Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02160847
• Other study ID #: 5800752
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: December 2018
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia
United States	Pennington Medical Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Georgia State University	Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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. — View Citation

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

Dietz WH, Gortmaker SL. Preventing obesity in children and adolescents. Annu Rev Public Health. 2001;22:337-53. Review. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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