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Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

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ClinicalTrials.gov Identifier: NCT02160847
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : October 26, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Jenelle Shanley, Georgia State University

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Behavioral: DRIVE Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Trial of the DRIVE Parent Training Curriculum to Target Risk Factors for Childhood Obesity
Study Start Date : September 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: DRIVE program
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
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

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Change in Child BMIz [ Time Frame: Week 0, Week 9, Week 19 ]
    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).


Secondary Outcome Measures :
  1. Change in Parent BMIz [ Time Frame: Week 0, Week 9, Week 19 ]
    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).



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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160847


Locations
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United States, Georgia
Georgia State University
Atlanta, Georgia, United States, 30302
United States, Louisiana
Pennington Medical Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Georgia State University
Pennington Biomedical Research Center
Investigators
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Principal Investigator: Jenelle R Shanley, PhD Georgia State University
Publications:
Academy of Nutrition and Dietetics. Public Policy Priority Areas. n.d.; http://www.eatright.org/HealthProfessionals/content.aspx?id=7091#.URxVRGfAGnA.
Centers for Disease Control and Prevention. Winnable Battles. n.d.; http://www.cdc.gov/WinnableBattles/index.html.
US Department of Health and Human Services. Strategic Plan for NIH Obesity Research: A Report of the NIH Obesity Research Task Force. 2011. http://obesityresearch.nih.gov/about/StrategicPlanforNIH_Obesity_Research_Full-Report_2011.pdf.

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Responsible Party: Jenelle Shanley, Assistant Professor, Georgia State University
ClinicalTrials.gov Identifier: NCT02160847    
Other Study ID Numbers: 5800752
First Posted: June 11, 2014    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jenelle Shanley, Georgia State University:
children
pediatric obesity
parent training
home-based
nutrition
physical activity
parent-child interaction
parenting
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight