A FAMILY Program for Childhood Overweight and Obesity

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03773250

Collaborator

(none)

164

Enrollment

Location

Arms

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: Behavioral intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

164 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 :

Aug 1, 2018

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

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.
Other: Control 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 The intervention has an intensive phase and a maintenance phase.

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.

Other: Control

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

The intervention has an intensive phase and a maintenance phase.

Outcome Measures

Primary Outcome Measures

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

Child BMI [Change from baseline to 12 months post intervention]
Child BMI will be calculated based on child weight and height.
Child percent body fat [Change from baseline to 12 months post intervention]
Percent body fat will be estimated according to the skinfold thickness equations.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 8 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Shao-Yu Tsai, PhD, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT03773250

Other Study ID Numbers:

201603121RIND

First Posted:

Dec 12, 2018

Last Update Posted:

Aug 11, 2022

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Pediatric Obesity

Overweight

Study Results

No Results Posted as of Aug 11, 2022