- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04160078
Mindfulness IN-home for Diabetes and Sleep Health (MINDS)
Adapting a Mindfulness Intervention to Improve Sleep and Reduce Diabetes Risk Among a Diverse Sample in Atlanta
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Georgia
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Atlanta, Georgia, United States, 30322
- Emory University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Mindfulness Intervention Arm
A stress reduction plus sleep education intervention to improve sleep health
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI) Score
Time Frame: 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.
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Baseline, 4 weeks post-intervention
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Sleep Duration
Time Frame: Baseline, 4 weeks post-intervention
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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.
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Baseline, 4 weeks post-intervention
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Perceived Stress Scale (PSS)
Time Frame: Baseline, 4 weeks post-intervention
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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.
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Baseline, 4 weeks post-intervention
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Number of Participants With PSS Score Indicating Low Stress
Time Frame: Baseline, 4 weeks post-intervention
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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.
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Baseline, 4 weeks post-intervention
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Number of Participants With PSS Score Indicating Moderate Stress
Time Frame: Baseline, 4 weeks post-intervention
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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.
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Baseline, 4 weeks post-intervention
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Number of Participants With PSS Score Indicating High Stress
Time Frame: 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.
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Baseline, 4 weeks post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Baseline, 4 weeks post-intervention
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Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants.
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Baseline, 4 weeks post-intervention
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Body Mass Index (BMI)
Time Frame: Baseline, 4 weeks post-intervention
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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.
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Baseline, 4 weeks post-intervention
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Blood Pressure
Time Frame: Baseline, 4 weeks post-intervention
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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.
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Baseline, 4 weeks post-intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dayna Johnson, PhD, Emory University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00112861
- P30DK111024 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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