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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-25

Study Completion Date

2025-04-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

All study participants receive a behavioral intervention that is aimed at managing their diabetes condition, either a standard diabetes self-management education intervention or the experimental resilience-based diabetes self-management education intervention. Due to the nature of behavioral interventions, we are only able to mask the participants, care providers, and dietary recall outcome assessors.

Study Groups

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Resilience-Based Diabetes Self-Management Education

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.

Group Type EXPERIMENTAL

Resilience-Based Diabetes Self-Management Education

Intervention Type BEHAVIORAL

During the group sessions led by professional nurses, participants are provided information and group activities to enable them to more effectively manage their personal diabetes challenges. During the support group sessions, participants discuss personal challenges and solutions to diabetes self-management, using a more informal approach. Booster sessions are held to refresh participants' understanding of how resilience resources can sustain self-management behaviors and maintain improved T2DM health outcomes. The RB-DSME also incorporates cultural characteristics and preferences of African Americans (AAs), to include:

* the location in community-based church settings,
* recognition of cultural dietary preferences, and
* emphasis on cultural/historical significance of resilience in AAs.

Standard Diabetes Self-Management Education

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.

Group Type ACTIVE_COMPARATOR

Standard Diabetes Self-Management Education

Intervention Type BEHAVIORAL

Control group sessions, led by professional nurses, cover topics such as:

* causes and symptoms of type 2 diabetes,
* glucose self-monitoring,
* models for and principles of healthy eating, grocery shopping and dining out,
* physical activity,
* diabetes medications,
* managing sick days and stress, and
* community resources.

Interventions

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Resilience-Based Diabetes Self-Management Education

During the group sessions led by professional nurses, participants are provided information and group activities to enable them to more effectively manage their personal diabetes challenges. During the support group sessions, participants discuss personal challenges and solutions to diabetes self-management, using a more informal approach. Booster sessions are held to refresh participants' understanding of how resilience resources can sustain self-management behaviors and maintain improved T2DM health outcomes. The RB-DSME also incorporates cultural characteristics and preferences of African Americans (AAs), to include:

* the location in community-based church settings,
* recognition of cultural dietary preferences, and
* emphasis on cultural/historical significance of resilience in AAs.

Intervention Type BEHAVIORAL

Standard Diabetes Self-Management Education

Control group sessions, led by professional nurses, cover topics such as:

* causes and symptoms of type 2 diabetes,
* glucose self-monitoring,
* models for and principles of healthy eating, grocery shopping and dining out,
* physical activity,
* diabetes medications,
* managing sick days and stress, and
* community resources.

Intervention Type BEHAVIORAL

Other Intervention Names

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RB-DSME DSME

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No