A FAMILY Program for Childhood Overweight and Obesity

Overweight and Obesity Clinical Trial

Official title:

A FAMILY Program for Childhood Overweight and Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773250
• Other study ID #: 201603121RIND
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children with overweight and obesity

Exclusion Criteria:

• Children with any other chronic or acute medical conditions

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Behavioral intervention
The intervention has an intensive phase and a maintenance phase.

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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