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Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

NCT ID: NCT02160847

Last Updated: 2018-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

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.

Conditions

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Pediatric Obesity

Keywords

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children pediatric obesity parent training home-based nutrition physical activity parent-child interaction parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

DRIVE Program

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role collaborator

Georgia State University

OTHER

Sponsor Role lead

Responsible Party

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Jenelle Shanley

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenelle R Shanley, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

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Georgia State University

Atlanta, Georgia, United States

Site Status

Pennington Medical Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18055651 (View on PubMed)

Academy of Nutrition and Dietetics. Public Policy Priority Areas. n.d.; http://www.eatright.org/HealthProfessionals/content.aspx?id=7091#.URxVRGfAGnA.

Reference Type BACKGROUND

Centers for Disease Control and Prevention. Winnable Battles. n.d.; http://www.cdc.gov/WinnableBattles/index.html.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11274525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20451244 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22681912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15635359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24152742 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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5800752

Identifier Type: -

Identifier Source: org_study_id