Remotely Delivered Mindfulness-Based Diabetes Education

Sponsor
University of Alabama at Birmingham
Study ID
NCT06312553
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring — BEHAVIORAL
    Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring described in study arm
  • Standard Diabetes Self Management Education — BEHAVIORAL
    Standard Diabetes Self Management Education described in study arm

Study Details

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 remotely delivered Mindfulness-Based Diabetes Education plus remote patient monitoring of blood glucose to standard Diabetes Self-Management Education in rural Black adults with type 2 diabetes and elevated diabetes distress who receive care within federally qualified health centers to assess feasibility and acceptability.

Key Dates

First listed
Mar 15, 2024
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Experimental: Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring
    The Mindfulness-Based Diabetes Education (MBDE) program will be delivered in 8, 2-hour weekly sessions, then 2 booster sessions, total duration of 6 months. MBDE will be delivered over Zoom with content delivered by the interventionist per the program manual. Participants will be provided with a tablet and WIFI hotspot. Sessions will be video-recorded and made available to participants in case of missed sessions.
  • Active Comparator: Standard Diabetes Self Management Education
    Standard DSME will be delivered by a certified diabetes educator in four biweekly sessions of 2 hours duration; topics will include healthy eating, physical activity, medication usage, self-monitoring, preventing and managing complications, healthy coping, and problem solving.18 Standard DSME will be delivered in groups of 8-12 participants via Zoom.

Primary Outcome Measure

Feasibility: percentage of screened participants who are eligible [ Time Frame: 6 months ]

Central Contacts

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