DOI: 10.5061/dryad.280gb5n3c
title: Data from: NOURISH HEARTS: Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support

description: 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) &gt;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).
description: # Data from: NOURISH HEARTS: Nutrition Outreach and Understanding:
 Research In Serving Hearts Through Healthy Eating And Tailored Support
 Dataset DOI:
 [10.5061/dryad.280gb5n3c](https://doi.org/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 (&gt; 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 (&gt; 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 &gt; 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.