Mindfulness IN-home for Diabetes and Sleep Health

Diabetes Mellitus, Type 2 Clinical Trial

— MINDS  

Official title:

Adapting a Mindfulness Intervention to Improve Sleep and Reduce Diabetes Risk Among a Diverse Sample in Atlanta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04160078
• Other study ID #: IRB00112861
• Secondary ID: P30DK111024
• Status: Completed
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: August 29, 2021

Study information

• Verified date: September 2022
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 29, 2021
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI) Score	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.	Baseline, 4 weeks post-intervention
Primary	Sleep Duration	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.	Baseline, 4 weeks post-intervention
Primary	Perceived Stress Scale (PSS)	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.	Baseline, 4 weeks post-intervention
Primary	Number of Participants With PSS Score Indicating Low Stress	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.	Baseline, 4 weeks post-intervention
Primary	Number of Participants With PSS Score Indicating Moderate Stress	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.	Baseline, 4 weeks post-intervention
Primary	Number of Participants With PSS Score Indicating High Stress	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.	Baseline, 4 weeks post-intervention
Secondary	Weight	Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants.	Baseline, 4 weeks post-intervention
Secondary	Body Mass Index (BMI)	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.	Baseline, 4 weeks post-intervention
Secondary	Blood Pressure	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.	Baseline, 4 weeks post-intervention