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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age 19 years or older
* diagnosis of type 2 diabetes
* Black race (self-report)
* receipt of care at one of the study sites with one or more visits to within the prior year
* presence of elevated diabetes distress (score ≥2 on Diabetes Distress Scale indicating moderate-severe distress)
* uncontrolled diabetes indicated by an elevated hemoglobin A1c (A1C) ≥8%
Exclusion Criteria (Presence of any of the following criteria):
* non-English speaker
* current pregnancy
* diagnosis of a severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on testing whether the study design itself is workable — not yet on proving the program works — so what does that mean for me in terms of knowing whether mindfulness-based diabetes education will actually benefit my blood sugar or health outcomes?
2The program is delivered remotely and involves regular home mindfulness practices and self-monitoring tasks, so given my current schedule and comfort with technology, do you think I'd realistically be able to keep up with those demands?
3Since this study isn't recruiting yet, is there a timeline for when it might open, and in the meantime, are there existing diabetes education or mindfulness programs I could start now that cover similar ground?
4The trial is measuring things like why people drop out and what barriers get in the way of participation — does that tell us anything about how demanding or difficult past programs like this have been for patients like me?
5Would you recommend I consider this kind of mindfulness-based approach alongside or instead of other diabetes management options you'd normally suggest, and what would help us decide which path makes more sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility: percentage of screened participants who are eligible
Timeframe: 6 months
2
Feasibility: percentage of eligible participants who enroll
Timeframe: 6 months
3
Feasibility: ability to randomize participants to study arms
Timeframe: 6 months
4
Feasibility: distribution of participants by demographics
Timeframe: 6 months
5
Feasibility: percentage of sessions attended
Timeframe: 6 months
6
Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities.
Timeframe: 6 months
7
Feasibility: barriers to participation in intervention sessions or completing study activities at home