Medically Tailored Meals for Healthy Eating

(FAME-F Trial)

Overseen By Patricia Knoepp, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Psychosis, Major psychiatric illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether delivering medically tailored meals benefits just one person or the entire household more effectively, and whether a dedicated driver or a commercial shipper is more efficient. Participants will receive meals tailored to specific health needs, delivered either to the individual or their entire household. The trial suits individuals who control their dietary choices and can safely store meals at home, with no plans to relocate in the next six months.

As an unphased trial, participants can contribute to innovative research that may enhance meal delivery methods for health benefits.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that medically tailored meals (MTMs) are generally safe and well-received. For example, a study of MANNA's MTM program found positive health results in people with serious illnesses and nutritional needs, indicating that the meals are not only safe but also beneficial. Another study demonstrated that providing MTMs significantly reduced healthcare costs and hospital visits, suggesting that people handled the meals well without major issues. While these studies focused on health effects, the consistently positive results confirm the safety of MTMs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of medically tailored meals on healthy eating, offering personalized nutrition solutions. Unlike standard meal delivery services, this trial compares different delivery methods, such as using a dedicated driver employed by Community Servings versus a commercial shipping organization. Additionally, the trial evaluates the benefits of feeding just the individual versus the entire household, which could provide insights into the broader effects of nutrition on family health dynamics. By testing these varied approaches, the trial aims to discover the most effective strategies for improving dietary habits and health outcomes.

What evidence suggests that this trial's treatments could be effective?

Research has shown that meals specifically designed for medical needs, known as medically tailored meals (MTMs), can improve health for people with serious illnesses. Studies have found that these meals make it easier to maintain a healthy diet and reduce the stress of cooking. Evidence also suggests that MTMs can lower hospital visits and healthcare costs, saving thousands of dollars per patient in most U.S. states. In this trial, participants will receive MTMs either for themselves or their entire household, delivered by a dedicated driver or a commercial shipper. These benefits apply whether the meals are for one person or an entire family. Overall, MTMs offer a promising way to support health through better nutrition. ^{1 2 3 5 6}

Who Is on the Research Team?

Seth A Berkowitz, MD MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals who can control their diet, won't move away soon, and can consent to participate in English or Spanish. It's not for those without a stable place to live and store meals, no phone access, or major psychiatric conditions that hinder participation.

Inclusion Criteria

Free living to the extent that participant has control over dietary intake

Willing and able to provide written informed consent and participate in all study activities

I can complete study tasks in English or Spanish.

Exclusion Criteria

I do not have a stable place to live or keep food safely.

Lack of telephone

Known psychosis or major psychiatric illness that prevents participation with study activities

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 with different strategies and delivery methods

12 weeks

Weekly meal deliveries

Follow-up

Participants are monitored for diet quality, loneliness, and food security after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Commercial Shipper
• Dedicated Driver
• Feed the Household
• Feed the Individual

Trial Overview The study is testing whether medically tailored meals should be given to just one person or the whole family and how they should be delivered—by a dedicated driver or through commercial shipping—to guide future food-as-medicine studies.

How Is the Trial Designed?

Group I: Feed the household; Dedicated driver Active Control 2 Interventions

Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household; Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings

Group II: Feed the individual; Dedicated driver Active Control 2 Interventions

Medically tailored meals will be provided for the enrolled individual; Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings

Group III: Feed the individual; Commercial shipper Active Control 2 Interventions

Medically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization

Group IV: Feed the household; Commercial shipper Active Control 2 Interventions

Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household; Meals will be delivered by a commercial shipping organization

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Community Servings

Collaborator

Trials

4

Recruited

510+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Community Servings

Collaborator

Trials

4

Recruited

510+

Published Research Related to This Trial

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

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]

Home-delivered meals provided over 5 consecutive days for 6 years did not consistently meet federal guidelines for meal patterns, serving sizes, and food temperatures, indicating potential safety and nutritional concerns.

Despite some deficiencies, these meals contributed significantly to the nutritional needs of recipients, with certain nutrients like protein and iron often exceeding 33% of the Recommended Dietary Allowance (RDA), while others like calcium consistently fell short.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-delivered meals: food quality, nutrient content, and characteristics of recipients. Asp, EH., Darling, ME.[2006]

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]

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]

The Visiting Nurse Service HIV/Home Delivered Meals Program provided 50 clients with HIV/AIDS energy-enhanced meals and nutrition support over 6 months, leading to improved food consumption and weight management for many participants.

Out of 35 participants assessed, 13 gained weight on average by 6 pounds, and the program helped increase the number of participants considered to be 'doing well' from 14 to 19, demonstrating the effectiveness of dietitian-led medical nutrition therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based, interagency approach by dietitians to provide meals, medical nutrition therapy, and education to clients with HIV/AIDS. Topping, CM., Humm, DC., Fischer, RB., et al.[2006]

A study involving 148 patients in Spain identified that the most important characteristics of home enteral nutrition (HEN) are its adaptation to comorbidities and tolerability, each accounting for 33% of patient preferences.

There was a moderate to good concordance between patients and caregivers regarding HEN preferences, indicating that caregivers generally understand their patients' needs well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preferences for the attributes of home enteral nutrition (HEN) in Spain. Do caregivers know their patients' preferences?] Olveira, G., Martínez-Olmos, MÁ., Fernández de Bobadilla, B., et al.[2018]

Personalized nutrition (PN) is defined as a field that uses individual differences to create nutrition strategies aimed at preventing and managing diseases while optimizing health, emphasizing the need for a clear consensus to enhance research and clinical practice.

The field of PN can be divided into three key areas: science and data, education and training, and guidance and therapeutics, which together help healthcare professionals tailor nutrition interventions to individual needs and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. Bush, CL., Blumberg, JB., El-Sohemy, A., et al.[2021]

There is a growing recognition that food impacts bodily functions beyond just providing calories, yet much of the information available to consumers about food and diets is unverified for safety and efficacy.

The paper suggests a framework for improving research and development in food safety and health benefits, emphasizing the need for regulatory oversight and addressing patent issues to support long-term investment in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional products as drugs or food implications for development. Richards, DJ.[2008]

Citations

1. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... This study investigated the one-year and five-year effects of implementing MTMs in US states on hospitalizations, health care expenditures, and net costs.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11916996/

The nutritional impact of 7 versus 21 home-delivered ... All reported that the meals reduced their stress in meal preparation, 94% reported the meals helped them follow their HF diet, 71% reported the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11533393/

Health outcomes reported by healthcare providers and ... We found evidence that participation in MANNA's MTM program was associated with favorable health outcomes for clients with serious illness and nutritional risk.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2797397

Medically Tailored Meals and Estimated Hospitalizations ... These prior findings suggest that MTMs may be associated with improved health through several pathways, including improved nutrition, improved ...

5. fimcoalition.org fimcoalition.org/news_and_events/new-study-finds-medically-tailored-meals-are-cost-saving-across-the-u-s/

New Study Finds Medically Tailored Meals Are Cost- ... The intervention was estimated to be cost-saving in 49 states and cost-neutral in one state, with cost savings ranging from $6,299 per patient ( ...

6. foodandfriends.org foodandfriends.org/news/new-studies-show-medically-tailored-meal-programs-improve-health-and-reduce-healthcare-costs/

New Studies Show Medically Tailored Meal Programs ... The other study was conducted with Maryland's Community Health Services Commission (CHRC), which reported outcome data for 58 clients over 24 ...