Mindfulness IN-home for Diabetes and Sleep Health

NCT ID: NCT04160078

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2021-08-29

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindfulness Intervention Arm

A stress reduction plus sleep education intervention to improve sleep health

Group Type: EXPERIMENTAL

Mindfulness-based stress reduction (MBSR) Intervention

Intervention Type: BEHAVIORAL

• 1-hour session on sleep hygiene and 7-week follow up using a mindfulness app, an app that features guided meditation and can be used to assess adherence.
• Sleep log diary: self report of sleep records
• Wrist Actigraphy, to monitor sleep patterns. Participants will be instructed on wearing the sleep monitor (Spectrum, Philips Respironics, Murrysville, PA) on their non-dominant wrist for the next 7-weeks

Interventions

Mindfulness-based stress reduction (MBSR) Intervention

• 1-hour session on sleep hygiene and 7-week follow up using a mindfulness app, an app that features guided meditation and can be used to assess adherence.
• Sleep log diary: self report of sleep records
• Wrist Actigraphy, to monitor sleep patterns. Participants will be instructed on wearing the sleep monitor (Spectrum, Philips Respironics, Murrysville, PA) on their non-dominant wrist for the next 7-weeks

Intervention Type: BEHAVIORAL

Other Intervention Names

MBSR Intervention

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Georgia Center for Diabetes Translation Research

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Dayna A. Johnson

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dayna Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30DK111024

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00112861

Identifier Type: -

Identifier Source: org_study_id