Clinical trial NCT05208164: My ESSENCE - A Research Study on Mindfulness for African-Americans With Type 2 Diabetes
Official title: My ESSENCE - Mindfulness to Reduce Stress, Improve SIeep, and Reduce Cardiovascular Risk in African-Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Sleep
Stress
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Sleep Quality
timeFrame: Change from baseline at 8 and 16 weeks.
measure: Perceived Stress
timeFrame: Change from baseline at 8 and 16 weeks.
measure: Sleep Disturbances
timeFrame: Change from baseline at 8 and 16 weeks
measure: Sleep Impairment
timeFrame: Change from baseline at 8 and 16 weeks
Secondary outcomes:
measure: Cardiovascular Risk
timeFrame: Change from baseline at 8 weeks
measure: Hemoglobin A1c
timeFrame: Change from baseline at 8 weeks.
measure: Inflammatory Markers
timeFrame: Change from baseline at 8 and 16 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Alana Biggers
role: PRINCIPAL_INVESTIGATOR
References: