Medically Tailored Meals for Metabolic Health
(NOURISH HEARTS Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAmanda Shallcross
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Amanda Shallcross
Disqualifiers: Heart failure, Type I diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is a human-centered, three-arm, parallel-group, randomized control, implementation trial (n=75) to compare MTM (Medically Tailored Meals) only (14 meals delivered weekly for 10 weeks) vs. MTM + SMA (Shared Medical Appointments; once weekly sessions for 10 weeks) vs. a wait-list control group (MTM-Later) in patients with hypertension, type 2 diabetes, obesity, and/or metabolic syndrome. All intervention components will be culturally congruent (e.g., MTMs will include food that converges with culturally relevant diets and SMAs will be delivered by individuals with racial concordance to the target community). Primary outcomes will be implementation (recruitment and retention rates) and feasibility (engagement and satisfaction). Participants will be recruited from Cleveland Clinic's South Pointe Hospital in Warrensville Heights, a predominantly Black community with low socioeconomic status and high cardiovascular disease morbidity.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Medically Tailored Meals for Metabolic Health?
Research suggests that medically tailored meals, which are pre-prepared meals prescribed by healthcare providers, can help manage chronic conditions like type 2 diabetes by integrating nutrition into healthcare. These meals may also benefit patients after hospital discharge, potentially improving their recovery.
12345Is it safe for humans to use medically tailored meals?
The available research does not specifically address safety concerns, but medically tailored meals are generally considered safe as they are designed to provide appropriate nutrition for managing chronic conditions.
12678How is the treatment of Medically Tailored Meals different from other treatments for metabolic health?
Medically Tailored Meals are unique because they involve healthcare providers prescribing pre-prepared meals specifically designed to manage or prevent chronic conditions, combined with nutrition education. This approach integrates food as a form of medicine, which is different from traditional treatments that may rely more on medication or supplements.
127910Eligibility Criteria
This trial is for Black or African American adults over 18 with hypertension, type 2 diabetes, metabolic syndrome, or obesity. They must have been treated at Cleveland Clinic South Pointe Hospital recently and be able to use a web-enabled device in English.Inclusion Criteria
I identify as Black or African American.
I have been treated at Cleveland Clinic South Pointe Hospital in the last 6 months.
I can speak and read English.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Medically Tailored Meals (MTMs) or MTMs + Shared Medical Appointments (SMAs) for 10 weeks
10 weeks
Weekly visits for SMAs, bi-monthly produce pantry access
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Post-intervention Assessment
Participants complete post-intervention assessments and receive educational materials
1 week
Participant Groups
The study compares three groups: one receiving Medically Tailored Meals (MTM) only, another getting MTM plus Shared Medical Appointments (SMA), and a wait-list control group. It aims to see how well these interventions work in a community setting.
3Treatment groups
Experimental Treatment
Active Control
Group I: Medically Tailored Meals+ Shared Medical Appointments (MTMs + SMAs)Experimental Treatment1 Intervention
Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and SMA weekly for 10 weeks. Participants will also have access to bi-monthly fresh produce pantry, where fresh produce will be guaranteed and available to them for pick-up.
Group II: Medically Tailored Meals - Later (MTM-Later)Experimental Treatment1 Intervention
Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks and educational materials (e.g., relevant handouts from the SMA) after the completion of the post intervention study assessment. This group will act as our Waitlist Control group.
Group III: Medically Tailored Meals (MTMs)Active Control1 Intervention
Participants will receive 2 meals per day for 7 days a week for a duration of 10 weeks. Individuals randomized to MTMs will receive electronic educational materials from the MTM + SMA group after the completion of the post-intervention study assessment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
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Who Is Running the Clinical Trial?
Amanda ShallcrossLead Sponsor
American Heart AssociationCollaborator
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.
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.
[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).
Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial. [2019]Guidelines recommend the use of nutritional support during hospital stays for medical patients (patients not critically ill and not undergoing surgical procedures) at risk of malnutrition. However, the supporting evidence for this recommendation is insufficient, and there is growing concern about the possible negative effects of nutritional therapy during acute illness on recovery and clinical outcomes. Our aim was thus to test the hypothesis that protocol-guided individualised nutritional support to reach protein and caloric goals reduces the risk of adverse clinical outcomes in medical inpatients at nutritional risk.
[Individualized energy metabolic monitoring and its clinical application]. [2006]The nutritional status affects the factors of patient outcome such as the therapeutic intervention, the length of hospitalization and prognosis. Personalization of nutritional support treatments can minimize the complications that may arise from overfeeding and underfeeding. Appropriate nutritional support requires an individual nutrition assessment based on each patient's caloric and regularly monitored respiratory quotient to accommodate continuing changes in the patient's condition.
"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]Medically-tailored meal programs that provide home-delivered medically-appropriate food are an emerging intervention when type 2 diabetes co-occurs with food insecurity (limited or uncertain access to nutritious food owing to cost). We sought to understand the experiences of medically-tailored meal program participants.
Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. [2023]Medically tailored meals (MTMs) are associated with lower health care utilization among patients with complex diet-related diseases but are not a covered benefit in Medicare or Medicaid. The potential impact of extending insurance coverage for MTMs nationally remains unknown.
Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]Personalized nutrition holds tremendous potential to improve human health. Despite exponential growth, the field has yet to be clearly delineated and a consensus definition of the term "personalized nutrition" (PN) has not been developed. Defining and delineating the field will foster standardization and scalability in research, data, training, products, services, and clinical practice; and assist in driving favorable policy. Building on the seminal work of pioneering thought leaders across disciplines, we propose that personalized nutrition be defined as: a field that leverages human individuality to drive nutrition strategies that prevent, manage, and treat disease and optimize health, and be delineated by three synergistic elements: PN science and data, PN professional education and training, and PN guidance and therapeutics. Herein we describe the application of PN in these areas and discuss challenges and solutions that the field faces as it evolves. This and future work will contribute to the continued refinement and growth of the field of PN.Teaching pointsPN approaches can be most effective when there is consensus regarding its definition and applications.PN can be delineated into three main areas of application: PN science and data, PN education and training, PN guidance and therapeutics.PN science and data foster understanding about the impact of genetic, phenotypic, biochemical and nutritional inputs on an individual's health.PN education and training equip a variety of healthcare professionals to apply PN strategies in many healthcare settings.PN professionals have greater ability to tailor interventions via PN guidance and therapeutics.Favorable policy allows PN to be more fully integrated into the healthcare system.
[Methodology of use of an enteral nutrition formulas in diet therapy of patients with type 2 diabetes]. [2017]In this review the nutrient structure of standard and specialized enteral formulas for patients with diabetes mellitus is given and the data about medical efficacy specialized enteral formulas in correction of clinical and metabolic disorders in this contingent of patients are discussed.
Medically Tailored Meals as a Prescription for Treatment of Food-Insecure Type 2 Diabetics. [2020]Type 2 diabetes mellitus is an immense burden to the health of our population and to our current health care system, and the weight of this burden is only projected to multiply in coming years. A nutritious diet is an indispensable aspect of diabetes treatment, and the lack of access to food engenders poor disease-state control, which correlates with increased health care utilization. Interventions aimed at improving access to food through medically tailored meals (MTMs) have demonstrated effectiveness in improving the health of food-insecure type 2 diabetic patients and reducing health care costs. Further studies are necessary to increase the external validity of existing positive research on medically tailored meals in food-insecure diabetic patients and to provide evidence to support potential policy changes under which the costs of medically tailored meals for diabetics might be covered by insurers.