An Innovative Approach With Group Counseling and Mindfulness Training Among Prediabetes Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Clemson University
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Intervention Attendance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Only Arm
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
Intervention: Mindfulness Based Stress Reduction (Behavioral)
Outcomes
Primary Outcomes
Intervention Attendance
Time Frame: 8-weeks while completing the intervention
How many hours of intervention sessions an individual attended
Secondary Outcomes
- Depression(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- Medication Adherence(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- Perceived Stress Scale(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- Perceived Health Status(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- Physical Activity(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- Mindfulness(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- Program satisfaction and barriers for attending sessions(Immediately following intervention)
- Anxiety(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- Sleep Quality(Up to 3 months before intervention, immediately following intervention, one month after intervention)
- HbA1C levels(Up to 3 months before intervention, immediately following intervention, one month after intervention)
Investigators
Heidi Zinzow
Professor of Psychology
Clemson University