My ESSENCE - A Research Study on Mindfulness for African-Americans With Type 2 Diabetes

NCT ID: NCT05208164

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-07-31

Brief 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. 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.

Conditions

Type 2 Diabetes; Sleep; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Mindfulness Meditation Classes

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.

Group Type: EXPERIMENTAL

Mindfunlness Meditation

Intervention Type: BEHAVIORAL

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

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfunlness Meditation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Alana Biggers

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alana Biggers

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alana Biggers, MD, MPH

Role: CONTACT

abigger2@uic.edu

312-413-1793

Alyssa Lawrence

Role: CONTACT

amlawre2@uic.edu

Facility Contacts

Arthi Dutta

Role: primary

myessence@uic.edu

312-413-5372

Other Identifiers

1K01HL149775

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-1433

Identifier Type: -

Identifier Source: org_study_id