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临床试验/NCT03976089
NCT03976089已完成不适用

Promoting Healthy Development With the Recipe 4 Success Intervention: A Randomized Controlled Trial

University of Wisconsin, Madison0 个研究点目标入组 73 人开始时间: 2013年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
主要终点
Change in children's attention

研究概览

简要总结

10-session home visit intervention conducted within Early Head Start and designed to reduce low-income toddler's obesity risk and improve their self-regulation skills and parents' sensitivity.

详细描述

Recipe 4 Success, the product of a university-community engagement collaboration, uses 10 tightly sequenced, structured, and scripted food preparation lessons, delivered as part of Early Head Start home visits, to help low-income parents learn to sensitively scaffold their toddler's self-regulation skills and establish more healthy eating habits. The intervention relies on an active coaching therapeutic approach to deliver content. Recipe 4 Success is focused on parents because their feeding practices influence children's diet, and interventions to prevent childhood obesity are most likely to have long-term effects when they emphasize positive parenting practices. Parents' sensitivity and constructive scaffolding behaviors are related to children's self-regulation skills, which are robust predictors of healthy eating habits and body mass index (BMI). For example, children who have difficulty with self-regulation by age 3 have a higher BMI through age 12. Importantly, these relations may be causal: Adults who are taught self-regulation skills appear more successful in maintaining healthy eating habits over time. As a preventive intervention, Recipe 4 Success is implemented when children are 2, the point at which deliberate self-regulation skills are starting to emerge and develop rapidly and taste preferences are being formed. Recipe 4 Success is designed for families living in poverty because parents are less likely to provide sensitive scaffolding and children are less likely to display well-developed self-regulation skills and healthy eating habits under conditions of economic adversity. Finally, Recipe 4 Success was created to be integrated into Early Head Start to expedite wide-spread dissemination and easy sustainability and to enhance the efficacy of this nation-wide home visit program. If successful, this will be one of the first preventive interventions to improve either toddler's self-regulation skills or their healthy eating habits and BMI.

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

Families were randomly assigned to condition and either started new Recipe 4 Success home visits for 10 weeks or continued the standard Early Head Start home visits they had been receiving. Interviewers collecting all outcome data were blind to study condition.

入排标准

年龄范围
18 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Family lives in York, Allentown, Williamsport/Lock Haven Pennsylvania
  • Family enrolled in Early Head Start home visit program
  • Target child 18-36 months old at beginning of study

排除标准

  • Family considered "in crisis" by home visitor (i.e., not able to focus on new intervention lessons because of child custody, family violence, mental health, or housing issues that currently demand parents' full attention)

结局指标

主要结局

Change in children's attention

时间窗: Change across three months, from baseline to post-intervention

Children and their parents participated in three interaction tasks. Raters blind to study condition rated the ability of the children to concentrate and stay focused on what they were doing with their parents on a Likert scale with 1=almost never to 5 = almost always.

Change in parents' sensitive scaffolding

时间窗: Change across three months, from baseline to post-intervention

Children and their parents participated in three interaction tasks. Raters blind to study condition rated the ability of the parents to sensitively scaffold their children's learning of a new task on a Likert scale with 1=almost never to 5 = almost always.

Change in willingness to eat healthy food

时间窗: Change across three months, from baseline to post-intervention

As part of the study assessment battery, parents were given novel healthy foods, such as dried seaweed, and asked to see if their children would like to eat them. The percentage of novel foods that children at least tasted was calculated.

Change in children's compliance

时间窗: Change across three months, from baseline to post-intervention

Parents' completed the 8-item compliance subscale of the well-validated Infant and Toddler Social and Emotional Assessment. Each item was rated on a Likert scale with 1 = not true to 3 = very true.

Change in parents' competent parenting

时间窗: Change across three months, from baseline to post-intervention

Children and their parents participated in three interaction tasks. Raters blind to study condition rated the overall competence of the parents on four items such as "The parent seemed very effective in interacting with the child" on a Likert scale with 1=almost never to 5 = almost always.

Change in parents' supportive feeding behaviors

时间窗: Change across three months, from baseline to post-intervention

As part of the study assessment battery, parents were given novel healthy foods, such as dried seaweed, and asked to see if their children would like to eat them. Interviewers blind to study condition rated whether or not parents engaged in four behaviors for each specific snack, such as "Parent modeled enjoyment of health food by tasting it her/himself." The percentage of times parents demonstrated such supportive feeding behaviors was calculated.

Change in percentage of healthy meals consumed

时间窗: Change across three months, from baseline to post-intervention

Daily food diaries were collected across three 24-hour periods. The percentage of meals that included at least one fruit and/or vegetable, at least one source of protein, and that did not include any sweets or junk food was calculated.

Change in children's self-control skills

时间窗: Change across three months, from baseline to post-intervention

Children completed a snack delay task in which an M\&M was placed on a plate but the interviewer asked the children to wait 5-60 seconds before eating the M\&M. The percentage of the four trials in which the child was able to wait the entire time requested before eating the M\&M was calculated.

Change in healthy body weight

时间窗: Change across three months, from baseline to post-intervention

Children's weight and height were collected with standardized scales and tape measures.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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