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Abstract

Background: Rural Appalachian residents experience among the highest prevalence of chronic disease, premature mortality, and decreased life expectancy in the nation. Addressing these growing inequities while avoiding dupli‑ cating existing programming necessitates the development of appropriate adaptations of evidence-based lifestyle interventions. Yet few published articles explicate how to accomplish such contextual and cultural adaptation.

Methods: In this paper, we describe the process of adapting the Make Better Choices 2 (MBC2) mHealth diet and activity randomized trial and the revised protocol for intervention implementation in rural Appalachia. Deploying the NIH’s Cultural Framework on Health and Aaron’s Adaptation framework, the iterative adaptation process included convening focus groups (N=4, 38 participants), conducting key informant interviews (N=16), verifying fndings with our Community Advisory Board (N=9), and deploying usability surveys (N=8), wireframing (N=8), and pilot testing (N=9. This intense process resulted in a comprehensive revision of recruitment, retention, assessment, and interven‑ tion components. For the main trial, 350 participants will be randomized to receive either the multicomponent MBC2 diet and activity intervention or an active control condition (stress and sleep management). The main outcome is a composite score of four behavioral outcomes: two outcomes related to diet (increased fruits and vegetables and decreased saturated fat intake) and two related to activity (increased moderate vigorous physical activity [MVPA] and decreased time spent on sedentary activities). Secondary outcomes include change in biomarkers, including blood pressure, lipids, A1C, waist circumference, and BMI.

Discussion: Adaptation and implementation of evidence-based interventions is necessary to ensure efcacious contextually and culturally appropriate health services and programs, particularly for underserved and vulnerable populations. This article describes the development process of an adapted, community-embedded health interven‑ tion and the fnal protocol created to improve health behavior and, ultimately, advance health equity.

Trial registration: ClinicalTrials.gov Identifer NCT04309461. The trial was registered on 6/3/2020.

Document Type

Article

Publication Date

11-8-2022

Digital Object Identifier (DOI)

https://doi.org/10.1186/s12889-022-14475-0

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