Mindfulness IN-home for Diabetes and Sleep Health (MINDS)

Emory University

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Behavioral: Mindfulness-based stress reduction (MBSR) Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04160078

P30DK111024 (U.S. NIH Grant/Contract)

IRB00112861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Mindfulness Intervention Arm

Experimental group

Description:

A stress reduction plus sleep education intervention to improve sleep health

Treatment:

Behavioral: Mindfulness-based stress reduction (MBSR) Intervention