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| Sponsor: | Emory University |
|---|---|
| Collaborator: |
Centers for Disease Control and Prevention |
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00284557 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: Group-based behavioral intervention |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | Evaluation of a Primary Care-Based Behavioral Intervention for Improving Physical Activity and Nutrition Behaviors Among High-Risk African-American Youth |
| Estimated Enrollment: | 240 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group-based behavioral intervention: Experimental
The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
|
Behavioral: Group-based behavioral intervention
The group-based behavioral intervention targets eating behaviors, physical activity, and "screen time", and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter.
|
| Standard care: No Intervention |
In the United States, childhood obesity has tripled since 1970 such that 15% of those 6 to 19 years of age are obese, with higher observed prevalences for African-American and Hispanic children. Childhood obesity has significant short- and long-term health consequences. To avoid future morbidity, children who are obese or at risk for obesity must be identified and treated at an early stage. The primary care setting, where most children receive health care and where BMI should be tracked, may represent an early opportunity for identifying and treating childhood obesity. However, translational research is needed to test whether existing strategies for childhood obesity can be adapted for delivery via the primary care setting
The ultimate purpose of this work is to help overweight children, particularly those who are African-American, optimize their lifespan and quality of health through achievement of a healthier body mass index (BMI). Specific aims are to perform outcome and process evaluations to determine whether the intervention results in improvement in BMI percentile or habitual healthy eating and physical activity behaviors, and whether the intervention is feasible. The outcome evaluation component involves a randomized controlled trial, in which overweight children (BMI for age percentile >=95th) and children at risk for overweight (BMI for age percentile 85-94th)together with a parent/caregiver receive the primary care-based intervention or health education materials only. The intervention will focus on four main behavioral changes: decreasing consumption of key calorie-dense foods, increasing consumption of fruits and vegetables to ≥ 5 a day, reducing targeted sedentary behaviors to < 15 hrs per week, and increasing moderate and vigorous physical activity to 60 minutes or more daily. We will assess change in BMI percentile, number of servings of calorie-dense foods daily, and percent of time spent in sedentary and physical activities at 6-, 12-, and 18-months using mixed-model ANCOVA for repeated measures.
Eligibility| Ages Eligible for Study: | 7 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
(1) 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); (2) the child must be African-American; (3) the child must be 7-11 years of age; (4) the child must not have a medical or psychological condition that would make weight loss or physical activity dangerous, or psychological disorders that would make adoption of health behaviors difficult; (5) the child must not have complications of obesity that indicate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy; (6) the child and the parent/caregiver must each indicate that they are ready to make changes in their eating and physical activity behaviors; (7) a parent/caregiver must be 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.
Contacts and Locations
More Information
| Responsible Party: | Emory University ( Anne L. Dunlop, MD, MPH ) |
| Study ID Numbers: | 416-2005 |
| Study First Received: | January 30, 2006 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00284557 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Behavioral/Social Obesity Pediatrics Preventive Medicine |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |