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

• ClinicalTrials.gov Identifier: NCT00359957
• Recruitment Status: Completed
• First Posted: August 3, 2006
• Last Update Posted: March 2, 2010
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: Seattle Children's Hospital
• Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Pediatric Obesity Intervention (STANDARD); Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Activity, Diet, and Visceral Adiposity: New Care Emerging (ADVANCE) Project
• Study Start Date: July 2006
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm	Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :

1. Visceral adiposity [ Time Frame: Change over 3-4 month period ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• 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

Locations

United States, Washington

Children's Hospital and Regional Medical Center

Seattle, Washington, United States, 98115

Sponsors and Collaborators

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

Seattle Children's Hospital

Investigators

• Principal Investigator: Brian E Saelens, Ph.D.; Children's Hospital and Regiona Medical Center, Seattle

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Brian Saelens, PhD, Children's Hospital and Regional Medical Center, Seattle
• ClinicalTrials.gov Identifier: NCT00359957
• Other Study ID Numbers: DK60476 (completed); NIH/NIDDK K23 DK60476
• First Posted: August 3, 2006
• Last Update Posted: March 2, 2010
• Last Verified: March 2010

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