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

75 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Medically Tailored Meals for Metabolic Health?

Research suggests that medically tailored meals, which are pre-prepared meals prescribed by healthcare providers, can help manage chronic conditions like type 2 diabetes by integrating nutrition into healthcare. These meals may also benefit patients after hospital discharge, potentially improving their recovery. ^{1 2 3 4 5}

Is it safe for humans to use medically tailored meals?

The available research does not specifically address safety concerns, but medically tailored meals are generally considered safe as they are designed to provide appropriate nutrition for managing chronic conditions. ^{1 2 6 7 8}

How is the treatment of Medically Tailored Meals different from other treatments for metabolic health?

Medically Tailored Meals are unique because they involve healthcare providers prescribing pre-prepared meals specifically designed to manage or prevent chronic conditions, combined with nutrition education. This approach integrates food as a form of medicine, which is different from traditional treatments that may rely more on medication or supplements. ^{1 2 7 9 10}

What is the purpose of this trial?

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.

Research Team

Amanda Shallcross

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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. Participants will also have access to bi-monthly fresh produce pantry, where fresh produce will be guaranteed and available to them for pick-up.

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]

2. United States 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[Individualized energy metabolic monitoring and its clinical application]. [2006]

6. England 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. [2020]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Methodology of use of an enteral nutrition formulas in diet therapy of patients with type 2 diabetes]. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

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