A FAMILY Program for Childhood Overweight and Obesity

NCT03773250 | Completed

• 1 other identifier: 201603121RIND
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Child BMI

  Change from baseline to 12 months post intervention

• Child percent body fat

  Change from baseline to 12 months post intervention

• child sleep duration and sleep efficiency

  Change from baseline to 12 months post intervention

• Parental sleep quality

  Change from baseline to 12 months post intervention

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Behavioral intervention BEHAVIORAL

The intervention has an intensive phase and a maintenance phase.

Behavioral Intervention; Control

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with overweight and obesity

You may not qualify if:

• Children with any other chronic or acute medical conditions

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shao-Yu Tsai, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: December 12, 2018
• Study Start: August 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: August 11, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)