Resilience-Based Diabetes Self-Management Education (RB-DSME) for African Americans
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Double (Participant, Care Provider)Masking Description: 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.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT04282395
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Mary A. Steinhardt, EdD University of Texas at Austin Principal Investigator: Sharon A. Brown, PhD University of Texas at Austin
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