PALS-CATCH Intervention for Obesity Prevention Among At-risk Toddlers
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in child Body Mass Index
研究概览
简要总结
The purpose of this study is to learn whether a combination of two research-proven programs, a responsive caregiving parenting program and a childhood obesity prevention program, will have an effect on toddlers' healthy nutrition and physical activity behaviors. Investigators hypothesize that the children participating in the intervention will have significantly lower BMI z-scores, lower intake of sugar sweetened beverages, and increased number of servings of fruits and vegetables, and minutes of physical activity.
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
- 24 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child is 2 - 3 years at the time of enrollment
- •child is >85th percentile for BMI
- •ability of the parents to speak and read in English at the 4th grade level
- •provide primarily in-home care for the children at the time of enrollment
- •child is Medicaid eligible
排除标准
- •acute secondary complications of obesity for child (e.g., severe respiratory insufficiency)
- •child with endocrine abnormalities
- •child with severe obesity (>99.5th BMI percentile)
- •children who have participated in an obesity treatment program within the past year
- •parent with significant sensory impairments (e.g. deaf, blind)
- •parent with BMI >40.0
研究组 & 干预措施
ENRICH
The intervention will integrate the Play and Learning Strategies (PALS) program, a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler with Coordinated Approach To Child Health (CATCH), a behaviorally-based school health promotion program based on Social Cognitive Theory (SCT) to increase opportunities for healthy eating and activity.
干预措施: ENRICH (Behavioral)
Control - monthly handouts
The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children.
干预措施: Control - monthly handouts (Behavioral)
结局指标
主要结局
change in child Body Mass Index
时间窗: baseline and 10 weeks
次要结局
- change in intake of servings of sugar sweetened beverages for the child as assessed using 24 hour parent-reported recalls(baseline and 10 weeks)
- change in total intake of servings fruits and vegetables for the child as assessed using 24 hour parent-reported recalls(baseline and 10 weeks)
- change in daily minutes of physical activity for the child as assessed using accelerometers(baseline and 10 weeks)
研究者
Shreela V Sharma
Associate Professor
The University of Texas Health Science Center, Houston