Medically Tailored Meals for Heart Failure

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."

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 data supports the effectiveness of the treatment Medically Tailored Meals for Heart Failure?

Research shows that medically tailored meals can help improve health outcomes for patients with heart failure by providing necessary nutrition, which may reduce hospital readmissions and improve overall health. Additionally, similar approaches in other conditions, like lung cancer, have shown improvements in quality of life and reduced complications. ^{1 2 3 4 5}

Are medically tailored meals safe for humans?

Medically tailored meals have been studied in various settings, including for patients with heart failure and type 2 diabetes, and are generally considered safe as they are designed to meet specific nutritional needs and are prescribed by healthcare providers. ^{1 2 6 7 8}

How are medically tailored meals different from other treatments for heart failure?

Medically tailored meals are unique because they provide personalized nutrition support delivered to patients' homes, focusing on meeting specific dietary needs and addressing malnutrition, unlike other treatments that often emphasize dietary restrictions without personalization. ^{2 9 10 11 12}

Research Team

Cheryl Anderson, PhD, MPH, MS

Principal Investigator

UC San Diego

Christopher Gardner, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

Living in San Diego or the Bay Area of California

Exclusion Criteria

I have been diagnosed with advanced heart failure.

Current smoker or tobacco use within the past year

I have been diagnosed with type 1 diabetes or my type 2 diabetes is not under control.

Timeline

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

Treatment Details

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'.

Participant Groups

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+

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

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

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

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

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

"More2Eat" in patients at nutritional risk during hospital stay lowers the risk of three-month mortality. [2023]

5. United States 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. [2018]

6. 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]

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

An organizational model to translate nutritional recommendations into routine clinical practice in secondary prevention of coronary artery disease. [2013]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Nutrition in Case of Heart Failure]. [2022]

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

Development and testing of the feasibility and acceptability of a tailored dietary intervention in patients with heart failure. [2015]

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

Nutritional Interventions in Heart Failure: A Systematic Review of the Literature. [2018]