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A Primary Care Behavioral Approach for Addressing Childhood Overweight

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00284557
Enrollment
130
Registered
2006-02-01
Start date
2006-01-31
Completion date
2010-07-31
Last updated
2012-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Behavioral/Social, Obesity, Pediatrics, Preventive Medicine

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.

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.

Interventions

BEHAVIORALGroup-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.

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 11 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
BMI Z-score(for Gender and Age)at 6-months6-months post-interventionThe body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.
BMI Z-score(for Gender and Age)at 12-months12-months post-interventionThe body mass index (BMI) for a given age (in years and monthys) and gender (male or female) converted to an exact z-score.

Secondary

MeasureTime frame
Change in Eating Behaviors (Consumption of WHOA Foods), Physical Activity, and Screen Time6- and 12-months post-intervention

Participant flow

Participants by arm

ArmCount
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.
67
Health Education Materials Only
Parent-child dyads 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.
63
Total130

Baseline characteristics

CharacteristicHealth Education Materials OnlyTotalGroup-based Behavioral Intervention
Age, Categorical
<=18 years
63 Participants130 Participants67 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age Continuous9.3 years
STANDARD_DEVIATION 1.4
9.4 years
STANDARD_DEVIATION 1.5
9.5 years
STANDARD_DEVIATION 1.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
63 Participants130 Participants67 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
63 participants130 participants67 participants
Sex: Female, Male
Female
45 Participants94 Participants49 Participants
Sex: Female, Male
Male
18 Participants36 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 670 / 63
serious
Total, serious adverse events
0 / 670 / 63

Outcome results

Primary

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.

Time frame: 12-months post-intervention

ArmMeasureValue (MEAN)Dispersion
Group-based Behavioral InterventionBMI Z-score(for Gender and Age)at 12-months-0.090 Z-scoreStandard Deviation 0.29
Health Education Materials OnlyBMI Z-score(for Gender and Age)at 12-months0.001 Z-scoreStandard Deviation 0.18
Primary

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.

Time frame: 6-months post-intervention

ArmMeasureValue (MEAN)Dispersion
Group-based Behavioral InterventionBMI Z-score(for Gender and Age)at 6-months-0.129 Z-scoreStandard Deviation 0.21
Health Education Materials OnlyBMI Z-score(for Gender and Age)at 6-months0.001 Z-scoreStandard Deviation 0.16
Secondary

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

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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026