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

Not Applicable

Recruiting

• Conditions: Hypertension; Type2diabetes; Metabolic Syndrome; Obesity

• Registration Number: NCT06460272
• Lead Sponsor: Amanda Shallcross

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-6-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Self-identification as Black or African American<br><br> 2. Ability to speak and read English<br><br> 3. Age = 18 years old<br><br> 4. Diagnosis of any of the following: a) Hypertension (>130/80), and ever treated for<br> hypertension; b) Type 2 Diabetes Mellitus (HgbA1c = 8%); c) Metabolic Syndrome; d)<br> Obesity (BMI = 30)<br><br> 5. Access to a web-enabled device (phone, tablet, computer)<br><br> 6. Received care at Cleveland Clinic South Pointe Hospital within the past 6 months<br><br>Exclusion Criteria:<br><br> 1. Pre-hypertension<br><br> 2. Stage C and D heart failure<br><br> 3. Advanced valvular heart disease<br><br> 4. Advanced heart failure class D defined as heart failure symptoms impairing daily<br> quality of life and/or resulting in recurrent hospitalizations (>1) per previous 12<br> months<br><br> 5. Insulin requiring type II diabetes mellitus<br><br> 6. Type I diabetes mellitus<br><br> 7. Advanced chronic kidney disease (= Stage 4)<br><br> 8. Severe obesity (Grade III or above) as defined by BMI > 40 kg/m2<br><br> 9. Patients who are in another study or nutritional support program supplying meals<br><br> 10. Advanced co-morbidity with diminished life expectancy < 2 years<br><br> 11. Co-morbidity requiring immunosuppressive, immunotherapy, chemotherapy, chronic<br> antibiotic therapy<br><br> 12. Inability to participate in the demands and requirements of the trial<br><br> 13. Significant cognitive impairment

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recruitment Rate;Retention Rate;SMA Attendance;MTMs Consumed;Satisfaction of the Intervention

Secondary Outcome Measures

Name	Time	Method
Eating Behavior;Body Weight;Waist/Hip Circumference;Systolic and Diastolic Blood Pressure (mmHg);Hemoglobin A1c (HbA1c, mmol/mol);Trimethylamine N-oxide (TMAO, uM);Uric Acid (mg/dL);Vitamin D 25 Hydroxy (ng/mL);High Sensitivity C-Reactive Protein (hsCRP, mg/dL)