Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support

Launched by AMANDA SHALLCROSS · Jun 10, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Nutrition Outreach and Understanding," is exploring how specific meal plans and group support can help people with high blood pressure, type 2 diabetes, obesity, and metabolic syndrome. Participants will be randomly assigned to one of three groups: one group will receive medically tailored meals delivered to their home for 10 weeks, another group will receive the meals along with weekly group appointments to discuss health topics, and the last group will wait to receive meals later. The study aims to determine how well these programs work and how satisfied participants are with the support they receive.

To join the trial, participants must be Black or African American adults aged 18 or older, have certain health conditions like high blood pressure or diabetes, and have received care at the Cleveland Clinic South Pointe Hospital in the past six months. Participants should also have access to a device that connects to the internet. This study is particularly focused on the local community in Warrensville Heights, which has a high rate of heart disease. If eligible, participants can expect to receive tailored meals and support to help improve their health over the 10 weeks.

Gender

ALL

Eligibility 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