Medically Tailored Meals for Heart Failure and Malnutrition

Overseen By Amy Sun, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Heart failure stage 4, CKD stage 5, others

Compensation: Varies

Number of Visits: 30

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine whether providing either just dinner meals or all meals daily to individuals with heart failure and malnutrition more effectively improves their health. It examines whether these meal plans, known as Medically Tailored Meals, can reduce the risk of malnutrition and decrease unexpected hospital visits and readmissions. The trial tests two groups: one receiving three meals a day and the other receiving only dinner. Individuals diagnosed with heart failure, at risk of malnutrition, and residing within the MANNA delivery area may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to enhance understanding of how meal plans can improve health outcomes for those with heart failure.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this protocol is safe for patients with heart failure and malnutrition?

Research shows that medically tailored meals (MTMs) are generally safe and well-received by patients. These meals, designed to meet specific dietary needs, have been linked to better health outcomes for conditions like heart failure and diabetes. For example, one study found that MTMs helped reduce the risk of hospital visits for heart failure. Another study associated these meals with lower overall death rates among patients.

While specific reports of negative effects from MTMs are absent, the focus remains on their positive health benefits rather than safety concerns. The lack of negative safety data suggests these meals are safe to eat. Those interested in participating should consult their healthcare provider to ensure it's the right choice for their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about medically tailored meals for heart failure and malnutrition because they offer a personalized approach to nutrition, potentially improving patient outcomes more effectively than standard diet recommendations. Unlike typical treatments that focus primarily on medication and lifestyle changes, these meals are specifically designed to meet the unique dietary needs of heart failure patients, ensuring they receive the right balance of nutrients. This tailored nutritional support could help reduce hospital readmissions and enhance quality of life by addressing malnutrition directly, which is often an overlooked aspect of heart failure management. Additionally, delivering these meals straight to patients' homes adds a layer of convenience that can improve adherence and make managing their condition more feasible.

What evidence suggests that medically tailored meals are effective for heart failure and malnutrition?

Research has shown that specially prepared meals for medical needs can greatly help people with heart failure by improving nutrition and reducing hospital readmissions. Specifically, these meals lower the chances of needing to return to the hospital or visit the emergency room. In this trial, participants will be randomized to receive either 21 or 7 medically tailored meals per week. Patients receiving these meals often experience better health outcomes than those who do not. While the number of meals may vary, the overall benefit remains clear: better nutrition leads to fewer health problems. ^{1 2 3 5 6}

Who Is on the Research Team?

Charlene Compher

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure (NYHA Class 1-3/ACC/AHA Stage C) who are at risk of malnutrition or already malnourished. Participants must live where MANNA delivers meals.

Inclusion Criteria

You live in the area where MANNA delivers.

I have heart failure and am at risk of or currently experiencing moderate to severe malnutrition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 7 or 21 medically tailored meals per week delivered to their homes for four weeks

4 weeks

Weekly meal delivery, telephone visits at day 0, 30, and 60

Crossover Treatment

Participants switch to the alternate meal delivery plan (7 or 21 meals per week) for another four weeks

4 weeks

Weekly meal delivery, telephone visits at day 30 and 60

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Meals

Trial Overview The study compares two meal delivery frequencies to see which is better for improving nutrition in heart failure patients: one group will receive seven weekly meals, and the other will get twenty-one. The trial also looks at emergency visits and hospital readmissions.

How Is the Trial Designed?

Group I: 21 medically-tailored meals per week Active Control 1 Intervention

Patients will be randomized to three medically tailored dinner meals each day delivered to their homes for four weeks.

Group II: 7 medically-tailored meals per week Placebo Group 1 Intervention

Patients will be randomized to medically tailored dinner meals delivered to their homes for four weeks.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06142903

Comparative Effectiveness of 7 Versus 21 Home-delivered ... This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or ...

2. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... First, we restricted the receipt of MTMs to people with diabetes or congestive heart failure. Second, we modeled 50 percent of eligible ...

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

The nutritional impact of 7 versus 21 home-delivered ... The nutritional impact of 7 versus 21 home-delivered medically tailored meals in patients with heart failure and malnutrition risk: a random ...

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.038438

Exploring Facilitators and Barriers of Medically Tailored ... Acute heart failure (AHF) is associated with high rehospitalization, morbidity, and mortality rates. Implementing medically tailored meal ...

5. journals.lww.com journals.lww.com/lww-medicalcare/fulltext/2022/10000/effect_of_medically_tailored_meals_on_clinical.4.aspx

Effect of Medically Tailored Meals on Clinical Outcomes in... Secondary outcomes included hospitalization for heart failure ... medically tailored meals; clinical trial; heart failure; diabetes; chronic kidney disease ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9451942/

Effect of Medically Tailored Meals on Clinical Outcomes in ... In exploratory analyses, MTMs were linked to lower all-cause mortality in all groups and a lower risk of being hospitalized for heart failure in ...