Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
NCT Number: NCT06460272
Acronym: NOURISH HEARTS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension|Type2diabetes|Metabolic Syndrome|Obesity
Interventions: OTHER: Medically Tailored Meals
Sponsor: Amanda Shallcross
Collaborators: American Heart Association
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-30
Completion Date: 2025-12-19
Locations: Cleveland Clinic, Cleveland, Ohio, 44106, United States

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.

Primary Outcome Measures: Recruitment Rate, Recruitment is a measure of treatment implementation. Recruitment rate will be measured by # of participants enrolled in study/# passed eligibility screening., Baseline through Week 10|Retention Rate, Retention is a measure of treatment implementation. Retention rate will be measured by # of completed assessments at week 10/# randomized to treatment arm., Baseline through Week 10|SMA Attendance, Engagement will be assessed by Shared Medical Appointment (SMA) session attendance over the 10 week period., Baseline through Week 10|MTMs Consumed, Engagement will be assessed by proportion of Medically Tailored Meals (MTMs) consumed., Baseline through Week 10|Satisfaction of the Intervention, Satisfaction of MTM vs. MTM + SMA will be assessed using the Net Promoter Score (scale of 0 to 10; 9-10 being promoters, 7-8 being passives, and 0-6 being detractors), Baseline through Week 10
Secondary Outcome Measures: Eating Behavior, Changes in eating behavior will be measured using the Mini-EAT (Eating Assessment Tool) and Fast Food/Restaurant Frequency Questionnaires., Baseline and Week 10|Body Weight, Body weight will be measured in pounds., Baseline and Week 10|Waist/Hip Circumference, Waist/Hip circumference will be expressed as a ratio., Baseline and Week 10|Systolic and Diastolic Blood Pressure (mmHg), Systolic and diastolic blood pressure will be measured and expressed as mmHg., Baseline and Week 10|Hemoglobin A1c (HbA1c, mmol/mol), Hemoglobin A1c will be evaluated through peripheral blood draw to assess diabetes control., Baseline and Week 10|Trimethylamine N-oxide (TMAO, uM), Trimethylamine N-oxide will be evaluated through peripheral blood draw to assess cardiovascular disease risk., Baseline and Week 10|Uric Acid (mg/dL), Uric Acid will be evaluated through peripheral blood draw to assess cardiovascular disease and diabetes risk., Baseline and Week 10|Vitamin D 25 Hydroxy (ng/mL), Vitamin D 25 Hydroxy will be evaluated through peripheral blood draw to asses for Vitamin D deficiency., Baseline and Week 10|High Sensitivity C-Reactive Protein (hsCRP, mg/dL), High Sensitivity C-Reactive Protein will be evaluated through peripheral blood draw to assess inflammation., Baseline and Week 10
Other Outcome Measures: Qualitative characterization of participants' lived experiences and engagement, 4 focus groups (n=5 in each group, 2 groups from each treatment arm - MTM and MTM + SMA) will be conducted to understand barriers and facilitators to engaging in each of the active treatments., Week 10