Managing Diabetes Mindfully Study (MDM)

August 10, 2023 updated by: HealthPartners Institute
To evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction (MBSR) program for patients with diabetes (DM) on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life; and to estimate the effect of a MBSR program for patients with DM. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective: Evaluate the feasibility of conducting a trial of a MBSR program for patients with diabetes on measures of HbA1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life. Feasibility will be assessed via: a) the interest of patients in taking part in an MBSR program; c) the effectiveness of strategies for recruiting patients with diabetes into the study; d) rates of participant compliance with the MBSR; and, e) patient compliance with the program evaluation plan.

Estimate the effect of a MBSR program for patients with diabetes. It is expected that MBSR program participants will evidence a trend toward better clinical outcome measures of HbA1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.

Secondary Objective: To explore the experience of people with diabetes who participate in an MBSR course through the use of semi-structured interviews.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55425
        • HealthPartners Institute for Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-80 years of age
  • English speaking
  • have type 2 diabetes, with 2 HbA1C values >8 in prior 16 months
  • HbA1C value of >8 within 3 months of intervention start
  • able to read course materials
  • mentally intact with no history of mental illness or major depression
  • reachable by phone (for phone support component)
  • able to attend weekly classes
  • willing to provide written informed consent

Exclusion Criteria:

  • completed formal training in other mind body practices such as meditation, yoga, or tai chi within the prior year or currently have a regular ongoing practice in this area.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction
Subjects attend a community based Mindfulness-Based Stress Reduction course.
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
An 8-9 week MBSR course led by an experienced instructor in a group format. Participants learn mindfulness meditation techniques and simple yoga exercises. Subjects receive four phone support calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C Blood Test
Time Frame: Baseline and 12-15 weeks from start of intervention period
This HbA1C blood test will be compared to a qualifying HbA1C blood test.
Baseline and 12-15 weeks from start of intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: 8 weeks during intervention
Subjects will self-administer blood pressure testing with a wrist blood pressure cuff and a Daily Log provided to the subject and record results during the intervention period.
8 weeks during intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of diabetes self-management
Time Frame: At baseline and 0 - 3 weeks after completion of the intervention
By self report (survey)
At baseline and 0 - 3 weeks after completion of the intervention
Measure of perceived stress
Time Frame: At baseline and 0 - 3 weeks after completion of the intervention
By self report (survey)
At baseline and 0 - 3 weeks after completion of the intervention
Measure of depression
Time Frame: At baseline and 0 - 3 weeks after completion of the intervention
By self report (survey)
At baseline and 0 - 3 weeks after completion of the intervention
Measure of self-efficacy
Time Frame: At baseline and 0 - 3 weeks after completion of the intervention
By self report (survey)
At baseline and 0 - 3 weeks after completion of the intervention
Measure of quality of life
Time Frame: At baseline and 0 - 3 weeks after completion of the intervention
By self report (survey)
At baseline and 0 - 3 weeks after completion of the intervention
patient evaluation of MBSR intervention
Time Frame: week 12- 15 post baseline measures
semi-structured telephone interviews with subjects evaluating their perception of the value of the intervention on their overall diabetes management; their satisfaction with the intervention; and their perception of the intervention impact on their quality of life
week 12- 15 post baseline measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Investigators

  • Principal Investigator: Robin Whitebird, PhD, HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (Estimated)

February 22, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23AT003919-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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