Clinical trial NCT04160078: Mindfulness IN-home for Diabetes and Sleep Health
Official title: Adapting a Mindfulness Intervention to Improve Sleep and Reduce Diabetes Risk Among a Diverse Sample in Atlanta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Diabetes Mellitus, Type 2
Keywords: Diabetes
Mindfulness
Public health
Sleep
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Center for Diabetes Translation Research
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-11-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study investigates the effects of a mindfulness intervention on sleep and subsequent cardio-metabolic risk in an adult Atlanta population aged 18 and older.

Detailed description: Type 2 diabetes mellitus has been identified as a leading cause of death in the United States. This problem is alarmingly higher in southern state, including Georgia. Sleep, a modifiable health behavior, may be a target for reducing the burden of diabetes. This research study will enroll adults from the community to participate in a mindfulness-based stress reduction program (MBSR) via an app on his/her cellular phone. Participants will also wear a wrist monitor to estimate activity and sleep as well as provide a blood sample before and after the MBSR. Following the 6-week intervention program, participants will provide information via focus groups to obtain feedback on his/her experiences during the program.

This pilot study will enroll (N=20) racially diverse men and women who are 18 years and older and reside in Atlanta. Participants will be recruited from the community via advertisements, community events and existing community partnerships. Trained research assistants will screen potential participants. Eligible participants will be contacted via phone and scheduled to attend a baseline visit to collect a blood sample and attend a sleep education session.

Eligibility criteria: Inclusion Criteria:

* Resident in the Atlanta, Georgia area
* Proficient in English
* Have a smartphone
* Sleep quality score \>5 on the validated Pittsburgh Sleep Quality Index
* Prediabetes (defined as fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%)

Exclusion Criteria:

* Pregnant women
* Sleep quality score less than a score 5 on the validated Pittsburgh Sleep Quality Index
* Refusal to download Mindfulness mobile application
* Diagnosis of HIV, AIDS, Liver disease (diagnosed, i.e. chronic or alcoholic hepatitis, cirrhosis), Renal/Kidney disease
* Current Cocaine, heroin, or methamphetamines use and/or has a history of treatment for alcohol or drug abuse
* Pre-diabetes: defined as a score greater than 3 on the American Diabetes Association 60-Second Type 2 Diabetes Risk Test

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Baseline, 4 weeks post-intervention
measure: Sleep Duration
timeFrame: Baseline, 4 weeks post-intervention
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, 4 weeks post-intervention
measure: Number of Participants With PSS Score Indicating Low Stress
timeFrame: Baseline, 4 weeks post-intervention
measure: Number of Participants With PSS Score Indicating Moderate Stress
timeFrame: Baseline, 4 weeks post-intervention
measure: Number of Participants With PSS Score Indicating High Stress
timeFrame: Baseline, 4 weeks post-intervention
Secondary outcomes:
measure: Weight
timeFrame: Baseline, 4 weeks post-intervention
measure: Body Mass Index (BMI)
timeFrame: Baseline, 4 weeks post-intervention
measure: Blood Pressure
timeFrame: Baseline, 4 weeks post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Dayna Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: