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

104 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to determine the appropriate target of medically tailored meals (a particular individual vs. the entire household) and means of delivery (a dedicated delivery driver vs. a commercial shipper), to inform subsequent medically tailored meal trials.

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.

What data supports the idea that Medically Tailored Meals for Healthy Eating is an effective treatment?

The available research shows that Medically Tailored Meals (MTM) can be beneficial for patients after they leave the hospital, suggesting they help in recovery. Additionally, MTM is being tested as a way to manage type 2 diabetes, with the idea that food can act like medicine. This approach involves healthcare providers prescribing these meals to help manage chronic conditions. Compared to traditional meal services, MTM aims to improve dietary intake and patient satisfaction, which can lead to better health outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Medically Tailored Meals for Healthy Eating?

Research shows that medically tailored meals can help manage chronic conditions and improve dietary intake, especially after hospital discharge. These meals are designed to meet specific nutritional needs, which can enhance patient satisfaction and adherence to dietary guidelines. ^{1 2 3 4 5}

What safety data exists for medically tailored meals?

The available research does not provide specific safety data for medically tailored meals. However, a study on home-delivered meals highlighted issues with food quality, nutrient content, and temperature control, which are important for safety. Another study emphasized the need for verified efficacy and safety data for nutritional products. Overall, while medically tailored meals are recognized as beneficial for managing conditions like type 2 diabetes, specific safety data is not detailed in the provided research. ^{4 5 6 7 8}

Is there any safety data available for medically tailored meals or similar interventions?

The research indicates that home-delivered meals can contribute significantly to nutrition needs, but there were issues with food safety, such as hot foods not meeting temperature guidelines. This suggests that while the meals can be beneficial, attention to food safety standards is important. ^{4 5 6 7 8}

Is the treatment 'Medically Tailored Meals' a promising treatment?

Yes, Medically Tailored Meals are a promising treatment. They provide nutritious, pre-prepared meals that help manage chronic conditions like type 2 diabetes, especially for those with limited access to healthy food. These meals are designed to meet specific health needs and can improve overall nutrition and health outcomes. ^{1 4 5 7 9}

How do medically tailored meals differ from other treatments for type 2 diabetes?

Medically tailored meals are unique because they involve healthcare providers prescribing pre-prepared meals specifically designed to manage or prevent chronic conditions like type 2 diabetes, combined with nutrition education. This approach integrates food as a form of medicine, which is different from traditional treatments that may focus solely on medication or lifestyle advice without providing specific meal plans. ^{1 4 5 7 9}

Research Team

Seth A Berkowitz, MD MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

2. Spain pubmed.ncbi.nlm.nih.gov

[Preferences for the attributes of home enteral nutrition (HEN) in Spain. Do caregivers know their patients' preferences?] [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. 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]

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

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

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

Toward the Definition of Personalized Nutrition: A Proposal by The American Nutrition Association. [2021]

7. England 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. [2020]

8. Italy pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2006]