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

NCT05208164 | Recruiting

• 2 other identifiers: 2019-14331K01HL149775
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Sleep; Stress

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Change from baseline at 8 and 16 weeks

Secondary Outcomes (3)

• Cardiovascular Risk

  Change from baseline at 8 weeks

• Hemoglobin A1c

  Change from baseline at 8 weeks.

• Inflammatory Markers

  Change from baseline at 8 and 16 weeks

Study Arms (2)

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.

Behavioral: Mindfunlness Meditation

Usual Care

NO INTERVENTION

Interventions

Mindfunlness Meditation BEHAVIORAL

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

Mindfulness Meditation Classes

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 606012, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alana Biggers

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alana Biggers, MD, MPH

CONTACT

312-413-1793; abigger2@uic.edu

Alyssa Lawrence

CONTACT

amlawre2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: January 26, 2022
• Study Start: April 1, 2021
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)