Healthy Eating and Support for Heart Health
NOURISH HEARTS: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
This study is testing whether providing specially prepared meals alone or with group medical support can help people with high blood pressure, diabetes, obesity, and metabolic syndrome feel healthier over 10 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06460272 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of Medically Tailored Meals (MTM) alone versus MTM combined with Shared Medical Appointments (SMA) in improving health outcomes for individuals with hypertension, type 2 diabetes, obesity, and metabolic syndrome. Participants will receive culturally tailored meals and educational support over a 10-week period. The study aims to assess recruitment, retention, engagement, and satisfaction among participants from a predominantly Black community. The trial will involve 75 participants recruited from Cleveland Clinic's South Pointe Hospital.
Who should consider this trial
Good fit: Ideal candidates are Black or African American adults aged 18 and older with hypertension, type 2 diabetes, obesity, or metabolic syndrome.
Not a fit: Patients with pre-hypertension, advanced heart failure, or those requiring insulin for diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve dietary habits and health outcomes for patients with chronic conditions.
How similar studies have performed: Other studies have shown success with culturally tailored dietary interventions, suggesting potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Self-identification as Black or African American 2. Ability to speak and read English 3. Age ≥ 18 years old 4. 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) 5. Access to a web-enabled device (phone, tablet, computer) 6. Received care at Cleveland Clinic South Pointe Hospital within the past 6 months Exclusion Criteria: 1. Pre-hypertension 2. Stage C and D heart failure 3. Advanced valvular heart disease 4. 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 5. Insulin requiring type II diabetes mellitus 6. Type I diabetes mellitus 7. Advanced chronic kidney disease (≥ Stage 4) 8. Severe obesity (Grade III or above) as defined by BMI \> 40 kg/m2 9. Patients who are in another study or nutritional support program supplying meals 10. Advanced co-morbidity with diminished life expectancy \< 2 years 11. Co-morbidity requiring immunosuppressive, immunotherapy, chemotherapy, chronic antibiotic therapy 12. Inability to participate in the demands and requirements of the trial 13. Significant cognitive impairment
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Amanda Shallcross — The Cleveland Clinic
- Study coordinator: Narissa McCarty
- Email: mccartn3@ccf.org
- Phone: 2167801931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.