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临床试验/NCT02160847
NCT02160847已完成不适用

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

Georgia State University4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
4
主要终点
Change in Child BMIz

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

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.

干预措施: DRIVE Program (Behavioral)

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.

结局指标

主要结局

Change in Child BMIz

时间窗: Week 0, Week 9, Week 19

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).

次要结局

  • Change in Parent BMIz(Week 0, Week 9, Week 19)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jenelle Shanley

Assistant Professor

Georgia State University

研究点 (4)

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