NCT06460272Completed
Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
NOURISH HEARTS: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
Source: ClinicalTrials.gov · Last updated 5 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 4 Jun 2024
- Start date
- 30 Jul 2024
- Primary completion date
- 27 Feb 2025
- Lead sponsor
- Amanda Shallcross
- Diseases
- Obesity, High blood pressure
- NCT number
- NCT06460272
What you commit to
- Study type: Interventional
- Participants enrolled: 75
- From 30 Jul 2024 to the primary completion date, 27 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Patients who are receiving a medically prescribed diet with a specific nutritional profile
- Receiving active cancer treatment, not including endocrine therapy
Other illness
- Stage C and D heart failure
- Advanced valvular heart disease
- Insulin requiring type II diabetes mellitus
- Type I diabetes mellitus
- Advanced chronic kidney disease (≥ Stage 4)
- Significant cognitive impairment
Other
- BMI \> 45 kg/m2
- Patients who are in another study or nutritional support program supplying meals
- Inability to participate in the demands and requirements of the trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.