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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Obesity

Treatments: Behavioral: Pediatric Obesity Intervention (STANDARD); Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00359957

NIH/NIDDK K23 DK60476

DK60476 (completed)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

29 participants in 2 patient groups

1

Experimental group

Description:

ADDED condition - behavioral intervention for modifying diet and physical activity, with greater emphasis on physical activity than the STANDARD condition

Treatment:

Behavioral: Pediatric Obesity Intervention + High Activity (ADDED)

2

Active Comparator group

Description:

STANDARD condition - behavioral intervention for modifying diet, with little emphasis on physical activity

Treatment:

Behavioral: Pediatric Obesity Intervention (STANDARD)