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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Activity, Diet, and Visceral Adiposity: New Care Emerging (ADVANCE) Project

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Pediatric Obesity Intervention (STANDARD)
* Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition | Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)<br>* 14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)<br>|
| Active Comparator: 2<br>STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity | Behavioral: Pediatric Obesity Intervention (STANDARD)<br>* 14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visceral adiposity |  | Change over 3-4 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric obesity, Physical activity, Visceral fat, Weight