search
Back to results

Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DRIVE Program
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Obesity focused on measuring children, pediatric obesity, parent training, home-based, nutrition, physical activity, parent-child interaction, parenting

Eligibility Criteria

2 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Georgia State University
  • Pennington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DRIVE program

Control Group

Arm Description

Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
June 6, 2014
Last Updated
December 13, 2018
Sponsor
Georgia State University
Collaborators
Pennington Biomedical Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02160847
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
children, pediatric obesity, parent training, home-based, nutrition, physical activity, parent-child interaction, parenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DRIVE program
Arm Type
Experimental
Arm Description
Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DRIVE Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Child BMIz
Description
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).
Time Frame
Week 0, Week 9, Week 19
Secondary Outcome Measure Information:
Title
Change in Parent BMIz
Description
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).
Time Frame
Week 0, Week 9, Week 19

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenelle R Shanley, PhD
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia State University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30302
Country
United States
Facility Name
Pennington Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18055651
Citation
Barlow SE; Expert Committee. Expert committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics. 2007 Dec;120 Suppl 4:S164-92. doi: 10.1542/peds.2007-2329C.
Results Reference
background
Citation
Academy of Nutrition and Dietetics. Public Policy Priority Areas. n.d.; http://www.eatright.org/HealthProfessionals/content.aspx?id=7091#.URxVRGfAGnA.
Results Reference
background
Citation
Centers for Disease Control and Prevention. Winnable Battles. n.d.; http://www.cdc.gov/WinnableBattles/index.html.
Results Reference
background
PubMed Identifier
11274525
Citation
Dietz WH, Gortmaker SL. Preventing obesity in children and adolescents. Annu Rev Public Health. 2001;22:337-53. doi: 10.1146/annurev.publhealth.22.1.337.
Results Reference
background
PubMed Identifier
20451244
Citation
Han JC, Lawlor DA, Kimm SY. Childhood obesity. Lancet. 2010 May 15;375(9727):1737-48. doi: 10.1016/S0140-6736(10)60171-7. Epub 2010 May 5.
Results Reference
background
PubMed Identifier
22681912
Citation
Haynos AF, O'Donohue WT. Universal childhood and adolescent obesity prevention programs: review and critical analysis. Clin Psychol Rev. 2012 Jul;32(5):383-99. doi: 10.1016/j.cpr.2011.09.006. Epub 2011 Sep 22.
Results Reference
background
PubMed Identifier
15635359
Citation
Koplan JP, Liverman CT, Kraak VI; Committee on Prevention of Obesity in Children and Youth. Preventing childhood obesity: health in the balance: executive summary. J Am Diet Assoc. 2005 Jan;105(1):131-8. doi: 10.1016/j.jada.2004.11.023. No abstract available.
Results Reference
background
PubMed Identifier
24152742
Citation
Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity among adults: United States, 2011-2012. NCHS Data Brief. 2013 Oct;(131):1-8.
Results Reference
background
Citation
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.
Results Reference
background

Learn more about this trial

Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

We'll reach out to this number within 24 hrs