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HypertensionNOURISH HEARTSNCT06460272

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

A study testing Medically Tailored Meals in people with Hypertension and Type2diabetes, run by Amanda Shallcross at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Type2diabetes, Metabolic Syndrome
What is being tested?
Medically Tailored Meals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
30 Jul 2024to 6 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-identification as Black or African American
  • Ability to speak and read English
  • Age ≥ 18 years old
  • 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)
  • Access to a web-enabled device (phone, tablet, computer)
  • Received care at Cleveland Clinic South Pointe Hospital or Main Campus within the past 6 months

Who cannot join

  • Stage C and D heart failure
  • Advanced valvular heart disease
  • 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
  • Insulin requiring type II diabetes mellitus
  • Type I diabetes mellitus
  • Advanced chronic kidney disease (≥ Stage 4)
Show all 12Show fewer
  • BMI > 45 kg/m2
  • Patients who are in another study or nutritional support program supplying meals
  • Patients who are receiving a medically prescribed diet with a specific nutritional profile
  • Receiving active cancer treatment, not including endocrine therapy
  • Inability to participate in the demands and requirements of the trial
  • Significant cognitive impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Medically Tailored Meals
Keywords
Hypertension, Type2diabetes, Metabolic Syndrome, Obesity
Medical subject headings
Hypertension, Metabolic Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medically Tailored MealsOther

    Meals culturally tailored to provide essential nutrition

Study groups in NCT06460272
Study groupRoleWhat they receive
Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs)ExperimentalParticipants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and SMA weekly for 10 weeks.
Receives: Other: Medically Tailored Meals
Medically Tailored Meals (MTMs)Active comparatorParticipants 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.
Receives: Other: Medically Tailored Meals
Medically Tailored Meals - Later (MTM-Later)OtherParticipants 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.
Receives: Other: Medically Tailored Meals

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

    Recruitment is a measure of treatment implementation. Recruitment rate will be measured by # of participants enrolled in study/# passed eligibility screening.

    Measured: Baseline through Week 10

  2. 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.

    Measured: Baseline through Week 10

  3. SMA Attendance

    Engagement will be assessed by Shared Medical Appointment (SMA) session attendance over the 10 week period.

    Measured: Baseline through Week 10

  4. MTMs Consumed

    Engagement will be assessed by proportion of Medically Tailored Meals (MTMs) consumed.

    Measured: Baseline through Week 10

  5. 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)

    Measured: Baseline through Week 10

Secondary outcomes (9)

  1. Eating Behavior

    Changes in eating behavior will be measured using the Mini-EAT (Eating Assessment Tool) and Fast Food/Restaurant Frequency Questionnaires.

    Measured: Baseline and Week 10

  2. Body Weight

    Body weight will be measured in pounds.

    Measured: Baseline and Week 10

  3. Waist/Hip Circumference

    Waist/Hip circumference will be expressed as a ratio.

    Measured: Baseline and Week 10

  4. Systolic and Diastolic Blood Pressure (mmHg)

    Systolic and diastolic blood pressure will be measured and expressed as mmHg.

    Measured: Baseline and Week 10

  5. Hemoglobin A1c (HbA1c, mmol/mol)

    Hemoglobin A1c will be evaluated through peripheral blood draw to assess diabetes control.

    Measured: Baseline and Week 10

  6. Trimethylamine N-oxide (TMAO, uM)

    Trimethylamine N-oxide will be evaluated through peripheral blood draw to assess cardiovascular disease risk.

    Measured: Baseline and Week 10

  7. Uric Acid (mg/dL)

    Uric Acid will be evaluated through peripheral blood draw to assess cardiovascular disease and diabetes risk.

    Measured: Baseline and Week 10

  8. Vitamin D 25 Hydroxy (ng/mL)

    Vitamin D 25 Hydroxy will be evaluated through peripheral blood draw to asses for Vitamin D deficiency.

    Measured: Baseline and Week 10

  9. High Sensitivity C-Reactive Protein (hsCRP, mg/dL)

    High Sensitivity C-Reactive Protein will be evaluated through peripheral blood draw to assess inflammation.

    Measured: Baseline and Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study start30 Jul 2024
  3. Primary completion27 Feb 2025
  4. Study completion6 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a human-centered three-arm design implementation trial to compare MTM only vs. MTM + SMA (weekly culinary and nutrition education and practice for 10 weeks) vs. a wait-list control group (MTM-Later). Meals will be provided at a frequency of 14 meals/week for 10 weeks. All intervention components will be designed and intended to be culturally congruent. Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). This study aims to distinguish an effective treatment (e.g., MTM only or MTM + SMAs) from a less effective or ineffective treatment. For this study, the investigators propose a three-arm (1:1:1) parallel-group randomized controlled trial (n = 75) powered to detect threshold levels of implementation and engagement. Intervention arms include, 1) MTM (only), 2) MTM +SMA, and a 3) Wait-list Control.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06460272
Sponsor's protocol ID
24-472
Acronym
NOURISH HEARTS
Status last verified
Dec 2025
First submitted
4 Jun 2024
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository.

Publications

  • Satia JA. Diet-related disparities: understanding the problem and accelerating solutions. J Am Diet Assoc. 2009 Apr;109(4):610-5. doi: 10.1016/j.jada.2008.12.019. No abstract available.

    PubMed 19328255

  • Eisenhauer E. In poor health: Supermarket redlining and urban nutrition. GeoJournal. 2001;53(2):125-133. doi:10.1023/A:1015772503007

  • Black/African American Health-Office of Minority Health. Accessed October 24, 2023. https://minorityhealth.hhs.gov/blackafrican-american-health

  • FastStats- Leading Causes of Death. Centers for Disease Control and Prevention. Published January 18, 2023. Accessed October 24, 2023. https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm

  • Benjamins MR, Silva A, Saiyed NS, De Maio FG. Comparison of All-Cause Mortality Rates and Inequities Between Black and White Populations Across the 30 Most Populous US Cities. JAMA Netw Open. 2021 Jan 4;4(1):e2032086. doi: 10.1001/jamanetworkopen.2020.32086.

    PubMed 33471116

  • Belak L, Owens C, Smith M, Calloway E, Samnadda L, Egwuogu H, Schmidt S. The impact of medically tailored meals and nutrition therapy on biometric and dietary outcomes among food-insecure patients with congestive heart failure: a matched cohort study. BMC Nutr. 2022 Oct 3;8(1):108. doi: 10.1186/s40795-022-00602-y.

    PubMed 36192812

  • Berkowitz SA, Delahanty LM, Terranova J, Steiner B, Ruazol MP, Singh R, Shahid NN, Wexler DJ. Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over Trial. J Gen Intern Med. 2019 Mar;34(3):396-404. doi: 10.1007/s11606-018-4716-z. Epub 2018 Nov 12.

    PubMed 30421335

  • Hager K, Cudhea FP, Wong JB, Berkowitz SA, Downer S, Lauren BN, Mozaffarian D. Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. JAMA Netw Open. 2022 Oct 3;5(10):e2236898. doi: 10.1001/jamanetworkopen.2022.36898.

    PubMed 36251292

  • Berkowitz SA, Shahid NN, Terranova J, Steiner B, Ruazol MP, Singh R, Delahanty LM, Wexler DJ. "I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. BMC Endocr Disord. 2020 Jan 20;20(1):10. doi: 10.1186/s12902-020-0491-z.

    PubMed 31959176

  • Winham DM. Culturally tailored foods and CVD prevention. Am J Lifestyle Med. 2009;3(1):64S-68S. doi: 10.1177/1559827609335552.

    PubMed 20046905

  • Bharmal N, Beidelschies M, Alejandro-Rodriguez M, Alejandro K, Guo N, Jones T, Bradley E. A nutrition and lifestyle-focused shared medical appointment in a resource-challenged community setting: a mixed-methods study. BMC Public Health. 2022 Mar 7;22(1):447. doi: 10.1186/s12889-022-12833-6.

    PubMed 35255887

  • Gardiner P, McGonigal L, Villa A, Kovell LC, Rohela P, Cauley A, Rinker D, Olendzki B. Our Whole Lives for Hypertension and Cardiac Risk Factors-Combining a Teaching Kitchen Group Visit With a Web-Based Platform: Feasibility Trial. JMIR Form Res. 2022 May 16;6(5):e29227. doi: 10.2196/29227.

    PubMed 35576575

  • Rohela P, Olendzki B, McGonigal LJ, Villa A, Gardiner P. A Teaching Kitchen Medical Groups Visit with an eHealth Platform for Hypertension and Cardiac Risk Factors: A Qualitative Feasibility Study. J Altern Complement Med. 2021 Nov;27(11):974-983. doi: 10.1089/acm.2021.0148. Epub 2021 Aug 5.

    PubMed 34357790

  • Lichtenstein AH, Appel LJ, Vadiveloo M, Hu FB, Kris-Etherton PM, Rebholz CM, Sacks FM, Thorndike AN, Van Horn L, Wylie-Rosett J. 2021 Dietary Guidance to Improve Cardiovascular Health: A Scientific Statement From the American Heart Association. Circulation. 2021 Dec 7;144(23):e472-e487. doi: 10.1161/CIR.0000000000001031. Epub 2021 Nov 2.

    PubMed 34724806

  • Moore C, Coates E, Watson A, de Heer R, McLeod A, Prudhomme A. "It's Important to Work with People that Look Like Me": Black Patients' Preferences for Patient-Provider Race Concordance. J Racial Ethn Health Disparities. 2023 Oct;10(5):2552-2564. doi: 10.1007/s40615-022-01435-y. Epub 2022 Nov 7.

    PubMed 36344747

Questions about this trial

What is this clinical trial studying?

A study testing Medically Tailored Meals in people with Hypertension and Type2diabetes, run by Amanda Shallcross at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Baseline through Week 10). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06460272, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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