Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04160078
Recruitment Status : Recruiting
First Posted : November 11, 2019
Last Update Posted : November 11, 2019
Sponsor:
Collaborators:
Georgia Center for Diabetes Translation Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Dayna A. Johnson, 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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Behavioral: Mindfulness-based stress reduction (MBSR) Intervention Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adapting a Mindfulness Intervention to Improve Sleep and Reduce Diabetes Risk Among a Diverse Sample in Atlanta
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Mindfulness Intervention Arm
A stress reduction plus sleep education intervention to improve sleep health
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
Other Name: MBSR Intervention




Primary Outcome Measures :
  1. Change in average nightly sleep duration from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]
    Sleep duration will be measured in hours and minutes using a sleep 7-day actigraphy (Philips Respironics Actiwatch Spectrum Plus) on the non-dominant wrist, and concurrently a sleep diary to facilitates interpretation and assessment of actigraphy

  2. Change in sleep timing from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]
    Change in sleep schedule will be expressed in hours and minutes and recorded using a sleep 7-day actigraphy (Philips Respironics Actiwatch Spectrum Plus) on the non-dominant wrist, and concurrently a sleep diary to facilitates interpretation and assessment of actigraphy

  3. Change in sleep quality from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]

    Sleep quality/efficiency will be measured using a self-reported instrument (Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.I n 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 (range 0 to 21). Higher scores indicate worse sleep quality.

    Poor sleep quality is defined as a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI).



Secondary Outcome Measures :
  1. Change in average high-density lipoproteins (HDL) Cholesterol from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]
    The difference in levels of HDL at baseline and at 7 weeks post-intervention will be measured. HDL are reported in mg/dL and a range of 40 to 59 mg/dL is normal, but it could be higher. Having HDL under 40 mg/dL increases your risk of developing heart disease and stroke.

  2. Change in triglycerides from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]
    The difference in levels of triglycerides in the bloodstream at baseline and at 7 weeks post-intervention will be measured. Triglycerides are reported in mg/dL. Less than 150 milligrams per deciliter is normal, and higher levels of triglycerides have been linked to atherosclerosis, heart disease and stroke.

  3. Change in fasting blood glucose [ Time Frame: Baseline, 7 weeks post-intervention ]
    The difference in fasting blood glucose at baseline and at 7 weeks post-intervention will be measured. Fasting blood glucose is reported in mg/dL. A fasting blood sugar level less than 100 mg/dL is normal. A fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes.

  4. Change in hemoglobin A1c (HbA1c) from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]
    The difference in the levels of HbA1c at baseline and at 7 weeks post-intervention will be measured. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.

  5. Change in Blood pressure from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]

    Blood pressure is the pressure of circulating blood on the walls of blood vessels, and it is measured in mm Hg.

    Three seated blood pressure measurements will be made using an electronic sphygmomanometer. An average of the last two readings will be used to assess systolic and diastolic blood pressure. Blood pressure numbers of less than 120/80 mm Hg are considered within the normal range.


  6. Change in C-reactive protein from baseline [ Time Frame: Baseline, 7 weeks post-intervention ]
    C-reactive protein (CRP) is a protein made by the liver and it is a marker of inflammation in the body. Normal CRP levels are below 3.0 mg/L (the normal reference range often varies between labs). CRP will be assessed at baseline and 7 weeks post intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resident in the Atlanta, GA 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160078


Contacts
Layout table for location contacts
Contact: Kawonda Holland 404-727-8190 kawonda.l.holland@emory.edu
Contact: Dayna Johnson, PhD 404-727-8708 dayna.johnson@emory.edu

Locations
Layout table for location information
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Dayna Johnson, PhD         
Sponsors and Collaborators
Emory University
Georgia Center for Diabetes Translation Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Dayna Johnson, PhD Emory University

Layout table for additonal information
Responsible Party: Dayna A. Johnson, Assistant professor, Emory University
ClinicalTrials.gov Identifier: NCT04160078     History of Changes
Other Study ID Numbers: IRB00112861
P30DK111024 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2019    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Statistical analysis plan will be available upon request. Data will be available one year after the first person is enrolled with no end date.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: One year after the first person is enrolled. No end date.
Access Criteria: Researchers upon request will be able to access data, for any purpose. Data will be shared via secure data transfer.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dayna A. Johnson, Emory University:
Diabetes
Mindfulness
Public health
Sleep
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases