Clinical trial NCT04282395: Resilience-Based Diabetes Self-Management Education (RB-DSME) for African Americans
Official title: Improving Health Outcomes in African Americans With Type 2 Diabetes: A Culturally Tailored, Resilience-Based Diabetes Self-Management Education (RB-DSME) Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes self-management
Church setting
African Americans
Health disparities
Resilience
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2020-02-24
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The primary goal of the project is to test the efficacy of a resilience-based diabetes self-management education intervention (RB-DSME) using a longitudinal, randomized control group design. Thirty-two AA churches are randomly assigned to the RB-DSME experimental group or a standard diabetes self-management education (DSME) control group, run in 8 cohorts over a 5-year period. Each cohort includes 4 churches (2 intervention, 2 control) with 10 participants in each group, run concurrently. Experimental and control groups participate in 8 weekly 1.5-hour classes, followed by 8 bimonthly (every other week) 1.5-hour support group sessions, followed by 2 every other month 1.5-hour booster sessions. Data are collected at baseline and also at 6 and 12 months post study entry; the specific diabetes-related outcomes are also measured at 24 months.

During the in-person pause in research due to the pandemic, the intervention groups are held via Zoom and will continue in that format.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change from baseline in glycosylated hemoglobin (A1C) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in glycosylated hemoglobin (A1C) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in glycosylated hemoglobin (A1C) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in depressive symptoms at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in depressive symptoms at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in depressive symptoms at 24 months
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Change from baseline in dietary intake at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in dietary intake at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in physical activity at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in physical activity at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in diabetes self-care at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in diabetes self-care at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in physiological stress (HPA axis function) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in physiological stress (HPA axis function) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in fasting blood glucose levels at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in fasting blood glucose levels at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in fasting blood glucose levels at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in cholesterol levels at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in cholesterol levels at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in cholesterol levels at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in triglycerides at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in triglycerides at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in triglycerides at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in body mass index (BMI) at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in body mass index (BMI) at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in body mass index (BMI) at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in waist circumference at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in waist circumference at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in waist circumference at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in blood pressure at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in blood pressure at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in blood pressure at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in diabetes distress at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in diabetes distress at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in diabetes distress at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in general perceived stress at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in general perceived stress at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in general perceived stress at 24 months
timeFrame: Baseline and 24 months
measure: Change from baseline in sleep quantity and quality at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in sleep quantity and quality at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in spiritual coping at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in spiritual coping at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in self-efficacy at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in self-efficacy at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in finding positive meaning at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in finding positive meaning at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in adaptive coping strategies at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in adaptive coping strategies at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in adaptation to stress at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in adaptation to stress at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in coping with discrimination at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in coping with discrimination at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in emotional regulation at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in emotional regulation at 12 months
timeFrame: Baseline and 12 months
measure: Change from baseline in social support at 6 months
timeFrame: Baseline and 6 months
measure: Change from baseline in social support at 12 months
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Mary A. Steinhardt, EdD
role: PRINCIPAL_INVESTIGATOR
References: