A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial
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Updated: Feb 26, 2026

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Published on: February 2, 2017
Taren Swindle1, Susan L Johnson2, Leanne Whiteside-Mansell3
1Department of Family and Preventive Medicine, University of Arkansas for Medical Sciences, 4301 W. Markham St, #530, Little Rock, AR, 72205-7199, USA. tswindle@uams.edu.
Insights
This study tested strategies to implement obesity prevention practices in childcare settings. An enhanced strategy improved uptake and fidelity of evidence-based practices among educators and children.
Area of Science:
- Childhood obesity prevention research
- Implementation science in public health
- Early childhood education and nutrition
Background:
- A gap exists between evidence-based obesity prevention practices and their implementation in childcare settings.
- Few studies investigate how implementation strategies impact the adoption of these practices.
- Childcare settings offer a crucial opportunity to reach at-risk children.
Purpose of the Study:
- To develop and test implementation strategies for evidence-based obesity prevention practices in childcare.
- To compare a basic implementation strategy with an enhanced, stakeholder-informed strategy.
- To evaluate the impact of these strategies on practice uptake, fidelity, and maintenance.
Main Methods:
- A three-phase approach using a stakeholder-driven, evidence-based quality improvement process.
- A Hybrid Type III cluster randomized trial comparing basic versus enhanced implementation strategies.
- Utilizing the RE-AIM model to assess outcomes like Reach, Effectiveness, Adoption, Implementation, and Maintenance.
Main Results:
- The study protocol outlines the systematic development and testing of tailored implementation strategies.
- The enhanced strategy aims to improve the uptake, fidelity, and maintenance of obesity prevention practices.
- Outcomes will be evaluated using the RE-AIM framework.
Conclusions:
- A stakeholder-driven approach can enhance the implementation, fidelity, and maintenance of evidence-based obesity prevention practices in childcare.
- This study provides a model for developing and testing tailored implementation strategies in early childhood settings.
Background:
Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention).
Methods:
Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial.
Discussion:
This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop and test a tailored, enhanced implementation strategy.
Trial Registration:
ClinicalTrials.gov, NCT03075085.
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