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| Name | Class |
|---|---|
| Pennington Biomedical Research Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DRIVE program | Experimental | Participants in the experimental group will receive the DRIVE curriculum (15 sessions) via weekly sessions conducted in their home by a DRIVE provider. |
|
| Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DRIVE Program | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jenelle R Shanley, PhD | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30302 | United States | ||
| Pennington Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18055651 | Background | 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. | |
| Background | Academy of Nutrition and Dietetics. Public Policy Priority Areas. n.d.; http://www.eatright.org/HealthProfessionals/content.aspx?id=7091#.URxVRGfAGnA. | ||
| Background | Centers for Disease Control and Prevention. Winnable Battles. n.d.; http://www.cdc.gov/WinnableBattles/index.html. | ||
| 11274525 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child and parent population descriptions were separated for the demographic data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | BMIz | Week 0, Week 9, Week 19 |
|
At each assessment point, Week 0, Week 9, and Week 19.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jenelle Shanley Chatham | Georgia State University | 404-413-1340 | jshanley@gsu.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Baton Rouge |
| Louisiana |
| 70808 |
| United States |
| 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. |
| 20451244 | Background | 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. |
| 22681912 | Background | 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. |
| 15635359 | Background | 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. |
| 24152742 | Background | 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. |
| Background | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Child and parent population descriptions were separated for the demographic data. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Child and parent population descriptions were separated for the demographic data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Child and parent population descriptions were separated for the demographic data. | Count of Participants | Participants |
|
| 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. |
|
|
| 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). | Posted | Mean | Standard Deviation | BMIz | Week 0, Week 9, Week 19 |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| Male |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|