Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284557
Status:
COMPLETED
Last Update Posted:
2012-07-11
First Post:
2006-01-30
Brief Title:
A Primary Care Behavioral Approach for Addressing Childhood Overweight
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Evaluation of a Primary Care-Based Behavioral Intervention for Improving Physical Activity and Nutrition Behaviors Among High-Risk African-American Youth
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 85-94thtogether with a parentcaregiver 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
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 85-94thtogether with a parentcaregiver 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None