The REAL HEALTH Diabetes study was a pragmatic trial of an intensive lifestyle intervention (ILI) for patients with type 2 diabetes (T2DM) adapted from Look AHEAD for delivery in routine primary care settings in English and Spanish. Given the high prevalence of T2DM in the Latino population, underrepresentation of this population in research, and disparities in outcomes, we evaluated the experience of Spanish speakers, as compared to English speakers, screened for and enrolled in REAL HEALTH. The trial screened 715 patients who spoke Spanish as a primary language, of whom 17 subjects (8.1% of enrollees, 2.4% of screened Spanish speakers) enrolled in the study. Compared to English speakers, Spanish speakers were less likely to decline participation due to lack of interest (OR 0.43, p<0.01) and equally likely to attend a screening visit (p=0.54) but more likely to be lost to recruitment due to inability to contact the patient for a phone screen (OR 2.0, p<0.01). Engagement of Spanish speakers was lower than among English speakers, with lower rates of completion of the ILI (OR 0.22, p=0.04) and a trend for lower attendance for medical nutrition therapy. Despite this, Spanish-speakers had higher increases in (p=0.01) and final levels of (p=0.03) self-reported physical activity. Weight loss at 12 months in the ILI did not significantly differ between groups (2.8kg among Spanish-speakers vs. 4.8kg among English speakers, p=0.11). It is important to recognize barriers to clinical trial and ILI engagement, as well as the nuances of experiences and outcomes within clinical trials. Enrollment of Spanish speakers was limited by difficulty contacting potential subjects, despite extensive recruitment efforts by study staff. Enrolled participants engaged differently but had similar weight loss compared to English speakers in the ILI. Spanish-speakers represent a unique group who may benefit from tailored interventions.
S. Cromer: Employee; Spouse/Partner; Johnson & Johnson. A.R. Rodriguez: None. L. Bissett: None. A. Dushkin: None. V.M. Goldman: None. J. McCarthy: None. L.M. Delahanty: Advisory Panel; Self; Jana Care Inc., Omada Health, Weight Watchers International, Inc. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S.
National Institutes of Health (T32DK007028)