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

This study has been completed.
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00359957
First received: August 1, 2006
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Obesity
Behavioral: Pediatric Obesity Intervention (STANDARD)
Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Activity, Diet, and Visceral Adiposity: New Care Emerging (ADVANCE) Project

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Visceral adiposity [ Time Frame: Change over 3-4 month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subcutaneous abdominal adiposity [ Time Frame: Change over 3-4 month period ] [ Designated as safety issue: No ]
  • Total body fat [ Time Frame: Change over 3-4 month period ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: Change over 3-4 month period ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Change over 3-4 month period ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: July 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
14 weekly behavioral intervention visits with parent and child; individual family sessions (25-30 minutes) and separate parent and child groups (40 minutes)
Active Comparator: 2
STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity
Behavioral: 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)

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

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359957

Locations
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Brian E Saelens, Ph.D. Children's Hospital and Regiona Medical Center, Seattle
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Saelens, PhD, Children's Hospital and Regional Medical Center, Seattle
ClinicalTrials.gov Identifier: NCT00359957     History of Changes
Other Study ID Numbers: DK60476 (completed), NIH/NIDDK K23 DK60476
Study First Received: August 1, 2006
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Pediatric obesity
Physical activity
Visceral fat
Weight

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014