Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat

Phase 1

Completed

• Conditions: Obesity
• Interventions: Behavioral: Pediatric Obesity Intervention (STANDARD); Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)

• Registration Number: NCT00359957
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

The purpose of this trial is to examine whether adding greater physical activity to standard family-based behavioral pediatric obesity treatment decreases the amount of visceral fat among treated overweight children.

Detailed Description

Adult studies suggest that greater visceral fat confers more health risk than peripheral fat accumulation and that physical activity interventions (as part of general weight control interventions) are efficacious in reducing adults' visceral fat. There are few studies examining the impact of physical activity and/or general weight loss on children's visceral fat accumulation. The present study compares standard family-based behavioral weight control treatment for pediatric obesity (STANDARD) with standard treatment plus added emphasis on participants attaining high levels of physical activity (ADDED). Both conditions receive the same behavioral dietary intervention and therapeutic contact and attention. The ADDED condition receives the recommendation and goal to be active at least 90 minutes per day, with behavioral strategies targeting increasing and sustaining these high levels of physical activity.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-01
• Study First Submitted QC: 2006-08-01
• Study First Posted: 2006-08-03
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-01
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• 7-12 years old
• >85th percentile BMI
• have at least one parent with a BMI>25
• able to engage in at least moderate intensity physical activity
• child and parent willing and able to participate in behavioral treatment
• English-speaking

Exclusion Criteria

• child or parent already enrolled in another weight control program
• child or parent with a medical condition known to affect weight or growth
• child or parent with significant mental illness that would interfere with engaging in treatment
• child or parent with a current or past diagnosed eating disorder
• child or parent currently taking any medication that affects weight or growth
• child who is more than 120% above their median BMI for age and gender

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Pediatric Obesity Intervention (STANDARD)	STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity
1	Pediatric Obesity Intervention + High Activity (ADDED)	ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition

Primary Outcome Measures

Name	Time	Method
Visceral adiposity	Change over 3-4 month period

Secondary Outcome Measures

Name	Time	Method
Subcutaneous abdominal adiposity	Change over 3-4 month period
Total body fat	Change over 3-4 month period
Body mass index	Change over 3-4 month period
Physical activity	Change over 3-4 month period

Trial Locations

Locations (1)

Children's Hospital and Regional Medical Center; 🇺🇸 Seattle, Washington, United States