Resilience-Based Diabetes Education for Type 2 Diabetes

(TXSTRIDE Trial)

HP
CP
Overseen ByChristian Pfeiffer Flores, CRA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas at Austin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help African Americans with type 2 diabetes manage their condition through a program that combines resilience-building with diabetes self-care education. Participants will attend classes and support sessions that focus on coping with stress and making healthy lifestyle choices. The trial compares this approach, known as Resilience-Based Diabetes Self-Management Education, to standard diabetes management education. It suits African Americans with type 2 diabetes who are not currently in any other management program. As an unphased trial, this study offers a unique opportunity to explore innovative strategies for diabetes management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use glucocorticoid medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that this resilience-based education program is safe for diabetes management?

Research has shown that the Resilience-Based Diabetes Self-Management Education (RB-DSME) program enhances resilience, including confidence in managing diabetes and social support. This program combines these strengths with practical skills for handling diabetes. Current information does not specify any safety issues or side effects related to this educational approach.

The program is non-invasive and likely easy to manage. It includes classes and support sessions instead of medication or medical procedures. Such educational programs usually carry very low risks. Participants can expect to focus on learning and support, which aim to improve diabetes management and overall well-being.12345

Why are researchers excited about this trial?

Researchers are excited about Resilience-Based Diabetes Self-Management Education (RB-DSME) for Type 2 Diabetes because it offers a fresh approach to managing the condition by building on foundational resilience resources like self-efficacy and social support. Unlike traditional diabetes education, RB-DSME introduces novel elements such as adaptation to stress, finding positive meaning, and spiritual coping, which could provide a more holistic strategy for individuals managing their diabetes. This method aims to empower patients not just by educating them about diabetes management, but by enhancing their overall resilience, potentially leading to better long-term outcomes.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that Resilience-Based Diabetes Self-Management Education (RB-DSME), one of the treatment arms in this trial, can help manage type 2 diabetes, particularly for African Americans. This trial will compare RB-DSME to Standard Diabetes Self-Management Education to evaluate its effectiveness. Studies have found RB-DSME promising for improving both physical and mental health. This program helps people handle stress and find positive meaning in their experiences. Participants learn important skills like believing in their ability to succeed and receive social support. These elements aim to help patients maintain healthy lifestyle choices, which can lessen the negative effects of diabetes over time.12346

Who Is on the Research Team?

MA

Mary A. Steinhardt, EdD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for African American adults over 18 with Type 2 Diabetes Mellitus (T2DM), who have an A1C level of 6.5 or higher and are not currently in another T2DM management program. Pregnant/lactating individuals, those with certain medical conditions, or those on glucocorticoid medication cannot participate.

Inclusion Criteria

Your A1C level must be 6.5 or higher.
I have been diagnosed with type 2 diabetes.
Participants must not be currently participating in another T2DM management program
See 6 more

Exclusion Criteria

I do not use any medication that contains glucocorticoids.
I do not have any health conditions that prevent me from changing my diet or exercising.
Individuals will be excluded if they are pregnant/lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 10-month intervention consisting of 8 weekly educational sessions, 8 bimonthly support group sessions, and 2 booster sessions

10 months
18 sessions (in-person)

Follow-up

Participants are monitored for changes in T2DM physical and mental health outcomes at 6, 12, and 24 months

14 months

What Are the Treatments Tested in This Trial?

Interventions

  • Resilience-Based Diabetes Self-Management Education
  • Standard Diabetes Self-Management Education
Trial Overview The study compares Resilience-Based Diabetes Self-Management Education (RB-DSME) to Standard Diabetes Self-Management Education among African Americans. It aims to integrate resilience resources with diabetes self-management skills to improve health outcomes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Resilience-Based Diabetes Self-Management EducationExperimental Treatment1 Intervention
Group II: Standard Diabetes Self-Management EducationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials
387
Recruited
86,100+

Citations

Resilience-Based Diabetes Self-Management Education (RB ...The purpose of this qualitative, focus group study was to further refine the Resilience-Based Diabetes Self-Management Education (RB-DSME) recruitment process ...
Resilience-Based Diabetes Self-Management Education ...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 ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/28614997/
Resilience-based Diabetes Self-management EducationThe purpose of this qualitative, focus group study was to further refine the Resilience-based Diabetes Self-management Education (RB-DSME) recruitment process ...
Resilience-Based Diabetes Self-Management EducationPDF | Purpose The purpose of this qualitative, focus group study was to further refine the Resilience-based Diabetes Self-management Education (RB-DSME).
Comparative effectiveness of diabetes self-management ...Effectiveness of group-based self-management education for individuals with type 2 diabetes: a systematic review with meta-analyses and meta-regression.
Resilience-Based Diabetes Education for Type 2 ...It aims to integrate resilience resources with diabetes self-management skills to improve health outcomes. How Is the Trial Designed? 2Treatment groups.
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