Resilience-Based Diabetes Self-Management Education (RB-DSME) for African Americans (TXSTRIDE)

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Type 2 Diabetes

Treatments: Behavioral: Standard Diabetes Self-Management Education; Behavioral: Resilience-Based Diabetes Self-Management Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04282395

R01DK123146

Details and patient eligibility

About

African Americans are twice as likely to have type 2 diabetes as non-Hispanic Whites and are less likely to engage in effective diabetes self-management. There is a critical need for intensive lifestyle interventions that address the distress inherent in having the disease and the unique stressors faced by African Americans that may worsen diabetes-related health outcomes. Our program, Resilience-Based Diabetes Self-Management Education and Support, integrates resilience resources with diabetes self-management skills to enable African-American patients to manage the daily demands of the disease and improve long-term adherence to healthy lifestyle choices, thereby reducing the negative health burden of diabetes.

Full description

Type 2 diabetes mellitus (T2DM) costs the U.S. $327 billion annually, representing a 26% increase from 2012 to 2017. African Americans (AAs) are twice as likely to have T2DM as non-Hispanic Whites, have worse health outcomes, and are less likely to engage in self-management behaviors. Interventions addressing these disparities are urgently needed. Among AAs, T2DM-associated stress is often compounded by general life stress, which further constrains diabetes self-management and is associated with poor glucose control (A1C) and complications such as depression. The impact of stress on diabetes self-management and health outcomes may be attenuated by resilience: a resolve to succeed despite adversities. Even with evidence supporting resilience resources benefiting other health outcomes, there is a dearth of evidence-based T2DM resilience interventions. Building on our promising pilot work, this study uses our culturally tailored, theory-derived Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention to help participants manage the psychosocial and behavioral demands of the disease. The study is designed as a 24-month, 2-arm, cluster randomized clinical trial and involves assigning AA churches to the RB-DSME or a standard DSME condition. Both groups receive a 10-month intervention: 8 weekly educational sessions, followed by 8 bimonthly support group sessions, followed by 2 booster sessions. To investigate the efficacy of RB-DSME, we compare RB-DSME to DSME on T2DM physical and mental health outcomes. To inform more targeted future interventions, we examine indirect effects of RB-DSME (vs DSME) on resilience resources, such as stress and coping. We also examine indirect effects of resilience resources on T2DM health outcomes through self-management behaviors, such as diet and exercise.

The specific aims of the study are:

Aim 1: To compare T2DM physical health outcomes (primary outcome: A1C) and T2DM mental health outcomes (primary outcome: depressive symptoms) in the RB-DSME group vs DSME group at 6, 12, and 24 months.

H1: Compared with DSME, RB-DSME will have improved T2DM physical health outcomes.

H2: Compared with DSME, RB-DSME will have improved T2DM mental health outcomes.

Aim 2: To test indirect effects of RB-DSME (vs DSME) on T2DM physical and mental health outcomes via resilience resources, self-management behaviors, and HPA axis function.

H3: RB-DSME (vs DSME) will improve resilience resources at 6 and 12 months, which will improve T2DM physical and mental health outcomes at 12 and 24 months.

H4: RB-DSME (vs DSME) driven improvements in resilience resources at 6 months will improve self-management and HPA axis function at 12 months, which will improve T2DM outcomes at 24 months.

The project will provide crucial guidance for addressing the T2DM burden among AAs by establishing the efficacy of the RB-DSME and identifying behavioral and biological mechanisms by which the program affects T2DM health outcomes. The long-term goal is to enable AAs to effectively manage T2DM and thus avoid its serious consequences, via RB-DSME interventions in a range of community settings.

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Participants must:

• be African American;
• be diagnosed with T2DM;
• be 18 years of age or older;
• have an A1C of 6.5 or higher; and
• not be currently participating in another T2DM management program.

Exclusion Criteria: Individuals will be excluded if they:

• are pregnant/lactating;
• have medical conditions for which changes in diet and/or physical activity would be contraindicated (e.g., hospitalization for heart disease during the past 6 months, diagnosed heart failure, kidney failure, or peripheral vascular disease requiring special diets and/or restricted physical activity severe enough to preclude walking three times per week, or active tuberculosis); or
• use glucocorticoid containing medication.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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284 participants in 2 patient groups

Resilience-Based Diabetes Self-Management Education

Experimental group

Description:

The RB-DSME structure involves 8 weekly classes, 8 bimonthly support group sessions, and 2 booster sessions. The RB-DSME builds on foundational resilience resources (e.g., self-efficacy, social support), infusing novel resilience resources (e.g., adaptation to stress, finding positive meaning, spiritual coping) into the RB-DSME curriculum.

Treatment:

Behavioral: Resilience-Based Diabetes Self-Management Education

Standard Diabetes Self-Management Education

Active Comparator group

Description:

The scope and sequence of the standard diabetes self-management education (DSME) curriculum are aligned with national standards of the American Diabetes Association. DSME groups receive a 10-month intervention: 8 weekly educational sessions, followed by 8 bimonthly support group sessions, followed by 2 booster sessions.

Treatment:

Behavioral: Standard Diabetes Self-Management Education