Phase 3 N=130 Randomized Treatment

A Primary Care Behavioral Approach for Addressing Childhood Overweight

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00284557 ↗

Enrolled (actual)

130

Serious AEs

0.0%

Results posted

Jun 2012

Primary outcome: Primary: BMI Z-score(for Gender and Age)at 6-months — -0.129; 0.001 Z-score

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Group-based behavioral intervention (Behavioral)
Age: Pediatric · 7+ yrs
Sex: All
Sponsor: Emory University
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY BMI Z-score(for Gender and Age)at 6-months	-0.129; 0.001	—
PRIMARY BMI Z-score(for Gender and Age)at 12-months	-0.090; 0.001	—
SECONDARY Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and "Screen Time"	—	—

Summary

The purpose of this study is to determine whether participation in a group-based health education curriculum is superior to receipt of standardized health educational materials for children who are overweight or at risk for overweight with regard to achievement of a healthier body weight and improvement of key eating and physical activity behaviors.

Eligibility Criteria

Inclusion criteria included that the child must be:

Obese (BMI ≥ 95th percentile for age and gender) or at-risk for obesity (85th ≥ BMI > 95th percentile for age and gender);
African-American by parent report;
7-11 years of age;
Without any medical or psychological condition that would make weight loss or physical activity dangerous, or psychological disorders that would make adoption of health behaviors difficult;
Without any complications of obesity that indicate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy;
Together with the parent/caregiver indicate that they are ready to make changes in their eating and physical activity behaviors;
Have a parent/caregiver willing to participate.

Exclusion Criteria

As noted above, to participate in this study the child must not have a medical or psychological condition that would make weight loss or physical activity dangerous, psychological disorders that would make adoption of health behaviors difficult, or complications of obesity that necessitate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy. Examples of medical or psychological conditions that would render the child ineligible for this study include uncontrolled or poorly-controlled asthma or hypertension, bulimia, mental retardation or severe learning disability, as well as pseudotumor cerebri, sleep apnea, obesity hypoventilation syndrome, and slipped capital femoral epiphysis.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00284557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.