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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

Must not have

Severe insomnia, narcolepsy, or REM sleep related disorder

Untreated obstructive sleep apnea (OSA)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 8 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe insomnia, narcolepsy, or a REM sleep disorder.

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I have sleep apnea that has not been treated.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Perceived Stress

Sleep Disturbances

Sleep Impairment

+1 more

Secondary study objectives

Cardiovascular Risk

Hemoglobin A1c

Inflammatory Markers

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met