Mindfulness-Based Diabetes Education for Adults With Elevated Diabetes Distress

NCT05195138 | Completed DMC

• 1 other identifier: IRB-300008617
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 2 Diabetes

Keywords

Diabetes distress; Mindfulness-based diabetes education

Outcome Measures

Primary Outcomes (16)

• Participant assessment of perceived positive and negative effects

  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.

  2 months

• Participant assessment of intervention content

  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.

  2 months

• Participant assessment of appropriateness of intervention duration and frequency

  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.

  2 months

• Participant satisfaction with interventionist

  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.

  2 months

• Participant-reported barriers to engagement with the intervention sessions or content

  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.

  2 months

• Participants' suggestions to improve the intervention

  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.

  2 months

• Participants' overall satisfaction with the intervention

  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.

  2 months

• Feasibility: percentage of screened participants who are eligible

  We 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

  We 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

  We 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

  We will collect demographics of study participants, including age, race, ethnicity, and gender by participant self-report. This information will be obtained during a questionnaire administered to participants in English by a trained interviewer. We will use descriptive statistics to characterize the demographics of the study sample.

  6 months

• Feasibility: percentage of sessions attended

  We 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, we will collect logs of participants' home mindfulness and self-monitoring activities. We 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

  We 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

  We 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

  We 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

Secondary Outcomes (38)

• Hemoglobin A1c

  Baseline

• Hemoglobin A1c

  6 months

• Diabetes distress

  Baseline

• Diabetes distress

  2 months

• Diabetes distress

  6 months

Study Arms (2)

Mindfulness-Based Diabetes Education

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Diabetes Education

Standard Diabetes Self-Management Education

ACTIVE COMPARATOR

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.

Behavioral: Standard Diabetes Self-Management Education (DSME)

Interventions

Standard Diabetes Self-Management Education (DSME) BEHAVIORAL

Standard DSME described in study arm.

Standard Diabetes Self-Management Education

Mindfulness-Based Diabetes Education BEHAVIORAL

Mindfulness-Based Diabetes Education described in study arm.

Mindfulness-Based Diabetes Education

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• Non-English speaking
• Currently pregnant
• Diagnosis of severe psychiatric comorbidity including bipolar disorder, schizophrenia, or a history of psychosis (based on participant self-report)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Cooper Green Mercy Health Systems

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Caroline A Presley, MD, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 18, 2022
• Study Start: May 31, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)