Medically Tailored Meals for Heart Failure

Not currently recruiting at 1 trial location

Overseen By Valerie Mercer, MPH, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Insulin, Meglitinides

Disqualifiers: End-stage heart failure, Diabetes, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how eating specially designed meals, known as Medically Tailored Meals, could help people with heart disease improve their diet. Participants will receive either 14 or 15 meals a week, along with snacks, for 12 weeks. The goal is to determine if these meals can lead to better eating habits by the end of the study. It suits those living in San Diego or the Bay Area who have congestive heart failure and feel their current diet could be healthier. As an unphased trial, this study offers a unique opportunity to contribute to innovative dietary research that could improve heart health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking insulin or meglitinides.

What prior data suggests that medically tailored meals are safe for people with heart disease?

Research has shown that meals specifically designed for medical needs, known as medically tailored meals (MTMs), are generally well-received by individuals with heart failure. These meals meet the nutritional requirements of those with specific health conditions. Studies suggest that MTMs can improve health by reducing hospital readmissions for heart failure patients.

MTMs are low in salt and high in nutrients, which is crucial for managing heart problems. Reports of negative effects from these meals have been minimal. Instead, they assist individuals in adhering to a heart-healthy diet, which can be challenging to maintain independently. This suggests that MTMs are a safe and effective option for managing heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about medically tailored meals (MTM) for heart failure because they offer a personalized approach to nutrition that standard medications and treatments cannot provide. Unlike typical heart failure treatments that often involve drugs or surgical procedures, MTM focuses on providing meals specifically designed to meet the individual dietary needs of heart failure patients. This approach not only aids in managing the condition by reducing sodium and fluid intake but also improves overall nutrition, which can enhance strength and energy levels. Additionally, receiving 15 meals plus snacks or 14 meals weekly for 12 weeks removes the burden of meal planning and preparation, making it easier for patients to adhere to a heart-healthy diet.

What evidence suggests that medically tailored meals could be effective for heart disease?

This trial will evaluate the impact of medically tailored meals (MTMs) on heart failure patients. Participants will receive either 15 MTMs plus snacks per week or 14 MTMs per week for 12 weeks. Research has shown that MTMs, specially prepared to meet specific health needs like being low in salt and high in nutrients, can benefit people with heart failure. Studies have found that those who consume these meals have fewer hospital visits and a lower risk of dying from any cause. Specifically, one study found that MTMs can reduce the chances of hospital readmission for heart failure patients. Overall, evidence suggests that MTMs improve health outcomes for those with heart problems. ^{1 2 4 6 7}

Who Is on the Research Team?

Cheryl Anderson, PhD, MPH, MS

Principal Investigator

UC San Diego

Christopher Gardner, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with heart disease, specifically those diagnosed with heart failure or congestive heart failure. The details of the inclusion and exclusion criteria are not provided, but typically participants would need to meet certain health conditions.

Inclusion Criteria

Current diet can be improved

Willing to eat all meals provided by the study

Willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Current smoker or tobacco use within the past year

Planning to leave San Diego or the Bay Area during the course of the study

Unable to communicate reasonably well either orally or through written material in 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) for 12 weeks

12 weeks

Weekly meal delivery

Follow-up

Participants are monitored for changes in diet quality and food security

12 weeks

In-person visits at Week 12 and Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Meals

Trial Overview The study is testing whether providing 14 or 15 medically tailored meals per week can improve the quality of diet in patients with heart failure over a period of twelve weeks, measured by the 'Healthy Eating Index'.

How Is the Trial Designed?

Group I: 15 Medically Tailored Meals (MTM) + snacks Experimental Treatment 1 Intervention

Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.

Group II: 14 Medically Tailored Meals (MTM) Experimental Treatment 1 Intervention

Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

Specific diets, like the Mediterranean and plant-based diets, along with intravenous iron supplementation for iron deficiency, have shown promise in improving cardiovascular health for patients with heart failure.

Individualized nutritional therapy is recommended to address the risk of malnutrition in heart failure patients, highlighting the need for targeted screening and interdisciplinary collaboration among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition in Case of Heart Failure]. Mueller, M., Siegenthaler, J., Fäh, D., et al.[2022]

A home delivery meal service providing energy-dense, protein-rich meals significantly improved quality of life and lower body strength in 40 malnourished lung cancer patients over 12 weeks.

Patients receiving the meal service showed better performance scores and increased hand grip strength, indicating that enhanced nutrition can positively impact functional status in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of a Home Delivery Meal Service of Energy- and Protein-Rich Meals on Quality of Life in Malnourished Outpatients Suffering from Lung Cancer: A Randomized Controlled Trial. Leedo, E., Gade, J., Granov, S., et al.[2018]

Educational nutrition interventions can significantly improve patient outcomes in heart failure, such as adherence to dietary restrictions and reduced readmission rates, based on a review of 17 randomized controlled trials.

While clinical guidelines recommend a low-sodium diet, evidence suggests that it may not always be beneficial, indicating a need for further research into macronutrients and overall food quality in heart failure nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Interventions in Heart Failure: A Systematic Review of the Literature. Abshire, M., Xu, J., Baptiste, D., et al.[2018]

Patients identified as at nutritional risk during hospitalization had significantly worse outcomes, including longer hospital stays, higher readmission rates, and increased mortality compared to those not at risk, based on a study of 318 patients.

Increased energy and protein intake during hospitalization was associated with lower mortality rates in at-risk patients, highlighting the importance of nutritional care in improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"More2Eat" in patients at nutritional risk during hospital stay lowers the risk of three-month mortality. Mikkelsen, S., Tobberup, R., Skadhauge, LB., et al.[2023]

The tailored dietary intervention (TADI) for heart failure patients showed high acceptability, with patient satisfaction scores reaching 100% in several sessions, indicating that participants found the program helpful and engaging.

The intervention successfully reduced mean dietary sodium intake from 2.38 g/d to 1.30 g/d among participants, demonstrating its potential efficacy in managing sodium consumption in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of the feasibility and acceptability of a tailored dietary intervention in patients with heart failure. Heo, S., Moser, DK., Lennie, TA., et al.[2015]

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]

A 21-day study involving 80 male patients with coronary artery disease showed that a diet with 20% energy from lipids significantly reduced total cholesterol, LDL cholesterol, and triglycerides compared to a control diet with 30% energy from lipids.

The implementation of an 'antiatherogenic catering' approach, combined with an educational program, effectively lowered nutritional risk factors in CAD patients without the need for individual counseling, suggesting a practical method for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An organizational model to translate nutritional recommendations into routine clinical practice in secondary prevention of coronary artery disease. Aquilani, R., Boni, S., Verdirosi, S., et al.[2013]

The study evaluated the effects of home-delivered, medically tailored meals on food-insecure patients after hospitalization for congestive heart failure, involving 39 participants compared to a matched cohort of 117 patients.

While participants showed a slight reduction in body mass index and an increase in blood pressure, these changes were not statistically significant; however, there was a trend suggesting that the intervention may improve dietary habits and potentially reduce blood pressure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Belak, L., Owens, C., Smith, M., et al.[2022]

In a study of 570 heart failure inpatients, the use of oral nutrition supplements (ONS) was linked to a higher length of stay (LOS) in the hospital, with an odds ratio of 2.43, suggesting that ONS alone may not effectively reduce LOS.

Factors such as comorbidity, discharge destination, and dietitian consultations also influenced LOS, indicating that a comprehensive approach is needed to improve care and reduce hospital stays for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral nutritional supplement use in relation to length of stay in heart failure patients at a regional medical center. Babb, EB., Rohrer, J.[2022]

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]

Heart failure (HF) patients often face complex challenges due to deranged physiology and malnutrition, making effective nutritional strategies crucial for their care.

The DASH (Dietary Approaches to Stop Hypertension) diet may be particularly beneficial for HF patients, as it aligns with the need for a dietary program that supports both nutritional needs and HF management goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. Rifai, L., Silver, MA.[2019]

Citations

1. 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 ...

2. 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 ...

3. 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 ...

4. 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1071916424009588/pdf

Medically Tailored Meals in Heart Failure: A Systematic ... Medically tailored meals (MTMs) can potentially improve outcomes in patients with heart failure (HF). •. Low-sodium, nutrient-dense MTMs can reduce readmissions ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9528877/

The impact of medically tailored meals and nutrition ... Given that adherence to a healthy diet is essential for heart failure management, food insecure patients with CHF are at heightened risk for poor disease ...

7. 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... Certain common conditions such as heart failure, diabetes, and chronic kidney disease are considered nutrition sensitive and associated with adverse clinical ...