Type 2 DiabetesE-RCTNCT05208164
My ESSENCE - A Research Study on Mindfulness for African-Americans With Type 2 Diabetes
A study testing Mindfunlness Meditation in people with Type 2 Diabetes and Sleep, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The proposed research and training will allow Dr. Alana Biggers to obtain critical research skills and study a mindfulness meditation program designed to improve sleep and reduce stress in African-American adults with diabetes. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Sleep, Stress
- What is being tested?
- Mindfunlness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identifies as African American or Black
- Diagnosis of type 2 diabetes
- Valid address in greater Chicagoland area
- Mobile phone with unlimited text-messaging
- Mobile device (smartphone, tablet, or computer) with the ability to connect to the internet if remote online delivery
- Availability to participate in mindfulness class either in-person or online
- Age 21-75
Who cannot join
- Untreated obstructive sleep apnea (OSA)
- Severe insomnia, narcolepsy, or REM sleep related disorder
- Major cognitive impairments or psychiatric disorder
- Alcohol or drug abuse
- Limited English proficiency
- Inability to send/receive text messages
- Currently engaging in mindfulness practice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alyssa Lawrence contact
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 606012
Arthi Dutta, 312-413-5372, myessence@uic.edu
Alana Biggers, MD, MPH
About this study
Official title: My ESSENCE - Mindfulness to Reduce Stress, Improve SIeep, and Reduce Cardiovascular Risk in African-Americans With Type 2 Diabetes
The proposed research and training will allow Dr. Alana Biggers to obtain critical research skills and study a mindfulness meditation program designed to improve sleep and reduce stress in African-American adults with diabetes. If effective, this program may reduce the risk of cardiovascular disease among African-Americans with type 2 diabetes who are at high risk of cardiovascular disease.
Read the detailed description
African-Americans have disproportionate rates of cardiovascular disease (CVD) in the US. African-Americans with type 2 diabetes (T2DM) have twice the risk than non-Hispanic whites for developing CVD. Poorer sleep and greater chronic psychological stress may contribute to this additional risk. Consequently, African-Americans have worse glycemic control among those with diabetes and higher CVD risk. One promising approach to improving CVD risk in African-Americans is mindfulness meditation (MM). MM can potentially reduce cardiovascular risk through attention control, emotional regulation, and self-awareness. The overall purpose of this K01 training grant is for Dr. Alana Biggers to obtain research training and develop skills needed to become an independent investigator, and use those skills to adapt and evaluate an established MM curriculum. The specific aims are to: (1) adapt and refine an established MM curriculum for African-Americans with T2DM and incorporate text messaging; (2) conduct an 8-week, pilot randomized, controlled trial of the adapted curriculum with up to 100 African-Americans with T2DM(goal of 68 for study completion); and (3) explore the impact of the intervention on cardiometabolic risk factors (blood pressure, glycosylated hemoglobin, and lipid profile) and inflammatory biomarkers (C-reactive protein, interleukin-6, and tumor necrosis factor α). Primary outcomes will include sleep quality and perceived stress evaluated at baseline, 8, and 16 weeks. The proposed research design consists of a pilot study, utilizes mixed-methods research, and involves both primary data collection and analysis. Participants will be randomized 1:1 to either the MM intervention or control. Patients will be assigned to fill cohorts so that those in intervention group will attend MM classes together. A cohort represents a group of 10-12 subjects enrolled within a 1-month time period. MM classes will guide participants in learning and implementing MM practices over 8 weeks. Data collection will occur at baseline, 8 weeks (completion of MM sessions), and 16 weeks. The 16-week data assessment will evaluate MM practice beyond the MM class structure to assess for sustainability.
This K01 training grant will provide Dr. Biggers career-building activities to further develop skills and a knowledge base in quantitative and qualitative methodology, health disparities research, and mobile health (mHealth)/behavioral health strategies in minority populations. With the guidance of an interdisciplinary mentorship team and institutional support, Dr. Biggers will receive the necessary assistance and training to work toward her long-term career goal of being an independent researcher with expertise in health disparities, mixed-methods, and mHealth behavioral research.
- Conditions
- Type 2 Diabetes, Sleep, Stress
- Being tested
- Mindfunlness Meditation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfunlness MeditationBehavioural
Sleep monitoring, mental health promotion and active enrollment/engagement in self-described coping mechanisms
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Classes | Experimental | 8 mindfulness classes: Participants will engage in 8 two-hour mind and body practice classes over 8 weeks in-person or online (during the pandemic). You will receive compensation for your participation and a yoga mat. You will need to wear comfortable clothing. These sessions can be done sitting in chair, sitting on the floor, or standing.
Text messaging., in between classes you will receive text messages to encourage mind and body practices at home. Text messaging may appear as the following:
1.Do you have time to meditate right now? Yes or No. 2.Did you practice your mindfulness today? Yes or no. 3.Remember to wind down this evening and do not drink any caffeinated beverages 4 hours before bed. Receives: Behavioral: Mindfunlness Meditation |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Will use Pittsburgh Sleep Quality Index (PSQI). PSQI has a minimum score of 0 (better) and maximum of 21 (worse). Score > 5 is considered poor quality sleep.
Measured: Change from baseline at 8 and 16 weeks.
Perceived Stress
Will use Perceived Stress Scale. Scale has a minimum value of 0, and maximum value of 40. Scores from 0-13 are considered low stress, 14-26 are moderate, and 27-40 are high perceived stress.
Measured: Change from baseline at 8 and 16 weeks.
Sleep Disturbances
Will use Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. Scores are reported as T-scores, with 28.9 being the minimum value, and 76.5 being the maximum. Higher scores indicate greater sleep disturbances.
Measured: Change from baseline at 8 and 16 weeks
Sleep Impairment
Will use Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a.Scores are reported as T-scores, with 30.0 being the minimum value, and 80.1 being the maximum. Higher scores indicate greater sleep impairment.
Measured: Change from baseline at 8 and 16 weeks
Secondary outcomes (3)
Cardiovascular Risk
Fasting lipid profile (total cholesterol, HDL, LDL and triglycerides) and blood pressure will be combined to estimate 10 year cardiovascular risk using the American College of Cardiology Atherosclerotic Cardiovascular Disease (ACC ASCVD) Risk Estimator Plus Calculator.
Measured: Change from baseline at 8 weeks
Hemoglobin A1c
Will use HbgA1c as a measure for determining cardiovascular risk.
Measured: Change from baseline at 8 weeks.
Inflammatory Markers
IL-6, CRP, TNF-alpha
Measured: Change from baseline at 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Apr 2021
- Primary completion31 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will be assigned as the intervention group and Group B will be assigned as the usual care group. During the pilot RCT, Group A will run in parallel with Group B.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alana Biggers, University of Illinois Chicago
- Investigators
- Alana Biggers, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208164
- Sponsor's protocol ID
- 2019-1433
- Other IDs
- 1K01HL149775
- Acronym
- E-RCT
- Status last verified
- Mar 2025
- First submitted
- 10 Dec 2021
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My ESSENCE - Mindfulness to Reduce Stress, Improve SIeep, and Reduce Cardiovascular Risk in African-Americans With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05208164
- Acronym / sponsor ID
- E-RCT / 2019-1433
- Conditions
- Type 2 Diabetes, Sleep, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research and training will allow Dr. Alana Biggers to obtain critical research skills and study a mindfulness meditation program designed to improve sleep and reduce stress in African-American adults with diabetes. If effective, this program may reduce the risk of cardiovascular disease among African-Americans with type 2 diabetes who are at high risk of cardiovascular disease.
Detailed description
African-Americans have disproportionate rates of cardiovascular disease (CVD) in the US. African-Americans with type 2 diabetes (T2DM) have twice the risk than non-Hispanic whites for developing CVD. Poorer sleep and greater chronic psychological stress may contribute to this additional risk. Consequently, African-Americans have worse glycemic control among those with diabetes and higher CVD risk. One promising approach to improving CVD risk in African-Americans is mindfulness meditation (MM). MM can potentially reduce cardiovascular risk through attention control, emotional regulation, and self-awareness. The overall purpose of this K01 training grant is for Dr. Alana Biggers to obtain research training and develop skills needed to become an independent investigator, and use those skills to adapt and evaluate an established MM curriculum. The specific aims are to: (1) adapt and refine an established MM curriculum for African-Americans with T2DM and incorporate text messaging; (2) conduct an 8-week, pilot randomized, controlled trial of the adapted curriculum with up to 100 African-Americans with T2DM(goal of 68 for study completion); and (3) explore the impact of the intervention on cardiometabolic risk factors (blood pressure, glycosylated hemoglobin, and lipid profile) and inflammatory biomarkers (C-reactive protein, interleukin-6, and tumor necrosis factor α). Primary outcomes will include sleep quality and perceived stress evaluated at baseline, 8, and 16 weeks. The proposed research design consists of a pilot study, utilizes mixed-methods research, and involves both primary data collection and analysis. Participants will be randomized 1:1 to either the MM intervention or control. Patients will be assigned to fill cohorts so that those in intervention group will attend MM classes together. A cohort represents a group of 10-12 subjects enrolled within a 1-month time period. MM classes will guide participants in learning and implementing MM practices over 8 weeks. Data collection will occur at baseline, 8 weeks (completion of MM sessions), and 16 weeks. The 16-week data assessment will evaluate MM practice beyond the MM class structure to assess for sustainability.
This K01 training grant will provide Dr. Biggers career-building activities to further develop skills and a knowledge base in quantitative and qualitative methodology, health disparities research, and mobile health (mHealth)/behavioral health strategies in minority populations. With the guidance of an interdisciplinary mentorship team and institutional support, Dr. Biggers will receive the necessary assistance and training to work toward her long-term career goal of being an independent researcher with expertise in health disparities, mixed-methods, and mHealth behavioral research.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A will be assigned as the intervention group and Group B will be assigned as the usual care group. During the pilot RCT, Group A will run in parallel with Group B.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Classes | Experimental | Behavioral: Mindfunlness Meditation8 mindfulness classes: Participants will engage in 8 two-hour mind and body practice classes over 8 weeks in-person or online (during the pandemic). You will receive compensation for your participation and a yoga mat. You will need to wear comfortable clothing. These sessions can be done sitting in chair, sitting on the floor, or standing. Text messaging., in between classes you will receive text messages to encourage mind and body practices at home. Text messaging may appear as the following: 1.Do you have time to meditate right now? Yes or No. 2.Did you practice your mindfulness today? Yes or no. 3.Remember to wind down this evening and do not drink any caffeinated beverages 4 hours before bed. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Self-identifies as African American or Black
- Diagnosis of type 2 diabetes
- Valid address in greater Chicagoland area
- Mobile phone with unlimited text-messaging
- Mobile device (smartphone, tablet, or computer) with the ability to connect to the internet if remote online delivery
Key exclusion criteria (7 listed)
- Untreated obstructive sleep apnea (OSA)
- Severe insomnia, narcolepsy, or REM sleep related disorder
- Major cognitive impairments or psychiatric disorder
- Alcohol or drug abuse
- Limited English proficiency
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 |
|---|---|---|
| Mindfunlness MeditationSleep monitoring, mental health promotion and active enrollment/engagement in self-described coping mechanisms | Behavioural | Mindfulness Meditation Classes |
Primary outcome
Sleep Quality
Time frame: Change from baseline at 8 and 16 weeks.
Will use Pittsburgh Sleep Quality Index (PSQI). PSQI has a minimum score of 0 (better) and maximum of 21 (worse). Score > 5 is considered poor quality sleep.
Perceived Stress
Time frame: Change from baseline at 8 and 16 weeks.
Will use Perceived Stress Scale. Scale has a minimum value of 0, and maximum value of 40. Scores from 0-13 are considered low stress, 14-26 are moderate, and 27-40 are high perceived stress.
Sleep Disturbances
Time frame: Change from baseline at 8 and 16 weeks
Will use Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8b. Scores are reported as T-scores, with 28.9 being the minimum value, and 76.5 being the maximum. Higher scores indicate greater sleep disturbances.
Sleep Impairment
Time frame: Change from baseline at 8 and 16 weeks
Will use Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a.Scores are reported as T-scores, with 30.0 being the minimum value, and 80.1 being the maximum. Higher scores indicate greater sleep impairment.
3 secondary outcomes
Cardiovascular Risk
Time frame: Change from baseline at 8 weeks
Hemoglobin A1c
Time frame: Change from baseline at 8 weeks.
Inflammatory Markers
Time frame: Change from baseline at 8 and 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Alyssa Lawrence contact
Alana Biggers principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfunlness Meditation in people with Type 2 Diabetes and Sleep, run by University of Illinois Chicago 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alana Biggers, MD, MPH (312-413-1793, abigger2@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Change from baseline at 8 and 16 weeks.). The study lists 4 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 5 Mar 2025.