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

• Authors: Saria Hassan, Emory University; Natasha Sobers, The University of the West Indies; Joanne Paul-Charles, The University of the West Indies; Joseph Herbert, The University of the West Indies; Kavita Dharamraj, South-West Regional Health Authority; Elsie Cruz, University of Puerto Rico School of Medicine; Enid Garcia, University of Puerto Rico School of Medicine; Lyna Fredericks, St. Thomas, U.S. Virgin Islands; Mayur M Desai, Yale University; Shireen Roy, Yale University; Sharon Williams, Virgin Islands University Center for Excellence in Developmental Disabilities; Erika Linnander, Yale University; Cindy Crusto, Yale School of Medicine; Carol R Horowitz, Icahn School of Medicine at Mount Sinai; Guedy Arniella, Institute for Family Health; Adithya Cattamanchi, University of California, San Francisco; Oswald P Adams, The University of the West Indies; Marcella Nunez-Smith, Yale School of Medicine
• Journal Title: Contemporary Clinical Trials Communications
• Volume: Volume 22
• Publisher: (publisher) | 2021-06-01, Pages 100750-100750
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1016/j.conctc.2021.100750
• Subjects: Health Sciences, Public Health; Psychology, General
• Keywords: Adaptation; Caribbean; Diabetes prevention; Hybrid-I; Implementation science; Metformin

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.