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Behavioral Intervention

Mindfulness Meditation for Type 2 Diabetes (E-RCT Trial)

N/A

Recruiting

Led By Alana Biggers

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of type 2 diabetes

Age 21-75

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 8 weeks

Awards & highlights

E-RCT Trial Summary

This trial will study whether a mindfulness meditation program can help African-American adults with type 2 diabetes improve their sleep and reduce stress, which may in turn reduce their risk of cardiovascular disease.

Who is the study for?

This trial is for African-American adults aged 21-75 with type 2 diabetes living in the greater Chicagoland area. Participants must have a mobile device with internet and be able to text. They can't join if they already practice mindfulness, have severe sleep disorders, major cognitive or psychiatric issues, substance abuse problems, or untreated obstructive sleep apnea.Check my eligibility

What is being tested?

The study tests a mindfulness meditation program aimed at improving sleep and reducing stress in African-Americans with type 2 diabetes. The goal is to see if this program can lower their risk of cardiovascular disease.See study design

What are the potential side effects?

Mindfulness meditation is generally considered safe but may cause temporary discomfort like increased anxiety or emotional distress as participants become more aware of their thoughts and feelings.

E-RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with type 2 diabetes.

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I am between 21 and 75 years old.

E-RCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 8 and 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 8 and 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 8 and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perceived Stress

Sleep Disturbances

Sleep Impairment

+1 more

Secondary outcome measures

Cardiovascular Risk

Hemoglobin A1c

Inflammatory Markers

E-RCT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mindfulness Meditation ClassesExperimental Treatment1 Intervention

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 II: Usual CareActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

3,837 Previous Clinical Trials

47,851,527 Total Patients Enrolled

University of Illinois at ChicagoLead Sponsor

609 Previous Clinical Trials

1,559,209 Total Patients Enrolled

Alana BiggersPrincipal InvestigatorUniversity of Illinois at Chicago

Media Library

Mindfulness Meditation (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05208164 — N/A

Type 2 Diabetes Research Study Groups: Usual Care, Mindfulness Meditation Classes

Type 2 Diabetes Clinical Trial 2023: Mindfulness Meditation Highlights & Side Effects. Trial Name: NCT05208164 — N/A

Mindfulness Meditation (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05208164 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are being monitored for this medical experiment?

"Affirmative, according to clinicaltrials.gov this medical investigation is presently recruiting subjects. It was first published on May 15th 2022 and the most recent update was recorded on May 24th 2022. The trial seeks 100 participants across a single site."

Answered by AI

Does this clinical trial include minors as potential participants?

"This research project is looking to recruit participants aged 21 and above, up until the age of 75."

Answered by AI

Are there still vacancies in this experiment for participants?

"Affirmative. Data on clinicaltrials.gov indicates that this research trial, which was first announced on May 15th 2022, is actively recruiting volunteers now. The project seeks to enrol approximately 100 participants over 1 site."

Answered by AI

Am I eligible to partake in this clinical trial?

"This clinical trial is sourcing 100 individuals aged 21 to 75 who have been diagnosed with type 2 diabetes mellitus. Furthermore, participants must self-identify as African American or Black, reside in the greater Chicagoland area, possess an unlimited text messaging plan on their mobile phone, be available for mindfulness sessions either virtually or face-to-face and own a mobile device such as a smartphone, tablet or computer that has access to internet if remote online delivery is preferred."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Alana Biggers 2021. "My ESSENCE - A Research Study on Mindfulness for African-Americans With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05208164.