Ignite Creation Date:
2025-12-24 @ 1:52 PM
Ignite Modification Date:
2025-12-24 @ 1:52 PM
Study NCT ID:
NCT04282395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2020-02-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Resilience-Based Diabetes Self-Management Education (RB-DSME) for African Americans
Sponsor:
University of Texas at Austin
Organization:
Study Overview
Official Title:
Improving Health Outcomes in African Americans With Type 2 Diabetes: A Culturally Tailored, Resilience-Based Diabetes Self-Management Education (RB-DSME) Intervention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TXSTRIDE
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: