Diabetes MellitusMDMNCT01796834
Managing Diabetes Mindfully Study
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Diabetes Mellitus, run by HealthPartners Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- reachable by phone (for phone support component)
- able to attend weekly classes
- willing to provide written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Institute for Education and Research
Bloomington, Minnesota, 55425
About this 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Mindfulness-Based Stress Reduction, Diabetes Management, Stress Reduction, Diabetes Testing
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Subjects attend a community based Mindfulness-Based Stress Reduction course. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C Blood Test
This HbA1C blood test will be compared to a qualifying HbA1C blood test.
Measured: Baseline and 12-15 weeks from start of intervention period
Secondary outcomes (1)
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.
Measured: 8 weeks during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Whitebird, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796834
- Sponsor's protocol ID
- K23AT003919-01A2
- Other IDs
- K23AT003919-01A2
- Acronym
- MDM
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2013
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Whitebird RR, Kreitzer MJ, Vazquez-Benitez G, Enstad CJ. Reducing diabetes distress and improving self-management with mindfulness. Soc Work Health Care. 2018 Jan;57(1):48-65. doi: 10.1080/00981389.2017.1388898. Epub 2017 Oct 24.
PubMed 29064772
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Diabetes Mindfully Study
- ClinicalTrials.gov ID
- NCT01796834
- Acronym / sponsor ID
- MDM / K23AT003919-01A2
- Conditions
- Diabetes Mellitus
- Keywords
- Mindfulness-Based Stress Reduction, Diabetes Management, Stress Reduction, Diabetes Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR)Subjects attend a community based Mindfulness-Based Stress Reduction course. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Mindfulness-Based Stress Reduction |
Primary outcome
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.
1 secondary outcome
Blood Pressure
Time frame: 8 weeks during intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 29064772Whitebird RR, Kreitzer MJ, Vazquez-Benitez G, Enstad CJ. Reducing diabetes distress and improving self-management with mindfulness. Soc Work Health Care. 2018 Jan;57(1):48-65. doi: 10.1080/00981389.2017.1388898. Epub 2017 Oct 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Whitebird, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Diabetes Mellitus, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C Blood Test (time frame: Baseline and 12-15 weeks from start of intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01796834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.