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Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Pediatric Obesity
Intervention Behavioral: DRIVE Program
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DRIVE Program Control Group
Hide Arm/Group Description

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

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

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.
Period Title: Overall Study
Started 16 16
Completed 16 16
Not Completed 0 0
Arm/Group Title DRIVE Program Control Group Total
Hide Arm/Group Description

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

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

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. Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Child Number Analyzed 8 participants 8 participants 16 participants
3.88  (1.81) 4.25  (1.67) 4.06  (1.69)
Parent Number Analyzed 8 participants 8 participants 16 participants
35.75  (5.04) 34.5  (5.86) 35.13  (5.32)
[1]
Measure Analysis Population Description: Child and parent population descriptions were separated for the demographic data.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Child Number Analyzed 8 participants 8 participants 16 participants
Female
3
  37.5%
5
  62.5%
8
  50.0%
Male
5
  62.5%
3
  37.5%
8
  50.0%
Parent Number Analyzed 8 participants 8 participants 16 participants
Female
8
 100.0%
7
  87.5%
15
  93.8%
Male
0
   0.0%
1
  12.5%
1
   6.3%
[1]
Measure Analysis Population Description: Child and parent population descriptions were separated for the demographic data.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Child Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
1
  12.5%
0
   0.0%
1
   6.3%
Not Hispanic or Latino
7
  87.5%
8
 100.0%
15
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Parent Number Analyzed 8 participants 8 participants 16 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
8
 100.0%
16
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Child Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  25.0%
5
  62.5%
7
  43.8%
White
5
  62.5%
3
  37.5%
8
  50.0%
More than one race
1
  12.5%
0
   0.0%
1
   6.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Parent Number Analyzed 8 participants 8 participants 16 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  25.0%
5
  62.5%
7
  43.8%
White
6
  75.0%
3
  37.5%
9
  56.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: Child and parent population descriptions were separated for the demographic data.
1.Primary Outcome
Title Change in Child BMIz
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DRIVE Program Control Group
Hide Arm/Group Description:

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

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

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.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: BMIz
Change from Week 0 to Week 9 -0.21  (0.53) 0.26  (0.44)
Change from Week 0 to Week 19 -.05  (0.32) 0.41  (.058)
2.Secondary Outcome
Title Change in Parent BMIz
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DRIVE Program Control Group
Hide Arm/Group Description:

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

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

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.
Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: BMIz
Change from Week 0 to Week 9 -0.53  (0.83) -0.69  (2.19)
Change from Week 0 to Week 19 -1.16  (1.44) -0.59  (3.54)
Time Frame At each assessment point, Week 0, Week 9, and Week 19.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DRIVE Program Control Group
Hide Arm/Group Description

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

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

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.
All-Cause Mortality
DRIVE Program Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
DRIVE Program Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DRIVE Program Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jenelle Shanley Chatham
Organization: Georgia State University
Phone: 404-413-1340
EMail: jshanley@gsu.edu
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.
Layout table for additonal information
Responsible Party: Jenelle Shanley, Georgia State University
ClinicalTrials.gov Identifier: NCT02160847    
Other Study ID Numbers: 5800752
First Submitted: June 6, 2014
First Posted: June 11, 2014
Results First Submitted: May 19, 2017
Results First Posted: October 26, 2018
Last Update Posted: December 17, 2018