Medically Tailored Meals for Metabolic Health

(NOURISH HEARTS Trial)

Overseen By Narissa McCarty

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Amanda Shallcross

Disqualifiers: Heart failure, Type I diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Medically Tailored Meals can improve health in individuals with conditions like high blood pressure, type 2 diabetes, obesity, or metabolic syndrome. Participants will either receive meals alone, meals plus group medical visits, or be on a waitlist to receive meals later, to determine which approach is most effective. The trial seeks Black or African American individuals who have received treatment at Cleveland Clinic's South Pointe Hospital, speak English, and have access to a web-enabled device.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance health outcomes for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Medically Tailored Meals (MTMs) are safe for people. Studies have found that MTMs help over 90% of participants adhere to their meal plans. This adherence is crucial because a healthy diet can help manage chronic illnesses like diabetes and heart disease.

In addition to being safe, MTMs are associated with positive health benefits. For example, one study found that MTMs reduced the risk of malnutrition and the need for healthcare services. Another study demonstrated that MTMs improved health for individuals with serious illnesses and special nutritional needs.

No specific data indicate major safety issues or negative effects related to MTMs in the sources provided. Overall, MTMs appear well-tolerated and safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using medically tailored meals (MTMs) for metabolic health because they offer a personalized dietary approach, unlike standard medications or generic diet plans. Unlike typical treatments that might focus on medication or general nutritional advice, MTMs provide specific meals designed to meet individual health needs, potentially leading to better metabolic outcomes. Additionally, the combination of MTMs with shared medical appointments (SMAs) offers an innovative way to support patients, blending nutritional support with regular medical guidance, which could enhance adherence and effectiveness. This approach aims to improve metabolic health more holistically by focusing on tailored nutrition and consistent medical interaction.

What evidence suggests that this trial's treatments could be effective for metabolic health?

Research has shown that Medically Tailored Meals (MTMs) can significantly improve health for individuals with serious illnesses. Studies have found that over 90% of participants in MTM programs adhere to their recommended diets, aiding in the management of chronic diseases like high blood pressure and type 2 diabetes. Additionally, MTMs are associated with fewer hospital visits within 90 days for those at risk of poor nutrition. In this trial, participants will be assigned to different groups: MTMs alone, MTMs combined with Shared Medical Appointments (SMAs), or a waitlist control group receiving MTMs later. These meals are specifically designed to meet the medical and nutritional needs of patients, helping to manage and potentially improve conditions related to metabolic health. ^{1 3 4 6 7}

Who Is on the Research Team?

Amanda Shallcross

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for Black or African American adults over 18 with hypertension, type 2 diabetes, metabolic syndrome, or obesity. They must have been treated at Cleveland Clinic South Pointe Hospital recently and be able to use a web-enabled device in English.

Inclusion Criteria

I identify as Black or African American.

I have been treated at Cleveland Clinic South Pointe Hospital in the last 6 months.

I can speak and read English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Medically Tailored Meals (MTMs) or MTMs + Shared Medical Appointments (SMAs) for 10 weeks

10 weeks

Weekly visits for SMAs, bi-monthly produce pantry access

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Post-intervention Assessment

Participants complete post-intervention assessments and receive educational materials

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Meals

Trial Overview The study compares three groups: one receiving Medically Tailored Meals (MTM) only, another getting MTM plus Shared Medical Appointments (SMA), and a wait-list control group. It aims to see how well these interventions work in a community setting.

How Is the Trial Designed?

Group I: Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs) Experimental Treatment 1 Intervention

Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and SMA weekly for 10 weeks.

Group II: Medically Tailored Meals - Later (MTM-Later) Experimental Treatment 1 Intervention

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.

Group III: Medically Tailored Meals (MTMs) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Amanda Shallcross

Lead Sponsor

Trials

2

Recruited

220+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.

The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. Law, KK., Coyle, DH., Neal, B., et al.[2023]

Implementing national coverage for medically tailored meals (MTMs) could potentially prevent approximately 1.6 million hospitalizations and save $13.6 billion in health care costs annually for patients with diet-related diseases.

Over a 10-year period, MTM coverage could lead to an estimated 18.3 million averted hospitalizations and $484.5 billion in reduced health care expenditures, highlighting the significant cost-effectiveness of this intervention for patients with chronic diet-sensitive conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. Hager, K., Cudhea, FP., Wong, JB., et al.[2023]

In a study involving 2088 medical inpatients at nutritional risk, individualized nutritional support significantly reduced adverse clinical outcomes, including mortality, compared to standard hospital food, with a 23% adverse outcome rate in the intervention group versus 27% in the control group.

The intervention group also had a lower mortality rate (7%) compared to the control group (10%), indicating that tailored nutritional support can improve survival without increasing side effects, as both groups reported similar rates of adverse effects from nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial. Schuetz, P., Fehr, R., Baechli, V., et al.[2019]

The review discusses the nutrient composition of both standard and specialized enteral formulas designed for patients with diabetes mellitus, highlighting their tailored nutritional needs.

It also evaluates the medical efficacy of these specialized formulas in correcting clinical and metabolic disorders associated with diabetes, suggesting their potential benefits in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Methodology of use of an enteral nutrition formulas in diet therapy of patients with type 2 diabetes]. Sharafetdinov, KhKh., Meshcheriakova, VA., Plotnikova, OA.[2017]

Personalized nutrition (PN) is defined as a field that uses individual differences to create nutrition strategies aimed at preventing and managing diseases while optimizing health, emphasizing the need for a clear consensus to enhance research and clinical practice.

The field of PN can be divided into three key areas: science and data, education and training, and guidance and therapeutics, which together help healthcare professionals tailor nutrition interventions to individual needs and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. Bush, CL., Blumberg, JB., El-Sohemy, A., et al.[2021]

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

A study involving 650 patients with chronic conditions found that receiving medically tailored meals (MTM) for 2 weeks led to a significant reduction in anxiety and depression scores compared to baseline, while the 4-week group did not show similar improvements.

However, there were no significant differences in overall patient outcomes, such as activities of daily living, nutritional risk, or rates of emergency department visits and rehospitalizations, between the 2-week and 4-week MTM groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. Boxer, R., Drace, ML., Kelly, C., et al.[2023]

Medically tailored meals (MTMs) have been shown to effectively improve health outcomes for food-insecure patients with type 2 diabetes, highlighting the importance of nutrition in diabetes management.

Improving access to nutritious food through MTMs not only benefits patient health but also has the potential to reduce overall healthcare costs, suggesting a need for further research to support insurance coverage for these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. Rabaut, LJ.[2020]

Personalized nutritional support is crucial for improving patient outcomes, as it can influence therapeutic interventions, hospitalization duration, and overall prognosis.

Regular assessments of each patient's caloric needs and respiratory quotient are essential to tailor nutritional treatments effectively, helping to avoid complications from both overfeeding and underfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Individualized energy metabolic monitoring and its clinical application]. Wang, P., Guo, Q., Li, Y.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11533393/

Health outcomes reported by healthcare providers and ... We found evidence that participation in MANNA's MTM program was associated with favorable health outcomes for clients with serious illness and nutritional risk.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667276622000282

Food as medicine? Exploring the impact of providing ... Providing medically-tailored meals significantly increases dietary adherence above 90% and allows patients to realize significantly better chronic disease ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001343

A Systematic Review of “Food Is Medicine” Randomized ... Medically Tailored Meals​​ The primary outcome was all-cause rehospitalization within 90 days; participants received usual care or 10 weeks of 7 ...

4. tuftsfoodismedicine.org tuftsfoodismedicine.org/wp-content/uploads/2025/03/Food-is-Medicine-Fact-Sheet-2025.pdf

WEB_Tufts_2025_FIM Fact Sheet 2_031425 These programs provide medically tailored meals, groceries, and produce to support disease management, in combination with nutrition and culinary education, as ...

5. foodandfriends.org foodandfriends.org/news/new-studies-show-medically-tailored-meal-programs-improve-health-and-reduce-healthcare-costs/

New Studies Show Medically Tailored Meal Programs ... We have the expertise with proven results to support those most in need of medically tailored meals. This data provides us with the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11916996/

The nutritional impact of 7 versus 21 home-delivered ... We hypothesized that MTM would reduce malnutrition risk, improve diet adherence, reduce healthcare utilization and sarcopenia risk, and that 21 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06242808

Medically Tailored Groceries and Food Resource Coaching Study Overview. Brief Summary. Eating healthy foods can help people manage health problems, like Type 2 diabetes and heart disease. Many people ...