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

NCT05050539 | Active Not Recruiting DMC

• 1 other identifier: 262638
• Study Type: interventional
• Target: 1,850
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Childhood; Nutrition Aspect of Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Early Responders to Low Intensity

ACTIVE COMPARATOR

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).

Behavioral: Low Intensity

Non-Responders Continue Low Intensity

ACTIVE COMPARATOR

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).

Behavioral: Low Intensity

Non-Responders Increasing to High Intensity

EXPERIMENTAL

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).

Behavioral: Low Intensity; Behavioral: High Intensity

Interventions

Low Intensity BEHAVIORAL

5 implementation strategies: formal commitments, local champions, implementation blueprint , remind educators (cutting board with WISE EBPs), task-focused facilitation.

Early Responders to Low Intensity; Non-Responders Continue Low Intensity; Non-Responders Increasing to High Intensity

High Intensity BEHAVIORAL

Low intensity implementation strategies with the addition of holistic individualized facilitation and tailored educational materials.

Non-Responders Increasing to High Intensity

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having classrooms currently using WISE.

Sponsors & Collaborators

• University of Arkansas: lead
• Louisiana Tech University: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Swindle T, Rutledge JM, Selig JP, Painter J, Zhang D, Martin J, Johnson SL, Whiteside-Mansell L, Almirall D, Barnett-McElwee T, Curran GM. Obesity prevention practices in early care and education settings: an adaptive implementation trial. Implement Sci. 2022 Mar 18;17(1):25. doi: 10.1186/s13012-021-01185-1.

  PMID: 35303894 DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Ultrasonic Waves

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Taren M Swindle, Ph.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Trained and field-reliable staff blinded to the study condition will collect data.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An enhanced non-responder trial design will be used to determine the effectiveness (Aim 1) and incremental cost-effectiveness (Aim 3) of an adaptive implementation strategy for WISE, while examining moderators and mediators of the strategy effect (Aim 2). In this trial, sites that do not respond to low-intensity strategies will be randomized to either (a) continue receiving low-intensity strategies or (b) receive high-intensity strategies. This design will determine the effect of an adaptive implementation strategy that adds high intensity versus one that continues with low intensity among non-responder sites.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 20, 2021
• Study Start: June 14, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)