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Completed

NCT Number: NCT00284557

A Primary Care Behavioral Approach for Addressing Childhood Overweight

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.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group-based behavioral intervention

Behavioral

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.

Primary outcomes

  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 outcomes

  1. Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and "Screen Time"

    Time frame: 6- and 12-months post-intervention

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Evaluation of a Primary Care-Based Behavioral Intervention for Improving Physical Activity and Nutrition Behaviors Among High-Risk African-American Youth

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Feb 1, 2006
Registry last updated
Jul 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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