Data from: NOURISH HEARTS: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
Data files
Jan 23, 2026 version files 150.14 KB
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NOURISH_HEARTS_Data_Dictionary.xlsx
33.28 KB
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NOURISH_HEARTS_Deidentified_Data.xlsx
110.34 KB
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README.md
6.53 KB
Abstract
Black communities in the U.S. are among the most disenfranchised in terms of equal access to healthy food and nutrition education. As a result, Black Americans are more likely to consume low-quality foods with poor nutritional value that are associated with cardiometabolic disease. Medically tailored meals (MTM) are a promising food-is-medicine intervention to address nutrition inequities, but they lack the ability to provide nutrition education and behavior change skills. Shared medical appointments (SMA) can offer the education and training needed to achieve sustainable healthy eating behaviors. This study examined the feasibility, acceptability, and preliminary biopsychosocial effects of MTM and MTM+SMA in a Black community with cardiometabolic disease. We hypothesized that 1) the study is feasible (≥ 40 % recruitment rate, ≥ 70 % retention rate in each arm), 2) the intervention is feasible (≥75 % SMA attendance, ≥ 60 % meals consumed), and 3) the intervention is acceptable (net promoter score (NPS) >9 in the MTM and MTM+SMA arms). We conducted a three-arm pilot randomized controlled trial. Study arms included: (1) MTM (2 meals daily for 10 weeks), (2) MTM+SMA (same MTMs plus 10 weekly 1–2-hour group medical visits), and (3) MTM-Later (waitlist control- same MTMs provided after the intervention period). Participants were adults (≥ 18 years old) who self-identify as Black/African American and have cardiometabolic disease. A total of 67 participants were randomized to the three study arms; MTM (n = 24), MTM+SMA (n = 21) and MTM-Later (n = 22).
Dataset DOI: 10.5061/dryad.280gb5n3c
Description of the data and file structure
Study Population:
Inclusion Criteria
1. Self-identification as African ancestry
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 one of two hospitals in Ohio within the past 6 months
Exclusion Criteria
1. Stage C and D heart failure
2. Advanced valvular heart disease
3. 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
4. Insulin requiring type II diabetes mellitus
5. Type I diabetes mellitus
6. Advanced chronic kidney disease (≥ Stage 4)
7. BMI > 45 kg/m2
8. Patients who are in another study or nutritional support program supplying meals
9. Patients who are receiving a medically prescribed diet with a specific nutritional profile
10. Receiving active cancer treatment, not including endocrine therapy
11. Inability to participate in the demands and requirements of the trial
12. Significant cognitive impairment
Interventions
Group 1: MTM: Participants assigned to the Medically Tailored Meals (MTM) group received two MTMs per day, seven days per week, for a total duration of 10 weeks. All meals were designed to align with evidence-based nutritional recommendations for the Mediterranean diet, consistent with the American Heart Association’s (AHA) dietary guidance. Meals were prepared and delivered frozen weekly to participants’ homes through a partnership with Performance Kitchen (PK). PK follows a nutrition-forward approach that can be replicated by adhering to its key standards: meals contain ≤ 590 mg sodium, ≤ 3 g added sugar, and 1–4 servings of vegetables. They use extra virgin olive oil, no artificial colors or flavors, and ensure every meal is a good or excellent source of dietary fiber. Proteins are responsibly sourced, antibiotic-free chicken and pork, sustainable fish, lean beef, and whole-plant proteins like beans, nuts, seeds, and lentils. Participants were able to select their preferred meals from a menu of options that all adhered to the AHA’s dietary guidance. Participants also had the option to access the South Pointe Hospital fresh food pantry if they qualified to access the pantry and chose to do so. In addition, culinary tools such as knives, cutting boards, measuring cups, mixing bowls, box graters, and cooking utensils were provided at the baseline visit to support future meal preparation. Electronic educational materials were made available to participants after the post-intervention assessment.
Group 2: MTM + SMA: Participants assigned to the MTM + SMA (Shared Medical Appointment) group received the same medically tailored meals as the MTM group, consisting of two meals per day, seven days per week, for 10 weeks, based on the AHA’s dietary guidance. In addition to the meals, participants attended 10 weekly one to two-hour SMAs that coincided with the MTM deliveries. These SMAs were culturally tailored and covered nutrition education, stress management, cooking demonstrations, and behavior change strategies. To ensure fidelity, each session followed a structured checklist.
Group 3: MTM-Later (Waitlist Control): Participants assigned to the MTM-Later group served as a waitlist control to provide a rigorous comparison for evaluating implementation, engagement, and preliminary efficacy outcomes. During the initial 10-week intervention period, these participants did not receive MTMs or SMAs but were assured that they would receive the same quantity and frequency of MTMs after completing the post-intervention assessment. This approach was designed to address the limited existing data on the implementation and impact of MTMs in underserved Black communities and to minimize differential drop-out by reinforcing trust and transparency. To further build confidence that they would receive the promised intervention, participants in all three groups, including MTM-Later, were provided culinary tools at baseline and were offered information about South Pointe Hospital’s fresh food pantry, which they could choose to access during the study if they qualified. By using a waitlist control design, the study balanced scientific rigor with a commitment to equitable access to intervention benefits for all participants.
Data Collection
Questionnaires: Participants of the NOURISH Hearts trial received questionnaires at baseline, week 5 (midpoint), post-intervention, and weekly during the intervention (adherence tracking). Questionnaires were sent via email and administered online through REDCap.
Clinical Measures: Participants came to Cleveland Clinic's South Pointe Hospital at baseline and post-intervention to have labs drawn, and measure height, weight, and waist-hip ratio. Blood pressure was collected through EHR search at time of baseline and post-intervention (most recent in-clinic measure and date of measure were recorded).
Files and variables
File Names:
- NOURISH_HEARTS_Data_Dictionary.xlsx
- Data dictionary
- Note: some variable keys were removed to retain the anonymity of study participants. Additionally, some variables were adjusted to be differences over time to further mask the participants' actual medical information.
- NOURISH_HEARTS_Deidentified_Data.xlsx
- Study data
- Missing data indicated with "null"
- For surveys: participants were given the option to not answer any question they were not comfortable answering.
- For clinical measures: data missing due to participant not showing up to visit.
- Non-applicable fields indicated with "n/a"
- Height measured in centimeters, weight measured in kilograms, blood pressure measured in mmHg
Human subjects data
We received explicit consent from participants to publish their de-identified data in the public domain. The data was reviewed by the study team and all identifiable information was removed prior to publication.
