Medically Tailored Meals for Heart Failure
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Diego
Must not be taking: Insulin, Meglitinides
Disqualifiers: End-stage heart failure, Diabetes, others
No Placebo Group
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.12345
Are medically tailored meals safe for humans?
How are medically tailored meals different from other treatments for heart failure?
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
See 2 more
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.
See 8 more
Trial 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 (Nutritional Support)
Trial OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: 15 Medically Tailored Meals (MTM) + snacksExperimental Treatment1 Intervention
Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.
Group II: 14 Medically Tailored Meals (MTM)Experimental Treatment1 Intervention
Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San DiegoLa Jolla, CA
Stanford UniversityStanford, CA
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Who Is Running the Clinical Trial?
University of California, San DiegoLead Sponsor
Stanford UniversityCollaborator
References
Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]Medically tailored meals (MTM) may be beneficial to patients after hospital discharge.
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]To evaluate the impact of home-delivered, medically tailored meals and medical nutrition therapy among food-insecure patients following hospitalization for congestive heart failure by comparing clinical outcomes to a retrospectively matched cohort.
Oral nutritional supplement use in relation to length of stay in heart failure patients at a regional medical center. [2022]Improving the nutritional status of hospitalized patients has been shown to reduce length of stay (LOS), hospital costs, readmission rates, complication rates, and mortality. Provision of nutrient-rich, liquid, oral nutrition supplements (ONS) is one approach to improve nutritional status. Little information is available on ONS use and LOS among heart failure patients.
"More2Eat" in patients at nutritional risk during hospital stay lowers the risk of three-month mortality. [2023]Malnutrition is a common problem among hospitalized patients due to increased nutrient requirements and reduced food intake or uptake of nutrients. The aim of this prospective cohort study was to investigate the association of nutritional risk status (at or not at risk by NRS-2002) as well as energy and protein intake, use of oral nutritional supplements (ONS) and snack meals in at risk patients during hospitalization and adverse outcomes (length of stay (LOS), readmissions and mortality) at three-months follow-up.
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]Undernutrition is prevalent in cancer patients and associated with increased incidence of complications and mortality. We investigated the effects of a home delivery meal service, providing a selection of energy-dense, protein-rich meals, on quality of life (QoL) in malnourished lung cancer patients. Forty lung cancer patients with nutritional risk score ≥3 (NRS-2002) were randomized to control or intervention. The intervention group was offered energy- and protein-rich main meals and snacks, delivered 3 times per week. The control group continued their habitual diet. Primary endpoint, QoL, and secondary endpoints were assessed at baseline, and after 6 and 12 wk. Data on unplanned readmissions, length of hospital stay, and mortality were collected 3 and 6 mo post-intervention. Intervention group improved standard Chair Stand Test (30-s CST) after 6 and 12 wk (P
Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. [2023]'Food is medicine' strategies aim to integrate food-based nutrition interventions into healthcare systems and are of growing interest to healthcare providers and policy makers. 'Medically Tailored Meals' (MTM) is one such intervention, which involves the 'prescription' by healthcare providers of subsidized, pre-prepared meals for individuals to prevent or manage chronic conditions, combined with nutrition education.
An organizational model to translate nutritional recommendations into routine clinical practice in secondary prevention of coronary artery disease. [2013]We hypothesized that nutritional risk factors can be reduced routinely in all patients with coronary artery disease (CAD) by modifying general hospital catering into "antiatherogenic catering" and providing patients with an education program.
[A novel in-hospital meal service improves protein and energy intake]. [2018]To investigate whether a novel meal service, FoodforCare, improves dietary intake and patient satisfaction, compared to the traditional 3-meals a day service (TMS).
A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. [2019]Despite tremendous focus, effort, drug and device development and resources dedicated to the care of patients at risk for and with heart failure (HF), the epidemic continues. The HF patient presents with a widely deranged physiology and typically at the same time is malnourished adding to the disease complexity and therapeutic challenges. Most nutritional approaches for patients with HF focus on dietary restrictions (of salt and water) and lack uniformity or clarity or focus on meeting nutritional needs, barriers and deficits of the patient with HF. Finally, it seems reasonable to anticipate that any dietary program recommendation should contribute in a positive way toward HF management goals and at its foundation positively contribute to the deranged physiology. In many ways the "Dietary Approaches to Stop Hypertension" (DASH) dietary program fulfills these needs and early evidence supports the notion that the DASH diet may be optimal for patients with HF. This brief review examines some of this evidence and provides recommendations for the HF community.
[Nutrition in Case of Heart Failure]. [2022]Nutrition in Case of Heart Failure Abstract. Despite the complexity of the subject, nutritional medicine has made important advances in recent years, especially regarding cardiovascular health and for patients with heart failure. There is quite good evidence on specific diets, such as the Mediterranean and plant-based diets, but also on individual micronutrients, such as intravenous iron supplementation of iron deficiency in heart failure. No precise quantities can yet be named when dealing with the recommended amount of salt in heart failure patients, but the intake of high amounts of salt (>12 g/day) should be avoided. Considering the risk of malnutrition in this vulnerable patient population, an individualized nutritional therapy is advisable for some patients. This requires targeted screening for malnutrition. Nutritional medicine research still lacks many answers to further questions regarding heart failure patients. More randomized controlled trials and their meta-analyses are therefore required. Studies available so far have - among other shortcomings - paid too little attention to differences in nutrition in the different types and stages of heart failure. Interdisciplinary collaboration between cardiologists, hospital internists, general practitioners and nutritional therapists is in any case crucial for optimal treatment of patients with heart failure.
Development and testing of the feasibility and acceptability of a tailored dietary intervention in patients with heart failure. [2015]The aim of this study was to describe how to develop a theory-based tailored dietary intervention (TADI) and test its feasibility and acceptability in patients with heart failure (HF).
Nutritional Interventions in Heart Failure: A Systematic Review of the Literature. [2018]Heart failure (HF) is a major health care burden and there is a growing need to develop strategies to maintain health and sustain quality of life in persons with HF. The purpose of this review is to critically appraise the components of nutrition interventions and to establish an evidence base for future advances in HF nutrition research and practice.