Clinical trial NCT00359957: Efficacy of Increasing Physical Activity to Reduce Children's Visceral Fat
Official title: Activity, Diet, and Visceral Adiposity: New Care Emerging (ADVANCE) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Keywords: Pediatric obesity
Physical activity
Visceral fat
Weight
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Seattle Children's Hospital
First posted: 2006-08-03
Enrollment: 29
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visceral adiposity
timeFrame: Change over 3-4 month period
Secondary outcomes:
measure: Subcutaneous abdominal adiposity
timeFrame: Change over 3-4 month period
measure: Total body fat
timeFrame: Change over 3-4 month period
measure: Body mass index
timeFrame: Change over 3-4 month period
measure: Physical activity
timeFrame: Change over 3-4 month period
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
affiliation: Children's Hospital and Regiona Medical Center, Seattle
name: Brian E Saelens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.