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Completed

NCT Number: NCT00359957

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

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.

Completed

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Children's Hospital and Regional Medical Center

Seattle, Washington, 98115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Obesity Intervention (STANDARD)

Behavioral

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

Pediatric Obesity Intervention + High Activity (ADDED)

Behavioral

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

Primary outcomes

  1. Visceral adiposity

    Time frame: Change over 3-4 month period

Secondary outcomes

  1. Subcutaneous abdominal adiposity

    Time frame: Change over 3-4 month period

  2. Total body fat

    Time frame: Change over 3-4 month period

  3. Body mass index

    Time frame: Change over 3-4 month period

  4. Physical activity

    Time frame: Change over 3-4 month period

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • Seattle Children's Hospital

Registry information

Official study title

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

Acronym: ADVANCE

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 3, 2006
Registry last updated
Mar 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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