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Managing Diabetes Mindfully Study (MDM)

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HealthPartners Institute

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type

Interventional

Funder types

Other

Identifiers

NCT01796834
K23AT003919-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

38 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

38 participants in 1 patient group

Mindfulness-Based Stress Reduction
Experimental group
Description:
Subjects attend a community based Mindfulness-Based Stress Reduction course.
Treatment:
Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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