Adaptive Implementation to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings

Obesity, Childhood Clinical Trial

Official title:

Testing an Adaptive Implementation Strategy to Optimize Delivery of Obesity Prevention Practices in Early Care and Education Settings

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050539
• Other study ID #: 262638
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: University of Arkansas
• Contact: Taren M Swindle, Ph.D.
• Phone: 501-526-7058
• Email: tswindle[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

"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.

Description:

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.

Specific Aim 2. Examine moderators and mediators of implementation outcomes in a mixed-methods design. For moderation, the hypothesis is that sites with weaker organizational readiness and less experienced educators will require high intensity strategies to reach fidelity. For mediation, the expectation is that educators' perceptions of barriers, implementation climate, and implementation leadership will mediate the effect of the strategies on implementation outcomes. Using an explanatory, sequential design, qualitative data at purposively selected sites (N =20) will be collected to identify emergent moderators and mediators.

Specific Aim 3. Assess the incremental cost-effectiveness of the adaptive implementation strategy. In this aim, cost per unit of fidelity associated with the adaptive implementation strategy will be estimated based on a meaningful difference in the research team's previously published fidelity measure. Results will also determine the incremental cost-effectiveness of applying the adaptive strategy compared to continuing low-intensity strategies for improving child health outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1850
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Having classrooms currently using WISE.

Related Conditions & MeSH terms

• Nutrition Aspect of Cancer
• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Low Intensity
5 implementation strategies: formal commitments, local champions, implementation blueprint , remind educators (cutting board with WISE EBPs), task-focused facilitation.
• High Intensity
Low intensity implementation strategies with the addition of holistic individualized facilitation and tailored educational materials.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Louisiana Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure	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.	Through study completion, an average of 2 years