Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support (NOURISH HEARTS)

December 1, 2025 updated by: Amanda Shallcross

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will be randomized into one of the three arms within the study:

Medically Tailored Meals (MTMs):

Collaborative agreements are in place with Performance Kitchen to prepare 2 meals/day for 7 days/week for 10 weeks at a discount for all participants (n =75) for this trial. Meals will be prepared based on evidence-based nutritional recommendations for the Mediterranean diet and that align with 2021 American Heart Association Dietary Guidance. Individuals randomized to MTMs will receive electronic educational materials from the MTM + SMA group after the completion of the post-intervention study assessment.

Medically Tailored Meals + Shared Medical Appointments (MTMs + SMAs):

Identical MTMs that are provided in the MTM only group will also be provided in the MTM + SMA group. The SMA will be delivered weekly for 10 weeks and will be modeled after the investigator's pilot study. This includes practice with behavior change principles (i.e., selection of healthy food options). The provider, dietician, chef, and health coach will be members of the Black community to ensure racial concordance between educators and participants, a critical feature that improves communication, trust, and health outcomes in behavioral health interventions. The provider, dietician, and health coach are professionals currently employed within the Department of Wellness and Preventive Medicine. Fidelity will be ensured by using a session fidelity checklist that will be completed by each facilitator. To maximize retention, during consent via (telephone or in-person the study coordinator will establish rapport and set study expectations, including what SMAs entail and the time commitment for the session to minimize attrition. SMA visit reminder emails will be sent to participants through their EHR portal and/or via email.

Medically Tailored Meals - Later (MTM-Later):

The inclusion of a MTM-Later arm will provide a rigorous test of outcomes and is necessary given limited data about MTM implementation, engagement, and clinical outcomes in Black, underserved communities. MTM-Later participants will receive MTMs (same quantity and frequency) as the two other groups after the completion of the post-intervention study assessment. To avoid differential drop-out and incomplete assessments in the MTM-Later group, this group will be offered culinary tools at the start of the intervention to build trust and confidence that they will indeed receive the meals and educational materials at the end of the study assessment period. This group will act as the Waitlist Control group.

All groups will receive a set of surveys to be given at baseline and weeks 5 and 10 for exploratory outcomes. All groups will also have labs drawn at baseline and week 10 to measure secondary outcomes such as change in HbA1c.

4 focus groups will also be conducted (2 groups from each treatment arm) to understand barriers and facilitators to engaging in each of the active treatments.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 or Main Campus 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medically Tailored Meals (MTMs)
Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks. Individuals randomized to MTMs will receive electronic educational materials from the MTM + SMA group after the completion of the post-intervention study assessment.
Other: Medically Tailored Meals
Meals culturally tailored to provide essential nutrition
Other: Medically Tailored Meals - Later (MTM-Later)
Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and educational materials (e.g., relevant handouts from the SMA) after the completion of the post intervention study assessment. This group will act as our Waitlist Control group.
Other: Medically Tailored Meals
Meals culturally tailored to provide essential nutrition
Experimental: Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs)
Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and SMA weekly for 10 weeks.
Other: Medically Tailored Meals
Meals culturally tailored to provide essential nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Baseline through Week 10
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
Time Frame: Baseline through Week 10
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
Time Frame: Baseline through Week 10
Engagement will be assessed by Shared Medical Appointment (SMA) session attendance over the 10 week period.
Baseline through Week 10
MTMs Consumed
Time Frame: Baseline through Week 10
Engagement will be assessed by proportion of Medically Tailored Meals (MTMs) consumed.
Baseline through Week 10
Satisfaction of the Intervention
Time Frame: Baseline through Week 10
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

Outcome Measure
Measure Description
Time Frame
Eating Behavior
Time Frame: Baseline and Week 10
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
Time Frame: Baseline and Week 10
Body weight will be measured in pounds.
Baseline and Week 10
Waist/Hip Circumference
Time Frame: Baseline and Week 10
Waist/Hip circumference will be expressed as a ratio.
Baseline and Week 10
Systolic and Diastolic Blood Pressure (mmHg)
Time Frame: Baseline and Week 10
Systolic and diastolic blood pressure will be measured and expressed as mmHg.
Baseline and Week 10
Hemoglobin A1c (HbA1c, mmol/mol)
Time Frame: Baseline and Week 10
Hemoglobin A1c will be evaluated through peripheral blood draw to assess diabetes control.
Baseline and Week 10
Trimethylamine N-oxide (TMAO, uM)
Time Frame: Baseline and Week 10
Trimethylamine N-oxide will be evaluated through peripheral blood draw to assess cardiovascular disease risk.
Baseline and Week 10
Uric Acid (mg/dL)
Time Frame: Baseline and Week 10
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)
Time Frame: Baseline and Week 10
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)
Time Frame: Baseline and Week 10
High Sensitivity C-Reactive Protein will be evaluated through peripheral blood draw to assess inflammation.
Baseline and Week 10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative characterization of participants' lived experiences and engagement
Time Frame: Week 10
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amanda Shallcross

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Amanda Shallcross, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2024

Primary Completion (Actual)

February 27, 2025

Study Completion (Actual)

March 6, 2025

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-472

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository.

IPD Sharing Time Frame

No later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever come first.

IPD Sharing Access Criteria

Individual participant data will become available at the conclusion of the study upon request by qualified individuals in the research community.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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