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临床试验/NCT07107321
NCT07107321Enrolling By Invitation不适用

Deimplementation of Inappropriate Feeding Practices in Early Care and Education Settings

Arkansas Children's Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 2,640 人开始时间: 2025年8月12日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
2,640
试验地点
2
主要终点
Table Talk

研究概览

简要总结

Arkansas and Louisiana have among the highest rates of adult obesity in the United States at 38.7% and 38.6%, respectively. Prevention and intervention efforts are needed to reduce the number of children who will become obese adults and suffer the host of negative health consequences that accompany it. This proposal will develop and test strategies to stop the use of detrimental feeding practices by early childhood educators which promote unhealthy weight trajectories, inappropriate eating behaviors and poor dietary outcomes for children.

详细描述

The long-term goal is to accelerate the implementation of evidence-based feeding practices in ECE settings that support healthy weight trajectories and diets for young children. The overall objective for this application, which is in response to PAR-22-105, is to determine the effectiveness and associated mechanisms of a package of deimplementation strategies to reduce the use of inappropriate feeding practices in ECE. The co-designed package of de-implementation strategies in this project will test includes six complimentary strategies. Three are foundational strategies that all educators will receive: training, a peer learning collaborative, and facilitation; three strategies are tailored to each educator's preferences for support and individual goals: audit and feedback, reminders, and educational resources. These six strategies will simultaneously support the removal of inappropriate practices and the uptake of alternative EBPs. To accomplish this goal, the strategies will target trust as a key mechanism for change, consistent with the Implementation Trust Building Theory of Change.

The rationale for the proposed project is that demonstrating the effectiveness of strategies for reducing inappropriate feeding practices in ECE and determining how the strategies work and for whom will provide new opportunities for their continued development and dissemination. In turn, these strategies will contribute to a strong foundation for lifelong healthy eating habits for children being served in ECE. This project includes a cluster-randomized Hybrid Type III trial with 88 ECE sites serving children ages 3 and 5. The trial will achieve two specific aims:

Aim 1: Determine the effectiveness of a package of deimplementation strategies for reducing the use of inappropriate feeding practices in ECE. The hypothesis is that, compared to usual practice, the deimplementation strategies will be effective at reducing the total number of observed inappropriate feeding practices per meal, our primary deimplementation outcome (N= 88 sites, 528 educators). This project will also identify effects on secondary effectiveness outcome measures including child body mass index, willingness to try new foods, fear of new foods (i.e., neophobia), and dietary intake (N=1320 children).

Aim 2: Identify mechanisms of deimplementation using a mixed methods approach. The hypothesis is that factors specified by the Implementation Trust Building Theory of Change22 will mediate the effect of strategies on deimplementation outcomes. Using an explanatory, sequential design, we will collect qualitative data with purposively selected educators (N = 32) to identify emergent mediators and moderators.

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)

入排标准

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

入选标准

  • Sites within a 100-mile radius of staff offices serving 12+ children ages 3 to 5 years
  • Agreeing to participate in data collection
  • Sites will serve meals.
  • All classrooms at a site will receive the same deimplementation strategies and participate in data collection. We will select one classroom at random per site to participate in the collection of child outcomes (N= 264 classrooms, 15 children per classroom= 1320 children total).

排除标准

  • We will exclude sites that have participated in intervention studies with our team in the last 3 years.

结局指标

主要结局

Table Talk

时间窗: Five times: (1) baseline in the spring of the year prior to training, (2,3) during winter and spring in the implementation school year, and (4,5) during the fall of the following two school years.

This observational instrument includes the ability to rate the use of eight inappropriate and six evidence-based feeding practices within a single mealtime (approximately 30 minutes). Trained and field-reliable staff blinded to the study condition will collect fidelity data consistent with published protocols. This tool is not affected by ceiling effects are other measures feeding practices. That is, each discrete use of the 14 target feeding practices is captured. Continuous composite scores for inappropriate and evidence-based feeding practices will be used.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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