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Author Notes:

Saria Hassan, Email: saria.hassan@emory.edu

SH, MNS, OPA, MD, CH, SW conceptualized the study and contributed to the protocol. AC provided implementation science consultation on the project. EL facilitated the stakeholder engagement meetings. LF, JPC, JH, NS, EG implemented LIME in the island sites. GA served as the T-Trainer expert. SH wrote the first draft of the manuscript. All authors reviewed and edited the manuscript.

We would like to acknowledge all members of the ECHORN Consortium Implementation Work Group. We would also like to acknowledge the hard work of the implementing teams in the USVI, Puerto Rico, Trinidad, and Barbados. We would like to thank all the LIME participants for their time and dedication. We would also like to thank Dr. Kate Lorig and the Self-Management Resource Center for their support. Thanks to the EHPDP Community Advisory Board for sharing this curriculum with us. SH would like to also acknowledge the support of the Yale Scholars for Implementation Science and the UCSF Research in Implementation Science for Health Equity (RISE) Program: R25HL12614 (PI: Bibbins-Domingo).

The authors declare that they have no competing interests.

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Research Funding:

This study was funded by the National Institutes of Health/National Institute on Minority Health and Health Disparities (NIH/NIMHD): U54MD010711 (PI: Nunez-Smith). SH was funded by the National Institutes of Health/National Heart, Lung, and Blood Institute (NIH/NHLBI): K12HL138037 (PI: Bernstein). The funders had no role in the design or conduct of the study. Views expressed are those of the authors and do not represent those of the funding source.

Keywords:

  • Adaptation
  • Caribbean
  • Diabetes prevention
  • Hybrid-I
  • Implementation science
  • Metformin

Diabetes prevention in the Caribbean using Lifestyle Intervention and Metformin Escalation (LIME): Protocol for a hybrid Type-1 effectiveness-implementation trial using a quasi-experimental study design

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Journal Title:

Contemporary Clinical Trials Communications

Volume:

Volume 22

Publisher:

, Pages 100750-100750

Type of Work:

Article | Final Publisher PDF

Abstract:

Background: Globally, several diabetes prevention interventions have been shown to be cost-effective, yet they have had limited adaptation, implementation, and evaluation in the Caribbean and among Caribbean-descent individuals, where the burden of type 2 diabetes is high. We report on the protocol for the Lifestyle Intervention with Metformin Escalation (LIME) study – an evidence-based diabetes prevention intervention to reduce the incidence of diabetes among Caribbean-descent individuals with prediabetes. Methods: LIME is a hybrid type-I effectiveness-implementation quasi-experimental study taking place in 4 clinical sites in Barbados, Trinidad, the U.S. Virgin Islands, and Puerto Rico. LIME targets individuals who self-identify as Caribbean or Caribbean-descent and have high-risk prediabetes with a hemoglobin A1c (HbA1c) between 6 and 6.4%. Eligible participants in the intervention arm are enrolled in a six-week lifestyle modification workshop. Six months later, individuals who have not lost at least 5% of their bodyweight or continue to have an HbA1c of 6% or higher are prescribed metformin medication. In total, participants are followed for one year. The primary effectiveness outcome is proportion of individuals who lower their HbA1c below 6%. Discussion: LIME is a unique diabetes prevention intervention for Caribbean and Caribbean-descent individuals. LIME utilizes a tailored lifestyle change curriculum, incorporates appropriate metformin prescribing when lifestyle change alone is insufficient, targets the highest-risk individuals with prediabetes, and is based in a clinical setting to ensure sustainability.

Copyright information:

© 2021 The Authors

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/rdf).
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