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

Taren Swindle, Susan L Johnson, Leanne Whiteside-Mansell, Geoffrey M Curran, Taren Swindle, Susan L Johnson, Leanne Whiteside-Mansell, Geoffrey M Curran

Abstract

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.

Keywords: Childcare; Implementation science; Implementation strategies; Obesity prevention.

Conflict of interest statement

Ethics approval and consent to participate

This protocol was approved by the UAMS Institutional Review Board (IRB 205335). This study will be conducted in accordance with all applicable government regulations and University of Arkansas for Medical Sciences research policies and procedures. Consent was waived by the IRB for EBQI stakeholders but will be collected for teachers and parents participating in the Hybrid III Trial using IRB-approved forms.

Waivers of informed consent and Health Insurance Portability and Accountability Act of 1996 authorization were approved for this project as this research involves no more than minimal risk to the subjects; waivers will not adversely affect the rights and welfare of the subjects; and the research could not practicably be carried out with the waiver.

Consent for publication

Not applicable.

Competing interests

Dr. Leanne Whiteside-Mansell, Dr. Taren Swindle, and UAMS have a financial interest in the technology (WISE) discussed in this presentation/publication. These financial interests have been reviewed and approved in accordance with the UAMS conflict of interest policies. The other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Research aims and design

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