Clinical Trial

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

Completed
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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.
Protocol Amendment History 4 changes
critical Trial completed 2026-08-12
notable Enrollment reduced: 1850 -> 1613 participants 2026-08-12
notable Primary completion moved earlier: 2026-06-30 -> 2025-05-30 2026-08-12
minor Completion moved earlier: 2026-12-30 -> 2026-05-29 2026-08-12
Trial Details
NCT Number NCT05050539
Lead Sponsor University of Arkansas
Collaborators: Louisiana Tech University
Conditions Obesity, Childhood, Nutrition Aspect of Cancer
Enrollment 1,613 participants
Start Date 2022-06-14
Primary Completion 2025-05-30 (estimated)
Study Completion 2026-05-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-11