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临床试验/NCT03958214
NCT03958214已完成不适用

Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 244 人开始时间: 2016年11月8日最近更新:
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
244
试验地点
1
主要终点
Change in children's self-control skills: Direct testing

研究概览

简要总结

The purpose of this study is to test the effectiveness of a new curriculum on toddlers' self-regulation skills and healthy eating habits. The curriculum is being delivered as part of Early Head Start home visits and compared to the effectiveness of usual practice Early Head Start home visits.

研究设计

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

盲法说明

All interviews are conducted by research assistants who are blind to study condition.

入排标准

年龄范围
2 Years 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children must be receiving Early Head Start home visits and be at least 2 years old at the beginning of the study.

排除标准

  • 未提供

研究组 & 干预措施

Recipe 4 Success

Experimental

For 12 weeks, home visitors will stop delivering the usual practice Early Head Start home visits and deliver the Recipe 4 Success curriculum instead. At the end of 12 weeks, home visitors will resume usual practice Early Head Start home visits.

干预措施: Recipe 4 Success (Behavioral)

Usual practice Early Head Start

Active Comparator

Home visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs.

干预措施: Usual practice Early Head Start (Behavioral)

结局指标

主要结局

Change in children's self-control skills: Direct testing

时间窗: Baseline / up to 18 months

Children's self-control skills will be assessed through direct testing (e.g., snack delay task)

Change in parents' sensitive/responsiveness: Parent ratings

时间窗: Baseline / up to 18 months

Parents' sensitive/responsiveness will be assessed through parent ratings on standardized surveys; mean scores reported from 5-point Likert scales with higher scores indicating greater sensitive/responsiveness

Change in children's healthy eating habits: Food diaries

时间窗: Baseline / up to 18 months

Healthy eating habits will be assessed through change in consumption of fruits/vegetables and junk food, as assessed with 24-hour food diaries

Change in children's healthy eating habits: Body mass index

时间窗: Baseline / up to 18 months

Healthy eating habits will be assessed through change in body mass index

Change in children's healthy eating habits: Parent reports

时间窗: Baseline / up to 18 months

Healthy eating habits will be assessed through parent survey of pickiness, etc.; mean scores reported from 5-point Likert scales with higher scores indicating healthier eating habits

Change in children's self-control skills: Video interactions

时间窗: Baseline / up to 18 months

Children's self-control skills will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always

Change in children's self-control skills: Parent ratings

时间窗: Baseline / up to 18 months

Children's self-control skills will be assessed through parent ratings on standardized behavior checklists; mean scores reported from 3- or 5-point Likert scales with higher scores indicating greater self-control

Change in parents' sensitive/responsiveness: Video interactions

时间窗: Baseline / up to 18 months

Parents' sensitive/responsiveness will be assessed through parent-child interactions, rated on Likert scale from video recordings; mean score reported between 1 = almost never and 5 = almost always

次要结局

  • Change in children's sleep habits: Parent reports(Baseline / up to 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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