SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study: Protocol for diabetes medical nutrition therapy randomized clinical trial among African American women

Abstract

BackgroundAfrican American (AA) women with type 2 diabetes (T2D) carry disproportionate diabetes-related morbidity and mortality burdens. Diabetes medical nutrition therapy (MNT) improves glycemic, blood pressure, and cholesterol control, all critical in preventing and reducing diabetes complications. Yet, MNT does not address low motivation for dietary intake management, which is frequently reported among AA women with T2D living in the Southeastern US. MethodsA randomized controlled trial will be used to test the central hypothesis that diabetes MNT plus culturally-tailored motivational interviewing (MI) (diabetes MNT plus MI) is more effective than diabetes MNT alone (diabetes MNT). Two hundred ninety-one Southeastern AA women who are at risk for development and/or progression of T2D complications will be randomized to diabetes MNT plus MI or diabetes MNT. Both groups will include: 1) a 3-month active intervention period, consisting of group-based, nutritionist-facilitated MNT sessions; 2) a 3-month maintenance intervention period, including one group-based, nutritionist-facilitated maintenance support session; and 3) a 6-month inactive period. Culturally-adapted MI exercises will be integrated into the diabetes MNT plus MI group only. Primary (HbA1c) and secondary (systolic blood pressure, LDL cholesterol) outcomes will be assessed at baseline and 3, 6, and 12 months following the active intervention period. DiscussionThe results from this study, called the SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study, are vital to the adoption and uptake of rigorously-tested MNT interventions that address motivation among AA women with T2D as a way to reduce their risk and/or progression of diabetes-related complications.