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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK111024 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Georgia Center for Diabetes Translation Research | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Intervention Arm | Experimental | A stress reduction plus sleep education intervention to improve sleep health |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based stress reduction (MBSR) Intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Number of Participants With PSS Score Indicating Moderate Stress |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants. | Baseline, 4 weeks post-intervention |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dayna Johnson, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
Statistical analysis plan will be available upon request. Data will be available one year after the first person is enrolled with no end date.
One year after the first person is enrolled. No end date.
Researchers upon request will be able to access data, for any purpose. Data will be shared via secure data transfer.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-based Stress Reduction (MBSR) Intervention | Participants receiving a stress reduction plus sleep education intervention to improve sleep health |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-based Stress Reduction (MBSR) Intervention | Participants receiving a stress reduction plus sleep education intervention to improve sleep health |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 weeks post-intervention |
|
Information on adverse events was collected beginning at the time of participant consent through the follow up visit at 4 weeks post-intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-based Stress Reduction (MBSR) Intervention | Participants receiving a stress reduction plus sleep education intervention to improve sleep health |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash from sleep monitor wrist band | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dayna Johnson, PhD, MPH, MSW, MS | Emory University | 404-727-8708 | dayna.johnson@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2021 | Aug 17, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2019 | Nov 9, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| D008722 | Methods |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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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. |
| Baseline, 4 weeks post-intervention |
| 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 |
| Baseline, 4 weeks post-intervention |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Some participants did not complete the 7-day actigraphy assessment. | Posted | Mean | Standard Deviation | hours | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Baseline, 4 weeks post-intervention |
|
|
|
| Secondary | Weight | Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants. | One participant did not report weight at the 4 week post-intervention assessment. | Posted | Mean | Standard Deviation | pounds | 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. | One participant did not report weight at the 4 weeks post-intervention assessment. | Posted | Mean | Standard Deviation | kg/m^2 | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, 4 weeks post-intervention |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
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| D004191 |
| Behavioral Disciplines and Activities |
| D008919 | Investigative Techniques |
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| Baseline assessed by self-report |
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| 4 weeks post-intervention assessed by self-report |
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| Diastolic blood pressure at 4 weeks post-intervention |
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