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

NCT ID: NCT00359957

Last Updated: 2010-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2007-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition

Group Type: EXPERIMENTAL

Pediatric Obesity Intervention + High Activity (ADDED)

Intervention Type: BEHAVIORAL

14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)

2

STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity

Group Type: ACTIVE_COMPARATOR

Pediatric Obesity Intervention (STANDARD)

Intervention Type: BEHAVIORAL

14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)

Interventions

Pediatric Obesity Intervention (STANDARD)

14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)

Intervention Type: BEHAVIORAL

Pediatric Obesity Intervention + High Activity (ADDED)

14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Children's Hospital and Regional Medical Center, Seattle

Principal Investigators

Brian E Saelens, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Regiona Medical Center, Seattle

Locations

Children's Hospital and Regional Medical Center

Seattle, Washington, United States

Countries

United States

References

Saelens BE, Grow HM, Stark LJ, Seeley RJ, Roehrig H. Efficacy of increasing physical activity to reduce children's visceral fat: a pilot randomized controlled trial. Int J Pediatr Obes. 2011 Apr;6(2):102-12. doi: 10.3109/17477166.2010.482157. Epub 2010 Jun 7.

Reference Type: DERIVED

PMID: 20528109 (View on PubMed)

Other Identifiers

NIH/NIDDK K23 DK60476

Identifier Type: -

Identifier Source: secondary_id

DK60476 (completed)

Identifier Type: -

Identifier Source: org_study_id