Adaptation and study protocol of the evidence-based Make Better Choices (MBC2) multiple diet and activity change intervention for a rural Appalachian population

Nancy E. Schoenberg, Deanna Sherman, Angela Fidler Pfammatter, Michelle K. Roberts, Ming Yuan Chih, Sarah C. Vos, Bonnie Spring

Research output: Contribution to journalArticlepeer-review

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 duplicating 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 findings 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 intervention 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 efficacious 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 intervention and the final protocol created to improve health behavior and, ultimately, advance health equity. Trial registration: ClinicalTrials.gov Identifier NCT04309461. The trial was registered on 6/3/2020.

Original languageEnglish
Article number2043
JournalBMC Public Health
Volume22
Issue number1
DOIs
StatePublished - Dec 2022

Bibliographical note

Funding Information:
Funding Support for this research was provided through the National Institutes of Health/ National Heart, Lung, and Blood Institute through R01HL152714, “Implementing an evidence-based mHealth diet and activity intervention: Make Better Choices 2 for rural Appalachians”, MPIs Schoenberg & Spring. The funder provided peer reviewed comments which the investigators used to refine the protocol. However, The funding body played no role in study design, data collection, analysis, interpretation of data, or manuscript preparation.

Funding Information:
The authors would like to thank Sherry Tinsley, the MBC2 Community Advisory Board, and numerous local community members who generously provided their insights.

Funding Information:
This study takes place in Appalachian Kentucky, an area that includes 54 counties in the eastern part of the state. Data collection sites include community locations in Harlan County and Fayette County, Kentucky, USA. To ensure the fit of the evidence-based MBC2 intervention [] for a rural population and setting, we employed an iterative cultural adaptation approach, engaging in several steps to assess the MBC2 intervention’s acceptability, feasibility, and need for cultural and contextual adaptation. Our overall model of adaptation was based on the NIH’s Cultural Framework of Health [] and Aaron’s Adaptation framework []. With support from a $50,000 pilot grant through the University of Kentucky’s Center of Research in Obesity and Cardiovascular Disease, we conducted a series of focus groups (FG, N = 38) and key informant interviews (KII, N = 16). We verified our findings from the FG and KII and field-tested instruments with our Community Advisory Board (CAB, N = 9). We then engaged in wireframe testing (N = 8), followed by a usability survey (N = 8) with new participants. Revising the protocol and contents with each new activity, we then pilot tested the adapted MBC2 program with eligible participants (N = 9). We analyzed the results through template coding and descriptive statistics.

Publisher Copyright:
© 2022, The Author(s).

Keywords

  • Community-based participatory research
  • Diet
  • Exercise
  • Mobile phone
  • Rural populations
  • Technology

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

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