Diabetes, Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Mindfulness, Public health, Sleep
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.
Interventions
* 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
Sponsors
Georgia Center for Diabetes Translation Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Weight | Baseline, 4 weeks post-intervention | Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention Participants receiving a stress reduction plus sleep education intervention to improve sleep health | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Mindfulness-based Stress Reduction (MBSR) Intervention |
|---|---|
| Age, Continuous | 29.89 years STANDARD_DEVIATION 10.16 |
| Education Bachelor's degree | 9 Participants |
| Education Less than Bachelor's degree | 2 Participants |
| Education Professional degree (Master's, MD, PhD, law degree) | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 8 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race White | 6 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: Baseline, 4 weeks post-intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Number of Participants With PSS Score Indicating High Stress | High stress at Baseline | 1 Participants |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Number of Participants With PSS Score Indicating High Stress | High stress at 4 weeks post-intervention | 0 Participants |
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.
Time frame: Baseline, 4 weeks post-intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Number of Participants With PSS Score Indicating Low Stress | Low stress at Baseline | 7 Participants |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Number of Participants With PSS Score Indicating Low Stress | Low stress at 4 weeks post-intervention | 10 Participants |
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.
Time frame: Baseline, 4 weeks post-intervention
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Number of Participants With PSS Score Indicating Moderate Stress | Moderate stress at Baseline | 10 Participants |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Number of Participants With PSS Score Indicating Moderate Stress | Moderate stress at 4 weeks post-intervention | 8 Participants |
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.
Time frame: Baseline, 4 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Perceived Stress Scale (PSS) | Baseline | 15.72 score on a scale | Standard Deviation 7.73 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Perceived Stress Scale (PSS) | 4 weeks post-intervention | 13.44 score on a scale | Standard Deviation 7.47 |
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.
Time frame: Baseline, 4 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Pittsburgh Sleep Quality Index (PSQI) Score | Baseline | 7.22 score on a scale | Standard Deviation 2.96 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Pittsburgh Sleep Quality Index (PSQI) Score | 4 weeks post-intervention | 5.00 score on a scale | Standard Deviation 2.2 |
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.
Time frame: Baseline, 4 weeks post-intervention
Population: Some participants did not complete the 7-day actigraphy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Sleep Duration | 4 weeks post-intervention assessed by actigraphy | 6.18 hours | Standard Deviation 1.45 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Sleep Duration | Baseline assessed by self-report | 8.30 hours | Standard Deviation 1.33 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Sleep Duration | Baseline assessed by actigraphy | 6.19 hours | Standard Deviation 1.05 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Sleep Duration | 4 weeks post-intervention assessed by self-report | 8.15 hours | Standard Deviation 1.82 |
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.
Time frame: Baseline, 4 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Blood Pressure | Systolic blood pressure at Baseline | 110.03 mmHg | Standard Deviation 11.13 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Blood Pressure | Systolic blood pressure at 4 weeks post-intervention | 112.47 mmHg | Standard Deviation 8.9 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Blood Pressure | Diastolic blood pressure at Baseline | 70.31 mmHg | Standard Deviation 8.14 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Blood Pressure | Diastolic blood pressure at 4 weeks post-intervention | 71.06 mmHg | Standard Deviation 6.99 |
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.
Time frame: Baseline, 4 weeks post-intervention
Population: One participant did not report weight at the 4 weeks post-intervention assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Body Mass Index (BMI) | 4 weeks post-assessment | 30.21 kg/m^2 | Standard Deviation 5.27 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Body Mass Index (BMI) | Baseline | 29.93 kg/m^2 | Standard Deviation 5.22 |
Secondary
Weight
Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants.
Time frame: Baseline, 4 weeks post-intervention
Population: One participant did not report weight at the 4 week post-intervention assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness-based Stress Reduction (MBSR) Intervention | Weight | Baseline | 180.64 pounds | Standard Deviation 30 |
| Mindfulness-based Stress Reduction (MBSR) Intervention | Weight | 4 weeks post-intervention | 184.12 pounds | Standard Deviation 29.77 |