Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

Study Overview
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Brief Summary
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The purpose of this study is to help overweight or obese children to maintain or reduce their body mass index (BMI) through the home-based parent training program the investigators developed called DRIVE. The investigators hypothesize that children from families that receive the DRIVE program will show greater maintenance or improvement in their BMIs than families who do not receive DRIVE.

Detailed Description
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The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program with 15 sessions focused on improve family nutrition and physical activity and promoting positive parent-child interactions. The aim of this study is to pilot-test the development of a childhood obesity program that includes parenting and health information. Participants in this study will be recruited through community organizations based upon their obesity health risk. Only families whose children's BMI percentile is greater than or equal to 75 will be eligible to participate in this study These participants will be randomly assigned to either the control group, in which participants will receive health information via mail only, or the experimental group that will participate in 15 DRIVE sessions focusing on parent-child interactions, health and nutrition, and physical activity. Both groups will complete a baseline assessment, mid-point assessment, and post assessment in their home, which will measure parent and child height, weight, and waist circumference; parent attitudes towards health and nutrition; and parent and child food consumption and physical activity levels. Results from this study will provide information regarding the feasibility of implementing the DRIVE curriculum as well as its impact on parent and child body mass indexes, and parents' knowledge, and attitudes related to nutrition.

Official Title
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Pilot Trial of the DRIVE Parent Training Curriculum to Target Risk Factors for Childhood Obesity

Conditions
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Pediatric Obesity

Intervention / Treatment
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* Behavioral: DRIVE Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child age 2-6 years old with a BMI percentile greater than or equal to 75 Fluent in English Parent has primary custody of the primary child participant in the study Exclusion Criteria: Pregnant or currently breastfeeding (parent) Planning to get pregnant while enrolled in the study (parent) Have BMI greater than 45 (parent) Chronic disease that affects body weight, appetite, or metabolism (for example, diabetes- type I or type II) (child) Have HIV or AIDS (child) Use prescription or over-the-counter medications or herbal products that affect appetite, body weight, or metabolism (child) Plan to move out of the Atlanta/Baton Rouge area for the duration of enrollment (approximately 5 months) (family) Plan to be out of the Atlanta/Baton Rouge area for more than 2 weeks for the duration of enrollment (approximately 5 months) (family)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DRIVE program<br>Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider. | Behavioral: DRIVE Program<br>* The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program, which involves 15 sessions focusing on parent-child interactions, health and nutrition, and physical activity<br>|
| No Intervention: Control Group<br>The parents in the control group will be mailed information on nutrition, physical activity, and parent-child interactions. Information on nutrition will include guidelines provided by the MyPlate website (http://www.choosemyplate.gov/preschoolers.html) in addition to information on proper nutrition and suggest levels of physical activity for preschoolers. Lastly, parents will be provided with the free publication, Adventures in Parenting: How responding, Preventing, Monitoring, Mentoring, and Modeling Can Help You Be A Successful Parent, authored by National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development. Information covered in this document includes effective parenting strategies for children at specific ages. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child BMIz | The child's body mass index z-scores (BMIz) was calculated by dividing the the child's weight in kilograms (measured by a digital scale) by the child's height in meters (measured by a stadiometer). These measurements were taken at each assessment point (pre-, mid-, and post-assessment). | Week 0, Week 9, Week 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parent BMIz | The parent's body mass index z-scores (BMIz) was calculated by dividing the the parent's weight in kilograms (measured by a digital scale) by the parent's height in meters (measured by a stadiometer). These measurements were taken at each assessment point (pre-, mid-, and post-assessment). | Week 0, Week 9, Week 19 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, pediatric obesity, parent training, home-based, nutrition, physical activity, parent-child interaction, parenting