A FAMILY Program for Childhood Overweight and Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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A FAMILY Program for Childhood Overweight and Obesity

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Behavioral intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with overweight and obesity Exclusion Criteria: Children with any other chronic or acute medical conditions

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention<br>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<br>* The intervention has an intensive phase and a maintenance phase.<br>|
| Other: Control<br>An active placebo control intervention was designed which did not apply evidence-based lifestyle recommendations effective in weight loss and focused on vegetable education. | Behavioral: Behavioral intervention<br>* The intervention has an intensive phase and a maintenance phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 12 months post intervention | 

Secondary Outcome Measures

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