Trial Outcomes & Findings for Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors (NCT NCT02160847)

Last Updated: 2018-12-17

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Week 0, Week 9, Week 19

Results posted on

2018-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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	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.
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Child and parent population descriptions were separated for the demographic data.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Week 0, Week 9, Week 19

Outcome measures

Outcome measures
Measure	DRIVE Program n=8 Participants 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	Control Group n=8 Participants 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.
Change in Child BMIz Change from Week 0 to Week 9	-0.21 BMIz Standard Deviation 0.53	0.26 BMIz Standard Deviation 0.44
Change in Child BMIz Change from Week 0 to Week 19	-.05 BMIz Standard Deviation 0.32	0.41 BMIz Standard Deviation .058

SECONDARY outcome

Timeframe: Week 0, Week 9, Week 19

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).

Outcome measures

Outcome measures
Measure	DRIVE Program n=8 Participants 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	Control Group n=8 Participants 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.
Change in Parent BMIz Change from Week 0 to Week 9	-0.53 BMIz Standard Deviation 0.83	-0.69 BMIz Standard Deviation 2.19
Change in Parent BMIz Change from Week 0 to Week 19	-1.16 BMIz Standard Deviation 1.44	-0.59 BMIz Standard Deviation 3.54

Adverse Events

DRIVE Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jenelle Shanley Chatham

Georgia State University

Phone: 404-413-1340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	DRIVE Program n=16 Participants 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	Control Group n=16 Participants 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 n=32 Participants Total of all reporting groups
Age, Continuous Child	3.88 years STANDARD_DEVIATION 1.81 • n=8 Participants • Child and parent population descriptions were separated for the demographic data.	4.25 years STANDARD_DEVIATION 1.67 • n=8 Participants • Child and parent population descriptions were separated for the demographic data.	4.06 years STANDARD_DEVIATION 1.69 • n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Age, Continuous Parent	35.75 years STANDARD_DEVIATION 5.04 • n=8 Participants • Child and parent population descriptions were separated for the demographic data.	34.5 years STANDARD_DEVIATION 5.86 • n=8 Participants • Child and parent population descriptions were separated for the demographic data.	35.13 years STANDARD_DEVIATION 5.32 • n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Sex: Female, Male Child · Female	3 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	5 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	8 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Sex: Female, Male Child · Male	5 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	3 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	8 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Sex: Female, Male Parent · Female	8 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	7 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	15 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Sex: Female, Male Parent · Male	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	1 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	1 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Ethnicity (NIH/OMB) Child · Hispanic or Latino	1 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	1 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Ethnicity (NIH/OMB) Child · Not Hispanic or Latino	7 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	8 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	15 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Ethnicity (NIH/OMB) Child · Unknown or Not Reported	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Ethnicity (NIH/OMB) Parent · Hispanic or Latino	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Ethnicity (NIH/OMB) Parent · Not Hispanic or Latino	8 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	8 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	16 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Ethnicity (NIH/OMB) Parent · Unknown or Not Reported	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Child · American Indian or Alaska Native	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Child · Asian	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Child · Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Child · Black or African American	2 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	5 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	7 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Child · White	5 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	3 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	8 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Child · More than one race	1 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	1 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Child · Unknown or Not Reported	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Parent · American Indian or Alaska Native	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Parent · Asian	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Parent · Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Parent · Black or African American	2 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	5 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	7 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Parent · White	6 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	3 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	9 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Parent · More than one race	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.
Race (NIH/OMB) Parent · Unknown or Not Reported	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=8 Participants • Child and parent population descriptions were separated for the demographic data.	0 Participants n=16 Participants • Child and parent population descriptions were separated for the demographic data.