A FAMILY Program for Childhood Overweight and Obesity

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Behavioral intervention

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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with overweight and obesity

Exclusion Criteria:

• Children with any other chronic or acute medical conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): July 31, 2021
• Study Completion (ACTUAL): July 31, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (ACTUAL): December 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: 201603121RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No