Managing Diabetes Mindfully Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

• Registration Number: NCT01796834
• Lead Sponsor: HealthPartners Institute

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.

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Stress Reduction	Mindfulness-Based Stress Reduction (MBSR)	Subjects attend a community based Mindfulness-Based Stress Reduction course.

Primary Outcome Measures

Name	Time	Method
HbA1C Blood Test	Baseline and 12-15 weeks from start of intervention period	This HbA1C blood test will be compared to a qualifying HbA1C blood test.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	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.

Trial Locations

Locations (1)

HealthPartners Institute for Education and Research; 🇺🇸 Bloomington, Minnesota, United States