Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailo… (NCT06460272) | Clinical Trial Compass
CompletedNot Applicable
Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
United States75 participantsStarted 2024-07-30
Plain-language summary
This study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Self-identification as Black or African American
✓. Ability to speak and read English
✓. Age ≥ 18 years old
✓. Diagnosis of any of the following: a) Hypertension (\>130/80), and ever treated for hypertension; b) Type 2 Diabetes Mellitus (HgbA1c ≥ 8%); c) Metabolic Syndrome; d) Obesity (BMI ≥ 30)
✓. Access to a web-enabled device (phone, tablet, computer)
✓. Received care at Cleveland Clinic South Pointe Hospital or Main Campus within the past 6 months
Exclusion criteria
✕. Stage C and D heart failure
✕. Advanced valvular heart disease
✕. Advanced heart failure class D defined as heart failure symptoms impairing daily quality of life and/or resulting in recurrent hospitalizations (\>1) per previous 12 months