Diabetes, Health Behavior, Pre-Diabetes, Quality of Life, Stress
Conditions
Keywords
Stress, Mindfulness, Diabetes, Pre-Diabetes
Brief summary
Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.
Detailed description
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.
Interventions
BEHAVIORALMindfulness Based Stress Reduction
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.
Sponsors
University of California, Los Angeles
Prisma Health-Upstate
Clemson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a single-arm, paired-sample pilot intervention study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * English speaking * Having a diagnosis of diabetes or prediabetes * Participation in a previous group-based clinical care model-JUMP (as in JUMPing into Diabetes Control)
Exclusion criteria
* Under 18 years old * Non-English Speaking * not having a diagnosis of diabetes or prediabetes * No participation in JUMP model
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Attendance | 8-weeks while completing the intervention | How many hours of intervention sessions an individual attended |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Up to 3 months before intervention, immediately following intervention, one month after intervention | 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. |
| Anxiety | Up to 3 months before intervention, immediately following intervention, one month after intervention | Change in anxiety assessed using the Generalized anxiety disorder 7-item scale (GAD-7). |
| Medication Adherence | Up to 3 months before intervention, immediately following intervention, one month after intervention | 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. |
| Perceived Health Status | Up to 3 months before intervention, immediately following intervention, one month after intervention | 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. |
| Perceived Stress Scale | Up to 3 months before intervention, immediately following intervention, one month after intervention | 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. |
| Physical Activity | Up to 3 months before intervention, immediately following intervention, one month after intervention | Change in physical activity assessed using the Rapid Assessment of Physical Activity Scale (RAPA). |
| Mindfulness | Up to 3 months before intervention, immediately following intervention, one month after intervention | Change in Mindfulness assessed using a 15-item Five-Facet Mindfulness Questionnaire (FFMQ). |
| HbA1C levels | Up to 3 months before intervention, immediately following intervention, one month after intervention | HbA1C blood levels |
| Program satisfaction and barriers for attending sessions | Immediately following intervention | 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. |
| Sleep Quality | Up to 3 months before intervention, immediately following intervention, one month after intervention | Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI) ranges from 7 to 28, with higher scores indicating worse sleep quality. |
Countries
United States
Outcome results
None listed