A Primary Care Behavioral Approach for Addressing Childhood Overweight

• ClinicalTrials.gov Identifier: NCT00284557
• Recruitment Status: Completed
• First Posted: February 1, 2006
• Results First Posted: June 28, 2012
• Last Update Posted: July 11, 2012
• Sponsor: Emory University
• Collaborator: Centers for Disease Control and Prevention
• Information provided by (Responsible Party): Anne Lang Dunlop, MD, MPH, Emory University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Group-based behavioral intervention	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of a Primary Care-Based Behavioral Intervention for Improving Physical Activity and Nutrition Behaviors Among High-Risk African-American Youth
• Study Start Date: January 2006
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	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.
Active Comparator: Health education materials only; Those allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.	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.

Outcome Measures

Primary Outcome Measures :

1. BMI Z-score(for Gender and Age)at 6-months [ Time Frame: 6-months post-intervention ]
   The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
2. BMI Z-score(for Gender and Age)at 12-months [ Time Frame: 12-months post-intervention ]
   The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.

Secondary Outcome Measures :

1. Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and "Screen Time" [ Time Frame: 6- and 12-months post-intervention ]

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion criteria included that the child must be:

1. Obese (BMI ≥ 95th percentile for age and gender) or at-risk for obesity (85th ≥ BMI > 95th percentile for age and gender);
2. African-American by parent report;
3. 7-11 years of age;
4. 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;
5. Without any complications of obesity that indicate prompt referral to a pediatric obesity treatment center for more aggressive weight loss therapy;
6. Together with the parent/caregiver indicate that they are ready to make changes in their eating and physical activity behaviors;
7. 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.

Contacts and Locations

Sponsors and Collaborators

Emory University

Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Anne L Dunlop, MD, MPH; Emory University

More Information

• Responsible Party: Anne Lang Dunlop, MD, MPH, Asst Professor, Emory University
• ClinicalTrials.gov Identifier: NCT00284557
• Other Study ID Numbers: 416-2005
• First Posted: February 1, 2006
• Results First Posted: June 28, 2012
• Last Update Posted: July 11, 2012
• Last Verified: June 2012

Keywords provided by Anne Lang Dunlop, MD, MPH, Emory University:

Behavioral/Social; Obesity; Pediatrics; Preventive Medicine

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight