Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Diabetes distress is common affecting over one-third of people with type 2 diabetes, negatively impacting self-management and outcomes, and disproportionately affecting low-income individuals. The proposed project will conduct a pilot randomized controlled trial comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in adults with type 2 diabetes and elevated diabetes distress who receive care within safety-net healthcare systems in order to assess feasibility and acceptability.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 70
Healthy Volunteers: f
View:

• Age 19-70 years

• Diagnosis of type 2 diabetes (based on the presence of two or more outpatient International Classification of Diseases (ICD-10) codes for type 2 diabetes

• Receipt of care at Cooper Green Mercy Health Systems Authority or Alabama Regional Medical Services (one or more visits to primary care or diabetes clinic within the prior year

• Presence of moderate-severe diabetes distress (score ≥2 on Diabetes Distress Scale

• Suboptimal glycemic control (elevated hemoglobin A1c (A1C) ≥7.5%)

Locations
United States
Alabama
Cooper Green Mercy Health Systems
RECRUITING
Birmingham
Contact Information
Primary
Caroline A Presley, MD, MPH
capresley@uabmc.edu
205-934-7609
Time Frame
Start Date: 2023-05-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 96
Treatments
Experimental: Mindfulness-Based Diabetes Education
Mindfulness-Based Diabetes Education (MBDE) will be delivered in-person in a group of 10-14 participants during 8 weekly sessions followed by 2 bimonthly individual sessions. Sessions integrate Mindfulness-Based Stress Reduction and Diabetes Self-Management Education. MBDE will introduce breath awareness meditation, body scan, walking meditation, mindful yoga, and applying mindfulness to daily activities, as well as core areas from DSME. MBDE will include incremental goal setting to build participants' self-efficacy for diabetes self-management behaviors, mindful attention to diabetes self-management, and on development of social support in the group. Participants will complete daily home mindfulness exercises and self-monitoring of diabetes self-management behaviors.
Active_comparator: Standard Diabetes Self-Management Education
Standard DSME will be delivered in-person, in a group setting with 10-14 participants per group. Standard DSME will be delivered by a certified diabetes educator in eight weekly sessions of 2 hours duration. Sessions will cover seven core content areas - healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov