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Completed

NCT Number: NCT01796834

Managing Diabetes Mindfully Study

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Institute for Education and Research

Bloomington, Minnesota, 55425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Measures of diabetes self-management

    Time frame: At baseline and 0 - 3 weeks after completion of the intervention

    By self report (survey)

  2. Measure of perceived stress

    Time frame: At baseline and 0 - 3 weeks after completion of the intervention

    By self report (survey)

  3. Measure of depression

    Time frame: At baseline and 0 - 3 weeks after completion of the intervention

    By self report (survey)

  4. Measure of self-efficacy

    Time frame: At baseline and 0 - 3 weeks after completion of the intervention

    By self report (survey)

  5. Measure of quality of life

    Time frame: At baseline and 0 - 3 weeks after completion of the intervention

    By self report (survey)

  6. 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

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Acronym: MDM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2013
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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