Recruiting

Mindfulness

Sponsor:

University of Illinois at Chicago

Code:

NCT05208164

Conditions

Type 2 Diabetes

Sleep

Stress

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Mindfunlness Meditation

Study Details

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

Study ID

NCT05208164

Start date

Apr 1, 2021

Status verified date

Mar, 2025

Completion date

Jul 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Usual Care

Interventions

Mindfunlness Meditation

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

Primary outcome measure

  • Sleep Quality [ Time Frame: Change from baseline at 8 and 16 weeks. ]
  • Perceived Stress [ Time Frame: Change from baseline at 8 and 16 weeks. ]
  • Sleep Disturbances [ Time Frame: Change from baseline at 8 and 16 weeks ]
  • Sleep Impairment [ Time Frame: Change from baseline at 8 and 16 weeks ]

Central Contacts and Locations

Central contacts

Alana Biggers, MD, MPH

312-413-1793abigger2@uic.edu

Alyssa Lawrence

amlawre2@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 606012

Contacts

Arthi Dutta

312-413-5372myessence@uic.edu

Principal Investigator:

Alana Biggers, MD, MPH

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Mar 5, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-21. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-03-05.