Managing Diabetes Mindfully Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- HealthPartners Institute
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- HbA1C Blood Test
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Blood Pressure(8 weeks during intervention)