Clinical trial NCT04702477: Mindfulness Training and Group Counseling Among Prediabetes and Diabetes Patients
Official title: An Innovative Approach With Group Counseling and Mindfulness Training Among Prediabetes Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Diabetes
Pre-Diabetes
Health Behavior
Quality of Life
Keywords: Stress
Mindfulness
Diabetes
Pre-Diabetes
Lead sponsor: Clemson University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Prisma Health-Upstate
First posted: 2021-01-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm, paired-sample pilot intervention study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention Attendance
timeFrame: 8-weeks while completing the intervention
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Depression
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Anxiety
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Medication Adherence
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Perceived Health Status
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Sleep Quality
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Physical Activity
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Mindfulness
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: HbA1C levels
timeFrame: Up to 3 months before intervention, immediately following intervention, one month after intervention
measure: Program satisfaction and barriers for attending sessions
timeFrame: Immediately following intervention
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Clemson University
name: Lu Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References: