Prisma Health
Greenville, South Carolina, 29605, United States
NCT Number: NCT04702477
Examining a number of health outcomes in those with diabetes and prediabetes before and after a group-based mindfulness intervention.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Greenville, South Carolina, 29605, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8-weeks while completing the intervention
How many hours of intervention sessions an individual attended
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Up to 3 months before intervention, immediately following intervention, one month after intervention
HbA1C blood levels
Time frame: 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.
Clemson University
Other
An Innovative Approach With Group Counseling and Mindfulness Training Among Prediabetes Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03258138
Behavior, Chronic Disease
Hamilton, Ontario, Canada
View Trial DetailsNCT04705779
Body Weight, Brain Diseases
Chapel Hill, North Carolina, United States
View Trial DetailsNCT06667804
Diabetes, Diabetes Mellitus
Malatya, Turkey (Türkiye)
View Trial DetailsNCT04620668
Anxiety, Anxiety Disorders
Saint John, New Brunswick, Canada
View Trial Details