Remotely Delivered Mindfulness-Based Diabetes Education

NCT06312553 | Not Yet Recruiting

• 2 other identifiers: IRB-300012515P50MD017338
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Type 2 Diabetes

Keywords

Diabetes Distress; Glycemic Control; Remote Patient Monitoring

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  2 months

Study Arms (2)

Experimental: Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring

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.

Behavioral: Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring

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.18 Standard DSME will be delivered in groups of 8-12 participants via Zoom.

Behavioral: Standard Diabetes Self Management Education

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

Experimental: Remotely delivered Mindfulness-Based Diabetes Education with remote patient monitoring

Standard Diabetes Self Management Education BEHAVIORAL

Standard Diabetes Self Management Education described in study arm

Standard Diabetes Self Management Education

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• non-English speaker
• current pregnancy
• diagnosis of a severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Caroline A Presley, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline A Presley, MD, MPH

CONTACT

205-934-7609; capresley@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share