A comparative effectiveness study of two culturally competent models of diabetes self-management programming for Latinos from low-income households.

BACKGROUND: Diabetes risk is extremely high for Latinos from low-income households. Health guidelines recommend that individuals learn strategies to self-manage their diabetes, but getting people to adopt required lifestyle changes is challenging and many people are not able to prevent their pre-diabetes from escalating or effectively control their diabetes. Systematic reviews show that culturally competent self-management programs can significantly improve diabetes outcomes and different models for culturally competent programming have been developed.

METHODS: This patient-engaged study will compare the effectiveness of two distinct evidence-based models for culturally competent diabetes health promotion at two sites that serve a large Latino patient population from low-income households: 1) The Diabetes Self-Management Support Empowerment Model, an educational session approach, and 2) The Chronic Care Model, a holistic community-based program. Data collection will involve interviews, focus groups, surveys and assessments of each program; and testing of patient participants for A1c, depression, Body Mass Index (BMI), and chronic stress with hair cortisol levels. We will recruit a total of 240 patient-social support pairs: Patients will be adults (men and women over the age of 18) who: 1.) Enter one of the two diabetes programs during the study; 2.) Self-identify as "Latino;" 3.) Are able to identify a social support person or key member of their social network who also agrees to participate with them; 4.) Are not pregnant (participants who become pregnant during the study will be excluded); and 5.) Have household income 250% of the Federal Poverty Level (FPL) or below. Social supports will be adults who are identified by the patient participants.

PRIMARY OUTCOME: Improved capacity for diabetes self-management measured through improvements in diabetes knowledge and diabetes-related patient activation.

SECONDARY OUTCOME: Successful diabetes self-management as measured by improvements in A1c, depression scale scores, BMI, and circulating levels of cortisol to determine chronic stress.

DISCUSSION: Our hypothesis is that the program model that interfaces most synergistically with patients' culture and everyday life circumstances will have the best diabetes health outcomes.

TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov on December 16, 2016 (Registration # NCT03004664 ).