Resilience-Based Diabetes Education for Type 2 Diabetes

(TXSTRIDE Trial)

Overseen By Christian Pfeiffer Flores, CRA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must not be taking: Glucocorticoids

Disqualifiers: Pregnancy, Heart disease, Kidney failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

284 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Mary A. Steinhardt, EdD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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

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

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

Treatment Details

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.

Participant Groups

Group I: Resilience-Based Diabetes Self-Management Education Experimental Treatment 1 Intervention

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 II: Standard Diabetes Self-Management Education Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+