Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare

Study Overview
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Brief Summary
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Investigators will pilot test the impact of an enhanced implementation strategy on implementation and child health outcomes using continuous formative evaluation. Investigators will test the hypothesis that better fidelity to the implementation strategy (WISE) is positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).

Detailed Description
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Investigators will determine whether the enhanced strategy is feasible, acceptable, and demonstrates improved implementation, fidelity, and sustainability using a Hybrid Type 3 implementation design. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis).

Official Title
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Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: WISE (We Inspire Smart Eating)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early childhood educators from our partnering Head Start agency Exclusion Criteria: Secondary Outcome Inclusion Criteria: Children aged 3-5 years old in our partnering Head Start agency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Investigators will use a Type 3 Hybrid Design to test the effectiveness of the enhanced implementation strategy (i.e., facilitation) on uptake while also assessing impacts of the intervention on child outcomes. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis. RE-AIM provides an evaluation framework to assess key aspects of intervention programs implemented in real-word settings. Investigators will modify and use The Organizational Readiness to Change Assessment (ORCA) as developed for use with the i-PARiHS framework to assesses change commitment (e.g., We value this change) and change efficacy (e.g., We can keep the momentum going) both prior to and during implementation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Basic WISE strategy<br>These participants will be asked to implement the basic WISE strategy used in previous studies. | Behavioral: WISE (We Inspire Smart Eating)<br>* An enhanced implementation strategy for evidence-based obesity prevention in childcare<br>|
| Experimental: Enhanced WISE strategy<br>These participants will be asked to implement the enhanced WISE strategy. | Behavioral: WISE (We Inspire Smart Eating)<br>* An enhanced implementation strategy for evidence-based obesity prevention in childcare<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices | The WISE fidelity measure will be used across the school year. The WISE fidelity instrument is rated on a 1 to 4 scale with 4 representing the highest level of fidelity. Each core component is assessed with 2 items. Average fidelity scores above 3 are considered to reflect adequate fidelity on a component. That is, the 2 items on each fidelity component were averaged; an average of above 3 was considered as having achieved fidelity. We are reporting on the total number of classrooms that achieved fidelity in each condition at the spring (final assessment) for the evidence-based practices of WISE. | From Baseline Up to 8 months |