Clinical trial NCT02160847: Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors
Official title: Pilot Trial of the DRIVE Parent Training Curriculum to Target Risk Factors for Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: children
pediatric obesity
parent training
home-based
nutrition
physical activity
parent-child interaction
parenting
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
First posted: 2014-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Child BMIz
timeFrame: Week 0, Week 9, Week 19
Secondary outcomes:
measure: Change in Parent BMIz
timeFrame: Week 0, Week 9, Week 19
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
city: Baton Rouge
country: United States
facility: Pennington Medical Center
state: Louisiana
Study officials:
affiliation: Georgia State University
name: Jenelle R Shanley, PhD
role: PRINCIPAL_INVESTIGATOR
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