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NCT Number: NCT05208164

My ESSENCE - A Research Study on Mindfulness for 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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 606012, United States

Location status: Recruiting

Location contact

Alana Biggers, MD, MPH

PRINCIPAL_INVESTIGATOR

Arthi Dutta

CONTACT

[email protected]

312-413-5372

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mindfunlness Meditation

Behavioral

Sleep monitoring, mental health promotion and active enrollment/engagement in self-described coping mechanisms

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Cardiovascular Risk

    Time frame: Change from baseline at 8 weeks

    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.

  2. Hemoglobin A1c

    Time frame: Change from baseline at 8 weeks.

    Will use HbgA1c as a measure for determining cardiovascular risk.

  3. Inflammatory Markers

    Time frame: Change from baseline at 8 and 16 weeks

    IL-6, CRP, TNF-alpha

Study contacts

Contact information is provided by the study sponsor or research team.

Alana Biggers, MD, MPH

CONTACT

[email protected]

312-413-1793

Alyssa Lawrence

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

My ESSENCE - Mindfulness to Reduce Stress, Improve SIeep, and Reduce Cardiovascular Risk in African-Americans With Type 2 Diabetes

Acronym: E-RCT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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