Mindfulness IN-home for Diabetes and Sleep Health

Not Applicable

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Mindfulness-based stress reduction (MBSR) Intervention

• Registration Number: NCT04160078
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Study Start: 2019-12-18
• Primary Completion: 2021-08-17
• Study Completion: 2021-08-29
• Results First Submitted: 2022-08-18
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Results First Posted: 2022-09-28
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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%)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindfulness Intervention Arm	Mindfulness-based stress reduction (MBSR) Intervention	A stress reduction plus sleep education intervention to improve sleep health

Primary Outcome Measures

Name	Time	Method
Sleep Duration	Baseline, 4 weeks post-intervention	Sleep duration was measured in hours and minutes using a sleep 7-day actigraphy (Philips Respironics Actiwatch Spectrum Plus) on the non-dominant wrist, and confirmed with daily sleep logs. Self-reported sleep duration was also measured.
Number of Participants With PSS Score Indicating Low Stress	Baseline, 4 weeks post-intervention	The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 0 to 13 are categorized as having low stress.
Pittsburgh Sleep Quality Index (PSQI) Score	Baseline, 4 weeks post-intervention	Global sleep quality was measured via the validated Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire which assesses several dimensions of sleep including sleep quality, duration, and disturbances over a 1-month time interval. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score which ranges from 0 to 21. Poor sleep quality is defined as a global score of 5 or greater.
Perceived Stress Scale (PSS)	Baseline, 4 weeks post-intervention	The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress.
Number of Participants With PSS Score Indicating Moderate Stress	Baseline, 4 weeks post-intervention	The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 14 to 26 are categorized as having moderate stress.
Number of Participants With PSS Score Indicating High Stress	Baseline, 4 weeks post-intervention	The perceived stress scale is a validated tool to help understand how different situations affect feelings and perceived stress. The PSS has 10 items which are responded to on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 and higher scores indicate higher perceived stress. Participants with scores of 27 to 40 are categorized as having high stress.

Secondary Outcome Measures

Name	Time	Method
Weight	Baseline, 4 weeks post-intervention	Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants.
Body Mass Index (BMI)	Baseline, 4 weeks post-intervention	Body mass index (BMI) is calculated as weight in kilograms (kg) divided by the square of the body height measured in meters (m). A BMI between 18.5 and 24.9 is considered to be normal weight. A BMI of 25-29.9 indicates overweight, while a BMI of 30 or more indicates obesity.
Blood Pressure	Baseline, 4 weeks post-intervention	Blood pressure is the pressure of circulating blood on the walls of blood vessels and is measured in millimeters of mercury (mmHg). Three seated blood pressure measurements were made using an electronic sphygmomanometer. An average of the last two readings were used to assess systolic and diastolic blood pressure. Blood pressure values of less than 120 mmHg systolic and 80 mmHg diastolic are considered within the normal range.

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States