post intervention	Percent body fat will be estimated according to the skinfold thickness equations.

Trial Locations

Locations (1)

National Taiwan University; 🇨🇳 Taipei, Taiwan