Type 2 DiabetesNCT06312553
Remotely Delivered Mindfulness-Based Diabetes Education
A study testing Remotely delivered Mindfulness-Based Diabetes Education and Standard Diabetes Self Management Education in people with Type 2 Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Remotely delivered Mindfulness-Based Diabetes Education and Standard Diabetes Self Management Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UAB
Birmingham, Alabama, 35294
Caroline Presley, MD, 205-934-7609, capresley@uabmc.edu
About this study
Official title: Remotely Delivered Mindfulness-Based Diabetes Education for Rural Adults With Uncontrolled Diabetes and Elevated Distress
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.
Read the detailed description
For Aim 2, investigators will conduct a pilot randomized controlled trial (RCT) comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in rural, Black adults with uncontrolled type 2 diabetes and elevated diabetes distress. Pilot RCT participants will be recruited from Federally Qualified Health Centers in the rural Black Belt region of Alabama. Participants will be recruited through opt-out letters and phone calls to adults with diabetes seen within the preceding two years at study sites, as well as through in-person recruitment during clinic or through direct referral by provider or patient.
Investigators plan to recruit up to 80 participants total, 40 per study arm. Investigators will obtain screening consent prior to conducting screening diabetes distress and A1C (per previously described inclusion criteria). Informed consent will be obtained from eligible participants prior to enrollment or randomization. Participants will be randomly assigned to receive either Mindfulness-Based Diabetes Education or standard Diabetes Self-Management Education on a 1:1 basis; randomization will be stratified by study site and sex.
The Mindfulness-Based Diabetes Education intervention will be delivered remotely by Zoom videoconference in 8 weekly sessions in a group setting. Following completion of the 8-week program, participants will receive 2 bimonthly individual booster sessions by phone for a total duration of 6 months. Mindfulness-Based Diabetes Education will be delivered by an interventionist, who is a nurse practitioner with clinical expertise in diabetes care and education as well as training in MBSR. During intervention sessions, participants will be introduced to different mindfulness practices, including awareness of breath meditation, body scan exercise, walking meditation, and mindful yoga, and informal practices including the application of mindfulness to daily activities. Additionally, participants will receive instruction and have opportunities to practice bringing mindful attention to specific diabetes self-management behaviors. For example, a session will include exploration of mind-body connections, instruction of walking meditation, educational module on physical activity (PA), and a PA exercise with mindful attention. Participants will be asked to complete daily home mindfulness exercises and self-monitoring of diabetes self-management behaviors. Mindfulness-Based Diabetes Education will use incremental goal setting with self-monitoring, feedback, and modeling to build participants' self-efficacy and on development of social support. Sessions will include time for participants to set SMART goals. Additionally, participants in the intervention arm will receive a glucometer and kit to facilitate remote monitoring of blood glucose. Participants will be instructed to measure blood glucose levels at least 1 time per day.
Standard DSME will be delivered by a Certified Diabetes Educator remotely by Zoom videoconference in 4 biweekly, 2-hour sessions. DSME sessions will cover seven core content areas including healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.
The primary outcomes of the study will be acceptability and feasibility. Participants in the Mindfulness-Based Diabetes Education arm will be asked to participate in a semi-structured interview to assess the acceptability of the intervention including participants' perspectives on intervention content; perceived benefits or negative effects of the intervention; appropriateness of intervention duration and frequency; satisfaction with interventionist; satisfaction with intervention content; barriers to engagement; suggestions to improve the intervention; and overall satisfaction. Feasibility of delivering Mindfulness-Based Diabetes Education will be assessed through process measures including: percentage of screened participants who are eligible; percentage of eligible participants who enroll; ability to randomize participants to study arms; representativeness of participants by age, gender, and race/ethnicity; number of sessions attended; participant adherence to study tasks, including home mindfulness exercises and self-monitoring of diabetes self-management behaviors; barriers to participation in intervention sessions or completing study activities at home; reasons for dropping out; and overall study retention. This study will also provide an opportunity to test the feasibility of recruitment strategies, allocation procedures, and assessment procedures and measures.
Participants will complete assessments at baseline and 6 months, which will include an interviewer-administered questionnaire of participant characteristics and validated measures of stress and diabetes distress, mood, diabetes self-management behaviors, self-efficacy, social needs, and health related-quality of life Participants will have height and weight measured, as well as point-of-care hemoglobin A1c (A1C) testing at baseline and 6 months. Outcome assessors will be blinded to the study arm to which participants are assigned.
- Conditions
- Type 2 Diabetes
- Being tested
- Remotely delivered Mindfulness-Based Diabetes Education, Standard Diabetes Self Management Education
- Keywords
- Diabetes Distress, Glycemic Control, Remote Patient Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely delivered Mindfulness-Based Diabetes EducationBehavioural
Remotely delivered Mindfulness-Based Diabetes Education described in study arm
Standard Diabetes Self Management EducationBehavioural
Standard Diabetes Self Management Education described in study arm
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Remotely delivered Mindfulness-Based Diabetes Education | Experimental | 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. Receives: Behavioral: Remotely delivered Mindfulness-Based Diabetes Education |
| Standard Diabetes Self Management Education | Active comparator | 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. Standard DSME will be delivered in groups of 8-12 participants via Zoom. Receives: Behavioral: Standard Diabetes Self Management Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: percentage of screened participants who are eligible
Investigators will assess the percentage of screened participants who are eligible to participate in the study. Study staff will track the number of participants who are screened for participation and the number of participants who are eligible to participate.
Measured: 6 months
Feasibility: percentage of eligible participants who enroll
Investigators will assess the percentage of eligible participants who enroll in the study. Study staff will track the number of participants who are eligible for participation and the number of participants who enroll in the study.
Measured: 6 months
Feasibility: ability to randomize participants to study arms
Investigators will assess the percentage of eligible participants who are randomized. Study staff will track the number of participants who are enrolled and the number of participants who are randomized.
Measured: 6 months
Feasibility: distribution of participants by demographics
Investigators will collect demographics of study participants, including age and gender by participant self-report. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer. Investigators will use descriptive statistics to characterize the demographics of the study sample.
Measured: 6 months
Feasibility: percentage of sessions attended
Investigators will track the number of sessions attended by each participant and calculate the percentage of sessions attended by each participant.
Measured: 6 months
Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities.
At each session, Investigators will collect logs of participants' home mindfulness and self-monitoring activities. Investigators will calculate participant adherence to recommended activities for each participant.
Measured: 6 months
Feasibility: barriers to participation in intervention sessions or completing study activities at home
Investigators will collect information from participants to assess any barriers they experienced attending study sessions or completing recommended home activities. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer.
Measured: 6 months
Feasibility: reasons for dropping out
Investigators will collect information from participants who drop out of the intervention or study regarding the reason for dropping out.
Measured: 6 months
Feasibility: overall study retention
Investigators will track the number of participants who enroll in the study and complete assessments at each time point - baseline, 2 months, and 6 months.
Measured: 6 months
Acceptability
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants. Including: perceived positive and negative effects, assessment of intervention content, appropriateness of duration and frequency, satisfaction with interventionist, barriers to engaging with intervention sessions or content, suggestions to improve the intervention
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start31 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Caroline Presley, University of Alabama at Birmingham
- Investigators
- Caroline A Presley, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312553
- Sponsor's protocol ID
- IRB-300012515
- Other IDs
- P50MD017338
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Delivered Mindfulness-Based Diabetes Education for Rural Adults With Uncontrolled Diabetes and Elevated Distress
- ClinicalTrials.gov ID
- NCT06312553
- Acronym / sponsor ID
- IRB-300012515
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes Distress, Glycemic Control, Remote Patient Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For Aim 2, investigators will conduct a pilot randomized controlled trial (RCT) comparing Mindfulness-Based Diabetes Education to standard Diabetes Self-Management Education in rural, Black adults with uncontrolled type 2 diabetes and elevated diabetes distress. Pilot RCT participants will be recruited from Federally Qualified Health Centers in the rural Black Belt region of Alabama. Participants will be recruited through opt-out letters and phone calls to adults with diabetes seen within the preceding two years at study sites, as well as through in-person recruitment during clinic or through direct referral by provider or patient.
Investigators plan to recruit up to 80 participants total, 40 per study arm. Investigators will obtain screening consent prior to conducting screening diabetes distress and A1C (per previously described inclusion criteria). Informed consent will be obtained from eligible participants prior to enrollment or randomization. Participants will be randomly assigned to receive either Mindfulness-Based Diabetes Education or standard Diabetes Self-Management Education on a 1:1 basis; randomization will be stratified by study site and sex.
The Mindfulness-Based Diabetes Education intervention will be delivered remotely by Zoom videoconference in 8 weekly sessions in a group setting. Following completion of the 8-week program, participants will receive 2 bimonthly individual booster sessions by phone for a total duration of 6 months. Mindfulness-Based Diabetes Education will be delivered by an interventionist, who is a nurse practitioner with clinical expertise in diabetes care and education as well as training in MBSR. During intervention sessions, participants will be introduced to different mindfulness practices, including awareness of breath meditation, body scan exercise, walking meditation, and mindful yoga, and informal practices including the application of mindfulness to daily activities. Additionally, participants will receive instruction and have opportunities to practice bringing mindful attention to specific diabetes self-management behaviors. For example, a session will include exploration of mind-body connections, instruction of walking meditation, educational module on physical activity (PA), and a PA exercise with mindful attention. Participants will be asked to complete daily home mindfulness exercises and self-monitoring of diabetes self-management behaviors. Mindfulness-Based Diabetes Education will use incremental goal setting with self-monitoring, feedback, and modeling to build participants' self-efficacy and on development of social support. Sessions will include time for participants to set SMART goals. Additionally, participants in the intervention arm will receive a glucometer and kit to facilitate remote monitoring of blood glucose. Participants will be instructed to measure blood glucose levels at least 1 time per day.
Standard DSME will be delivered by a Certified Diabetes Educator remotely by Zoom videoconference in 4 biweekly, 2-hour sessions. DSME sessions will cover seven core content areas including healthy eating, physical activity, medication usage, self-monitoring, preventing and treating acute and chronic complications, healthy coping, and problem solving.
The primary outcomes of the study will be acceptability and feasibility. Participants in the Mindfulness-Based Diabetes Education arm will be asked to participate in a semi-structured interview to assess the acceptability of the intervention including participants' perspectives on intervention content; perceived benefits or negative effects of the intervention; appropriateness of intervention duration and frequency; satisfaction with interventionist; satisfaction with intervention content; barriers to engagement; suggestions to improve the intervention; and overall satisfaction. Feasibility of delivering Mindfulness-Based Diabetes Education will be assessed through process measures including: percentage of screened participants who are eligible; percentage of eligible participants who enroll; ability to randomize participants to study arms; representativeness of participants by age, gender, and race/ethnicity; number of sessions attended; participant adherence to study tasks, including home mindfulness exercises and self-monitoring of diabetes self-management behaviors; barriers to participation in intervention sessions or completing study activities at home; reasons for dropping out; and overall study retention. This study will also provide an opportunity to test the feasibility of recruitment strategies, allocation procedures, and assessment procedures and measures.
Participants will complete assessments at baseline and 6 months, which will include an interviewer-administered questionnaire of participant characteristics and validated measures of stress and diabetes distress, mood, diabetes self-management behaviors, self-efficacy, social needs, and health related-quality of life Participants will have height and weight measured, as well as point-of-care hemoglobin A1c (A1C) testing at baseline and 6 months. Outcome assessors will be blinded to the study arm to which participants are assigned.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Remotely delivered Mindfulness-Based Diabetes Education | Experimental | Behavioral: Remotely delivered Mindfulness-Based Diabetes EducationThe 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. |
| Standard Diabetes Self Management Education | Active comparator | Behavioral: Standard Diabetes Self Management EducationStandard 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. Standard DSME will be delivered in groups of 8-12 participants via Zoom. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remotely delivered Mindfulness-Based Diabetes EducationRemotely delivered Mindfulness-Based Diabetes Education described in study arm | Behavioural | Experimental: Remotely delivered Mindfulness-Based Diabetes Education |
| Standard Diabetes Self Management EducationStandard Diabetes Self Management Education described in study arm | Behavioural | Standard Diabetes Self Management Education |
Primary outcome
Feasibility: percentage of screened participants who are eligible
Time frame: 6 months
Investigators will assess the percentage of screened participants who are eligible to participate in the study. Study staff will track the number of participants who are screened for participation and the number of participants who are eligible to participate.
Feasibility: percentage of eligible participants who enroll
Time frame: 6 months
Investigators will assess the percentage of eligible participants who enroll in the study. Study staff will track the number of participants who are eligible for participation and the number of participants who enroll in the study.
Feasibility: ability to randomize participants to study arms
Time frame: 6 months
Investigators will assess the percentage of eligible participants who are randomized. Study staff will track the number of participants who are enrolled and the number of participants who are randomized.
Feasibility: distribution of participants by demographics
Time frame: 6 months
Investigators will collect demographics of study participants, including age and gender by participant self-report. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer. Investigators will use descriptive statistics to characterize the demographics of the study sample.
Feasibility: percentage of sessions attended
Time frame: 6 months
Investigators will track the number of sessions attended by each participant and calculate the percentage of sessions attended by each participant.
Feasibility: participant adherence to study tasks include home mindfulness practices, self-monitoring activities.
Time frame: 6 months
At each session, Investigators will collect logs of participants' home mindfulness and self-monitoring activities. Investigators will calculate participant adherence to recommended activities for each participant.
Feasibility: barriers to participation in intervention sessions or completing study activities at home
Time frame: 6 months
Investigators will collect information from participants to assess any barriers they experienced attending study sessions or completing recommended home activities. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer.
Feasibility: reasons for dropping out
Time frame: 6 months
Investigators will collect information from participants who drop out of the intervention or study regarding the reason for dropping out.
Feasibility: overall study retention
Time frame: 6 months
Investigators will track the number of participants who enroll in the study and complete assessments at each time point - baseline, 2 months, and 6 months.
Acceptability
Time frame: 2 months
Will be assessed through focus groups with participants after they have completed the 8-weekly intervention sessions for MBDE. Interviews will be recorded and transcribed. A combined inductive/deductive approach will be used for qualitative analysis, to identify themes reported by participants. Including: perceived positive and negative effects, assessment of intervention content, appropriateness of duration and frequency, satisfaction with interventionist, barriers to engaging with intervention sessions or content, suggestions to improve the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline A Presley, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely delivered Mindfulness-Based Diabetes Education and Standard Diabetes Self Management Education in people with Type 2 Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline A Presley, MD, MPH (205-934-7609, capresley@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: percentage of screened participants who are eligible (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.