Testing an Adaptive Implementation Strategy to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,613
- 试验地点
- 1
- 主要终点
- Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure
研究概览
简要总结
"Together, We Inspire Smart Eating" (WISE) is an intervention that improves children's diets in ECE. WISE includes 4 key evidence-based practices (EBPs): (1) hands-on exposures to fruits and vegetables, (2) role modeling by educators, (3) positive feeding practices, and (4) a mascot associated with fruits and vegetables. Standard implementation approaches to WISE result in suboptimal implementation of WISE EBPs. Additional implementation strategies are needed to increase adoption and fidelity to EBPs.
To date, most studies have employed an "all-or-nothing" approach, comparing multifaceted strategies to control groups without implementation support. Thus, there is an urgent need for optimized strategies that tailor implementation support intensity to the unique challenges and limited resources of the ECE context. The overall objectives of this application are to determine the effectiveness and cost-effectiveness of an adaptive implementation approach to improve adoption of the EBPs of WISE while also examining implementation mechanisms. The central hypothesis is that the addition of high-intensity strategies at sites that do not respond to low-intensity strategies will improve implementation and health outcomes.
详细描述
In the US, 4 out of 10 children are overweight or obese by age, and few children between 2 and 5 years old meet dietary guidelines. Consuming a healthy diet (e.g., fiber, antioxidant-rich foods) and maintaining a healthy weight protect against cancer and cancer-related mortality. Arkansas and Louisiana are among the states with the highest obesity rates, lowest quality diets, and highest cancer rates in the US. Given that early life patterns track into adulthood, early interventions are needed to decrease cancer risk later in life. Importantly, studies in early care and education (ECE, i.e., childcare) found that 80% of dietary programs and 70% of programs focusing on health behaviors demonstrated positive effects. Thus, ECE is a promising cancer prevention setting. However, intervention implementation in ECE is a challenge.
""Together, We Inspire Smart Eating" (WISE) is an intervention that improves children's diets in ECE. WISE includes 4 key evidence-based practices (EBPs): (1) hands-on exposures to fruits and vegetables, (2) role modeling by educators, (3) positive feeding practices to support children's self-regulation, and (4) a mascot associated with fruits and vegetables. Prior work by the study team documented that standard implementation approaches to WISE (i.e., training and reminders only) result in suboptimal implementation of WISE EBPs. Additional implementation strategies are needed to increase adoption and fidelity to EBPs.
To date, few studies have compared implementation strategies to improve EBP uptake in ECE. Available studies have had a strong emphasis on policy, with results supporting the positive effect of multifaceted strategies. However, these studies often used an "all-or-nothing" approach, comparing costly multifaceted strategies to control groups with no implementation support. Knowledge is limited on the intensity of implementation strategies that are needed to yield success; some organizations may need more intense strategies than others. Thus, there is a critical need for optimized implementation strategies that tailor intensity (high vs. low) to the unique challenges and limited resources of ECE. Further, understanding how strategies work and for whom (i.e., implementation mechanisms) will advance implementation efforts in ECE.
The research team's foundational work (K01-DK110141) showed that a high-intensity implementation strategy package outperformed a standard implementation for WISE. However, it is likely not possible or necessary to provide a high-intensity strategy to all sites in wider dissemination. The proposed project will determine the optimal implementation intensity needed to improve the uptake of WISE EBPs in ECE. The overall objectives of this project are to determine the effectiveness and cost-effectiveness of an adaptive implementation approach to improve adoption of the WISE EBPs while also examining moderators and mediators of response to the strategies. The central hypothesis is that the addition of high-intensity strategies at sites that do not respond to low-intensity strategies will improve implementation and health outcomes compared to the continuation of low-intensity strategies. The research team's long-term goal is to increase EBP implementation in the ECE setting to improve health outcomes for children. Thus, the following specific aims are proposed:
Specific Aim 1. Determine the effectiveness of an adaptive implementation strategy that tailors the intensity of implementation support versus a low-intensity strategy. Using an enhanced non-responder trial, we will compare the effect of continuing low-intensity strategies vs. augmenting with high-intensity strategies to implement WISE. Low-intensity includes task-focused facilitation aimed at leaders; high intensity includes holistic, individualized facilitation aimed at educators. Non-responder sites (N =64) will be randomized to continue with the low-intensity strategies or to add high-intensity strategies. The hypothesis is that, on average, sites receiving high-intensity strategies will outperform sites continuing the low-intensity strategies on the primary outcome of intervention fidelity and on secondary implementation and child health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Trained and field-reliable staff blinded to the study condition will collect data.
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
- 否
入选标准
- •Recruited teachers at participating early care and education site in the following 4 geographic regions: (1) Central Arkansas, (2) Arkansas River Valley, (3) North, Central Louisiana, and (4) Southeast Louisiana.
- •Participation in Child and Adult Care Food Program in the states' quality rating system
- •Serving at least 15 children age 3 to 5
- •Agreeing to participate in implementation activities and data collection in all 3- to 5-year-old classrooms
- •Having no classrooms currently using WISE.
排除标准
- •Having classrooms currently using WISE.
研究组 & 干预措施
Early Responders to Low Intensity
Early responders will include those with targeted levels of fidelity by the October assessment. They will continue to receive low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).
干预措施: Low Intensity (Behavioral)
Non-Responders Increasing to High Intensity
This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to have high intensity support added (low intensity + holistic individualized facilitation, tailored educational materials).
干预措施: Low Intensity (Behavioral)
Non-Responders Increasing to High Intensity
This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to have high intensity support added (low intensity + holistic individualized facilitation, tailored educational materials).
干预措施: High Intensity (Behavioral)
Non-Responders Continue Low Intensity
This group will include those not achieving desired levels of fidelity by the October assessment who will be randomized to continue receiving low intensity implementation support (i.e., formal commitments, local champions, implementation blueprint, reminder cutting boards, task-focused implementation).
干预措施: Low Intensity (Behavioral)
结局指标
主要结局
Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure
时间窗: Through study completion, an average of 2 years
Fidelity to the WISE Evidence-Based Practices at the classroom level measured with the the WISE fidelity observational measure. The measure includes 2 to 3 items per evidence-based practice (EBP) on a 1 (minimum) to 4 (maximum) scale to receive an average, continuous fidelity score with 4 representing the highest fidelity (i.e., higher scores reflect better fidelity). For each item, values are anchored to concrete, observable behaviors.
次要结局
未报告次要终点
