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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Prisma Health-Upstate | OTHER |
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Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.
This is a pilot study to examine the feasibility of integrating a mindfulness-based stress reduction (MBSR) intervention in addition to an existing group-based, peer supported clinical care model (JUMP) among patients with pre-diabetes or diabetes using a mixed-method design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only Arm | Experimental | This is a single-arm, paired-sample pilot intervention study among participants with pre-diabetes or diabetes. Goal to integrate a MBSR intervention into a group-based, lifestyle intervention among patients with prediabetes or diabetes in the primary care setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction | Behavioral | Mindfulness Based Stress Reduction (MBSR) is a well-documented approach to reduce participants' stress level [19], with the existing group-based peer support, self-empowerment, and lifestyle counseling intervention. MBSR is a type of meditation therapy with the goal of actively cultivating conscious attention and awareness to enhance health benefits. This included 10 hours of intervention with groups of 3-5 people. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Attendance | How many hours of intervention sessions an individual attended | 8-weeks while completing the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | Change in perceived stress measured by 4 Items to assess perceived stress where higher levels indicating higher levels of stress with a range of 4 to 20. | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lu Shi, PhD | Clemson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29605 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018149 | Glucose Intolerance |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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This is a single-arm, paired-sample pilot intervention study.
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|
Change in depression scores from the Center for Epidemiologic Studies Depression Scale (CES-D), where higher scores indicate higher levels of depression with a range of 0 to 80. |
| Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Anxiety | Change in anxiety assessed using the Generalized anxiety disorder 7-item scale (GAD-7). | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Medication Adherence | Change in medication adherence assessed using the 8-item Morisky Medication Adherence Scale. A higher score indicates higher adherence with a range of 0 to 8. | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Perceived Health Status | Change in perceived health status assessed using a question asking participants to rate their health status on a 5-points rating scale where lower ratings indicate higher levels of perceived health status and higher ratings indicate lower levels of perceived health status. | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Sleep Quality | Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) ranges from 7 to 28, with higher scores indicating worse sleep quality. | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Physical Activity | Change in physical activity assessed using the Rapid Assessment of Physical Activity Scale (RAPA). | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Mindfulness | Change in Mindfulness assessed using a 15-item Five-Facet Mindfulness Questionnaire (FFMQ). | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| HbA1C levels | HbA1C blood levels | Up to 3 months before intervention, immediately following intervention, one month after intervention |
| Program satisfaction and barriers for attending sessions | Open ended questions to address engagement in the intervention, perceived usefulness of the MBSR, recommendations for intervention modification, what participants enjoyed most/least about the intervention, and reasons for missing intervention sessions. This is a qualitative measure, not numeric values were assigned. Based on Zgierska A, Rabago D, Zuelsdorff M, Coe C, Miller M, Fleming M. Mindfulness meditation for alcohol relapse prevention: a feasibility pilot study. J Addict Med. 2008 Sep;2(3):165-73. doi: 10.1097/ADM.0b013e31816f8546. | Immediately following intervention |
| D006943 | Hyperglycemia |
| D001519 | Behavior |
| D004191 |
| Behavioral Disciplines and Activities |