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Pediatric ObesityNCT02160847

Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

A study testing DRIVE Program in people with Pediatric Obesity, run by Georgia State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 2 to 65 years
Conditions the study is for
Pediatric Obesity
What is being tested?
DRIVE Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
Sep 2014to Mar 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Georgia State University

    Atlanta, Georgia, 30302

  • Pennington Medical Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
DRIVE Program
Keywords
children, pediatric obesity, parent training, home-based, nutrition, physical activity, parent-child interaction, parenting
Medical subject headings
Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DRIVE ProgramBehavioural

    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

Study groups in NCT02160847
Study groupRoleWhat they receive
DRIVE programExperimentalParticipants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider.
Receives: Behavioral: DRIVE Program
Control GroupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 0, Week 9, Week 19

Secondary outcomes (1)

  1. 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).

    Measured: Week 0, Week 9, Week 19

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02160847
Sponsor's protocol ID
5800752
Status last verified
Dec 2018
First submitted
6 Jun 2014
Last updated
17 Dec 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18055651

  • 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.

  • 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.

    PubMed 11274525

  • 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.

    PubMed 20451244

  • 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.

    PubMed 22681912

  • 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.

    PubMed 15635359

  • 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.

    PubMed 24152742

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing DRIVE Program in people with Pediatric Obesity, run by Georgia State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Child BMIz (time frame: Week 0, Week 9, Week 19). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02160847, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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