Managing Diabetes Mindfully Study

Diabetes Mellitus Clinical Trial

— MDM  

Official title:

Managing Diabetes Mindfully Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796834
• Other study ID #: K23AT003919-01A2
• Secondary ID: K23AT003919-01A2
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	HealthPartners Institute for Education and Research	Bloomington	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measures of diabetes self-management	By self report (survey)	At baseline and 0 - 3 weeks after completion of the intervention
Other	Measure of perceived stress	By self report (survey)	At baseline and 0 - 3 weeks after completion of the intervention
Other	Measure of depression	By self report (survey)	At baseline and 0 - 3 weeks after completion of the intervention
Other	Measure of self-efficacy	By self report (survey)	At baseline and 0 - 3 weeks after completion of the intervention
Other	Measure of quality of life	By self report (survey)	At baseline and 0 - 3 weeks after completion of the intervention
Other	patient evaluation of MBSR intervention	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
Primary	HbA1C Blood Test	This HbA1C blood test will be compared to a qualifying HbA1C blood test.	Baseline and 12-15 weeks from start of intervention period
Secondary	Blood Pressure	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