Medically-Tailored Meals (MTMs) for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tufts Medical Center, Boston, MA
Heart Failure+1 More
Medically-Tailored Meals (MTMs) - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether medically tailored meals can help improve nutrition and quality of

See full description

Eligible Conditions

  • Heart Failure
  • Malnutrition

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Medically-Tailored Meals (MTMs) will improve 5 primary outcomes and 3 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of Change from start to end of 12-week MTM period.

Change from start to end of 12-week MTM period
6 minute walk test
Diet Satisfaction scale (DSat-28)
Facilitated food recall
Handgrip strength measurement in kg
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Short Nutritional Assessment Questionnaire (SNAQ)
Sit-to-stand test
Weight

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

12 weeks of protein supplementation shakes
1 of 2
12 weeks of medically-tailored meals (MTMs)
1 of 2
Experimental Treatment

This trial requires 16 total participants across 2 different treatment groups

This trial involves 2 different treatments. Medically-Tailored Meals (MTMs) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

12 weeks of protein supplementation shakes
DietarySupplement
Participants will receive 1 bottle of Ensure Max Protein shake every day (any flavor option without caffeine, daily for 12 weeks) to take in addition to their standard diet, without MTM delivery.
12 weeks of medically-tailored meals (MTMs)
Other
12 weeks of home-delivered medically-tailored meals (MTMs), prepared and delivered by the non-profit Community Servings. The MTM has be developed specifically for patients with heart failure, with an approximate protein intake range of 1.1-1.5 g/kg body weight/day and a maximum of 2000 mg sodium/day.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from start to end of 12-week mtm period
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from start to end of 12-week mtm period for reporting.

Closest Location

Tufts Medical Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Heart Failure or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Systolic heart failure (left ventricular ejection fraction </=40%), with New York Heart Association (NYHA) class II-III symptoms
At least one prior hospitalization in the preceding 12 months
Evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more)
Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the MTM deliveries
Able and willing to sign study consent
18 years or above
Not currently pregnant and not imminently planning a pregnancy

Patient Q&A Section

Who should consider clinical trials for heart failure?

"Given these results, our data suggest that patients with moderate functional limitations, who have low to no comorbidities and who do not have contraindications to a clinical trial may be considered." - Anonymous Online Contributor

Unverified Answer

How many people get heart failure a year in the United States?

"Each year, around 2 million adults in the United States are diagnosed with new Type I or Type II diabetes. This makes up 2.1% of American adults. Around 2 million new cases of heart failure are diagnosed a year in the United States. This makes it the most common cause of heart failure in adults." - Anonymous Online Contributor

Unverified Answer

What is heart failure?

"In the US, 1 in 4 adults has heart failure. This condition will negatively affect a person's quality of life, cause them to go into bankruptcy and result in a reduced life expectancy." - Anonymous Online Contributor

Unverified Answer

What causes heart failure?

"The causes of heart disease and heart failure are manifold. Heart disease is often referred to as a “cardiovascular disease.” The underlying causes of heart disease and heart failure are quite different, and are not interchangeable. Even where the etiology is known, it is possible to treat heart failure as a cardiogenic shock, as it is not only due to an inability to pump blood efficiently, but there is an underlying disease process." - Anonymous Online Contributor

Unverified Answer

Can heart failure be cured?

"The data suggest that neither the degree of myocardial damage, nor the degree of cardiac dysfunction can be considered to be curable with current pharmacologic therapy. The best treatment for heart failure is determined by a multidisciplinary approach, combining knowledge of the pathophysiology of heart failure (in other words, the mechanisms underlying dysfunction of the heart), optimal patient selection and treatment as determined by clinical parameters." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart failure?

"What signs may be present in heart failure are usually progressive and include shortness of breath, palpitation and low blood pressure. Many, if not most, patients with heart failure have systemic symptoms. Systemic symptoms can include fatigue, feeling tired, difficulty sleeping, increased sweating or weight loss and are common. Signs of heart failure in childhood may not become apparent until heart failure develops as an adulthood illness.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart failure?

"In addition to ACE inhibitors, beta-blockers are one of a number of common treatments for HF management. Although ACE inhibition may increase survival in some patients with HF and improved cardiac function, it may also increase deaths of patients with poor heart function. In addition, diuretics can be harmful in HF, so avoiding their use when possible is advisable." - Anonymous Online Contributor

Unverified Answer

What is the latest research for heart failure?

"A small number of published systematic reviews were eligible for our analyses. To our knowledge, this is one of the largest, and the only systematic review to incorporate the most recent research in the heart failure field. Data from a recent study are limited in the following ways: 1) some reviews may have omitted studies with some relevant results; 2) other reviews may have omitted some pertinent results; and 3) the studies which were included in these reviews may have undergone a higher degree of journal peer review, and hence be more highly cited than other studies. The lack of such considerations in this review may limit its applicability in the current era." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of heart failure?

"A substantial proportion of heart failure patients presenting for care at our institution are of advanced age. While CAD was the most common etiology of heart failure in this large, multi-institution study, the contribution of CAD to heart failure did not increase with age. In this age group, heart failure may be related to coronary heart disease, but is not the result of coronary heart disease. These observations may have important implications for the management of patients with heart failure, particularly those in the elderly." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in medically-tailored meals (mtms) for therapeutic use?

"The treatment of cachexia is an area that has only recently been tackled by therapeutic methods, and as yet little is known of treatment options. In this context, MTMs will have an important role, both in the therapy of other diseases (e.g. obesity or cachexia), and in its own right. At present, clinical applications for MTMs are currently limited. Results from a recent paper of a large multicenter study were presented at the annual congress of the European Society for Parenteral and Enteral Nutrition in 2003. In particular the possibility is mentioned of investigating MTMs, aimed at prevention and treatment of cachexia, as an alternative or, alternatively, combination of the treatment of rheumatic diseases." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating heart failure?

"Although we understand the clinical importance of treating heart failure, there have been few changes in our management. This may reflect a lack of relevant research or the fact the drugs currently available are inadequate to deal with chronic heart failure." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets heart failure?

"Cardiac heart failure occurs in people of almost any age. However, the average age at diagnosis is 71, with more women diagnosed than men at 62 years old and more people over 80 years old getting diagnosed by a specialist than getting one found elsewhere." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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