DiabetesMINDSNCT04160078
Mindfulness IN-home for Diabetes and Sleep Health
A study testing Mindfulness-based stress reduction (MBSR) Intervention in people with Diabetes and Diabetes Mellitus, Type 2, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Mindfulness-based stress reduction (MBSR) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 29 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adapting a Mindfulness Intervention to Improve Sleep and Reduce Diabetes Risk Among a Diverse Sample in Atlanta
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.
Read the 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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- Mindfulness-based stress reduction (MBSR) Intervention
- Keywords
- Diabetes, Mindfulness, Public health, Sleep
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction (MBSR) InterventionBehavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Intervention Arm | Experimental | A stress reduction plus sleep education intervention to improve sleep health Receives: Behavioral: Mindfulness-based stress reduction (MBSR) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: Baseline, 4 weeks post-intervention
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.
Measured: 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.
Measured: Baseline, 4 weeks post-intervention
Secondary outcomes (3)
Weight
Participants provided their weight in pounds (lbs) based on a scale that was distributed to participants.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start18 Dec 2019
- Primary completion17 Aug 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Dayna A. Johnson, Emory University
- Investigators
- Dayna Johnson, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160078
- Sponsor's protocol ID
- IRB00112861
- Other IDs
- P30DK111024
- Acronym
- MINDS
- Status last verified
- Sep 2022
- First submitted
- 8 Nov 2019
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Statistical analysis plan will be available upon request. Data will be available one year after the first person is enrolled with no end date.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting a Mindfulness Intervention to Improve Sleep and Reduce Diabetes Risk Among a Diverse Sample in Atlanta
- ClinicalTrials.gov ID
- NCT04160078
- Acronym / sponsor ID
- MINDS / IRB00112861
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Mindfulness, Public health, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Center for Diabetes Translation Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Intervention Arm | Experimental | Behavioral: Mindfulness-based stress reduction (MBSR) InterventionA stress reduction plus sleep education intervention to improve sleep health |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reduction (MBSR) InterventionAlso: 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 | Behavioural | Mindfulness Intervention Arm |
Primary outcome
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.
Sleep Duration
Time frame: 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.
Perceived Stress Scale (PSS)
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.
Number of Participants With PSS Score Indicating Low 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 0 to 13 are categorized as having low stress.
Number of Participants With PSS Score Indicating Moderate 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 14 to 26 are categorized as having moderate stress.
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.
3 secondary outcomes
Weight
Time frame: Baseline, 4 weeks post-intervention
Body Mass Index (BMI)
Time frame: Baseline, 4 weeks post-intervention
Blood Pressure
Time frame: Baseline, 4 weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Statistical analysis plan will be available upon request. Data will be available one year after the first person is enrolled with no end date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dayna Johnson, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction (MBSR) Intervention in people with Diabetes and Diabetes Mellitus, Type 2, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI) Score (time frame: Baseline, 4 weeks post-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.