A Primary Care Behavioral Approach for Addressing Childhood Overweight

NCT00284557 | Completed Phase 3 Results

• 1 other identifier: 416-2005
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Keywords

Behavioral/Social; Obesity; Pediatrics; Preventive Medicine

Outcome Measures

Primary Outcomes (2)

• BMI Z-score(for Gender and Age)at 6-months

  The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.

  6-months post-intervention

• BMI Z-score(for Gender and Age)at 12-months

  The body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.

  12-months post-intervention

Secondary Outcomes (1)

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

  6- and 12-months post-intervention

Study Arms (2)

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

Health education materials only

ACTIVE COMPARATOR

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

Interventions

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.

Group-based behavioral intervention; Health education materials only

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

MeSH Terms

Conditions

Obesity; Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anne L. Dunlop, MD, MPH
• Organization: Emory University

amlang@emory.edu

404-712-8520

Study Officials

• Anne L Dunlop, MD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor

Study Record Dates

• First Submitted: January 30, 2006
• First Posted: February 1, 2006
• Study Start: January 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 11, 2012
• Results First Posted: June 28, 2012

Record last verified: 2012-06