Food Programs for Accessing Healthy Food

Overseen By Jill Tirabassi, MPH, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University at Buffalo

Disqualifiers: Under 65, Non-English, Cognitive impairment

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help older adults access healthy food, focusing on fresh fruits and vegetables. Researchers are testing three food programs, known as the Implementation of Innovative Food Prescription Programs, to determine which is most effective for those struggling to obtain nutritious food. Participants will either receive vouchers to buy produce, have a box of fruits and vegetables delivered, or get meal kits with ingredients for three meals. Older adults aged 65 and over who speak English and have difficulty accessing healthy food might be suitable for this study. The goal is to identify which program helps participants increase their fruit and vegetable intake in the Buffalo, NY area. As an unphased trial, this study offers participants the opportunity to contribute to innovative solutions for improving access to healthy food.

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 seems focused on food access, so it's unlikely to require changes to your medication.

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

Research has shown that programs providing weekly deliveries of fruits and vegetables are generally safe and well-liked. One study found that participants were very satisfied with the produce boxes they received, even consuming unfamiliar fruits and vegetables without issues. These programs have been linked to health benefits such as weight loss and increased fruit and vegetable intake, with no major safety concerns reported.

For meal kit delivery services, safety primarily depends on how the food is packaged and kept cool during delivery. Proper packaging and maintaining the right temperature are crucial to preventing spoilage. While risks exist if these steps aren't followed, most meal kits remain safe when these guidelines are met.

Overall, both produce and meal kit delivery programs aim to provide healthy food options with a focus on safety. Participants have responded positively to these programs, which offer a convenient way to access nutritious foods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these innovative food prescription programs because they aim to directly address accessibility and nutrition in underserved communities. The Produce Prescription Mobile Market allows individuals to use prescriptions to access fresh produce at mobile markets, making healthy food more accessible. The Produce Prescription Delivery takes it a step further by delivering customizable boxes of fruits and vegetables directly to participants' homes. Meanwhile, the Healthy Meal Kit Delivery provides all the ingredients needed for several meals each week, offering both convenience and variety. Unlike traditional methods that may only provide food vouchers or limited access, these approaches offer targeted, actionable solutions to improve dietary habits and overall health.

What evidence suggests that this trial's programs could be effective in helping older adults access healthy food?

Research has shown that programs providing prescriptions for fruits and vegetables can improve dietary habits and increase consumption of these foods. In this trial, participants may join the Produce Prescription Mobile Market arm, which provides funds to purchase fruits and vegetables at designated mobile markets. Alternatively, participants might join the Produce Prescription Delivery arm, receiving a customizable produce box, or the Healthy Meal Kit Delivery arm, receiving meal kits with ingredients for multiple meals. These programs may also enhance heart health and aid in diabetes management. For those using meal kit delivery services, studies suggest they can promote healthier eating habits and reduce food waste. Participants often find meal kits enjoyable and notice positive changes in their eating patterns. Both methods aim to make accessing healthy food easier, especially for older adults. ^{1 6 7 8 9}

Who Is on the Research Team?

Jill Tirabassi, MPH, MD

Principal Investigator

University at Buffalo

Lucia Leone, PhD

Principal Investigator

University at Buffalo

Are You a Good Fit for This Trial?

This trial is for English-speaking older adults aged 65 or above who struggle to access healthy foods. It's designed to help those in the East Side of Buffalo, NY, particularly where fresh produce is scarce.

Inclusion Criteria

English-speaking

I am 65 years old or older.

Exclusion Criteria

Cognitively impaired (screen for cognitive function)

I am under 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Intervention

Participants are randomized into one of three programs, each lasting 12 weeks, receiving weekly food deliveries or vouchers.

12 weeks

Weekly interactions (virtual or in-person)

Follow-up

Participants are monitored for changes in nutrition security, quality of life, and program usage after the intervention.

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Implementation of Innovative Food Prescription Programs

Trial Overview The study tests three methods: usual care with vouchers for market produce, home delivery of a customizable box of fruits and vegetables, and delivery of meal kits with ingredients for three meals. Each participant will experience one method over 12 weeks.

How Is the Trial Designed?

Group I: Produce Prescription Delivery Experimental Treatment 1 Intervention

Intervention arm 1 is a healthy food delivery model, wherein the participant receives a customizable produce box providing 21 servings of fruits and vegetables per person.

Group II: Healthy Meal Kit Delivery Experimental Treatment 1 Intervention

Intervention arm 2 is a healthy meal kit delivery model providing all ingredients to make 3+ meals with 21 servings of fruits and vegetables, with 6-9 meal options to choose from each week.

Group III: Produce Prescription Mobile Market Active Control 1 Intervention

Usual care control is a produce prescription model prescribed by a clinician, providing funds to purchase 21 servings of fruit and vegetables per person at designated mobile market provider(s).

Who Is Running the Clinical Trial?

University at Buffalo

Lead Sponsor

Trials

139

Recruited

105,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

In a survey of 3,000 consumers, 17% reported experiencing adverse events from health food use, but only 11% of these cases were reported to public health centers, highlighting a significant gap in reporting.

Physicians and pharmacists often do not report adverse events due to health foods because they struggle to establish a clear cause-and-effect relationship, indicating a need for better education on the importance of reporting such incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. Chiba, T., Kobayashi, E., Sato, Y., et al.[2018]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

Patients with diabetes expressed frustration over inconsistent dietary advice from healthcare providers and a lack of culturally relevant recommendations, highlighting the need for tailored nutrition guidance.

Registered dietitian nutritionists (RDNs) identified a need for more training in cultural humility and culinary nutrition skills to effectively support low-income, diverse populations in implementing food prescription and culinary medicine programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators of Implementing a Clinic-Integrated Food Prescription Plus Culinary Medicine Program in a Low-Income Food Insecure Population: A Qualitative Study. McWhorter, JW., Danho, MP., LaRue, DM., et al.[2022]

In a pilot study involving 172 participants from food-insecure areas, a collaborative food prescription program led to a remarkable 94.1% decrease in food insecurity, highlighting its effectiveness in improving access to nutritious food.

Participants received an average of 29.2 pounds of fresh produce and reported high satisfaction with the program, indicating strong community support and the potential for positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. Aiyer, JN., Raber, M., Bello, RS., et al.[2020]

Produce prescription programs can effectively improve diet quality and address diet-related chronic diseases, as clinic staff noted the tangible benefits for patients as a key factor for adoption.

Successful implementation of these programs requires flexibility in clinic workflows, but challenges such as increased staff time and skepticism about sustainability remain significant barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption and implementation of produce prescription programs for under-resourced populations: clinic staff perspectives. Folta, SC., Li, Z., Cash, SB., et al.[2023]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

The Fruit and Vegetable Prescription (FVRx) program, tested with 54 SNAP-eligible adults over 6 months, successfully retained 77.3% of participants, who utilized nearly 90% of their produce prescriptions, indicating strong engagement and feasibility.

Participants in the FVRx program significantly increased their intake of fruits and vegetables, improved their knowledge of food preparation, and changed their food purchasing habits compared to a control group, demonstrating the program's effectiveness in enhancing nutrition-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. Slagel, N., Newman, T., Sanville, L., et al.[2023]

A comprehensive postmarketing surveillance (PMS) system was successfully implemented for olestra (Olean), a noncaloric fat substitute, which involved collaboration with snack manufacturers and utilized specialized skills from Consumer Relations and Medical Affairs.

The PMS system effectively managed consumer reports and included a clinical studies program and an independent medical advisory panel, confirming the safety of olestra in savory snacks and providing timely data to the FDA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of new food ingredients: design and implementation of the program for the fat replacer olestra. Slough, CL., Miday, RK., Zorich, NL., et al.[2016]

Produce Prescription Programs (PPPs) effectively improve dietary intake of fruits and vegetables among food-insecure populations by connecting patients to community resources, demonstrating a successful intervention model.

The Pontiac Prescription for Health pilot program highlights the importance of participatory planning and collaboration with community partners, emphasizing that thorough preparation and engagement can significantly enhance the implementation and success of such health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Produce Prescription Program in Partnership With a Community Coalition. Stevenson, LD., Lucarelli, J., Stewart, SA., et al.[2023]

The FDA's adverse drug reaction reporting system is designed to identify rare and unexpected reactions to medications, but the data collected is voluntary and spontaneous, leading to potential biases.

Using this spontaneous reporting data to calculate actual adverse reaction rates or to compare the safety of different drugs is inappropriate, as it does not accurately reflect the true incidence of these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of spontaneous adverse drug reaction monitoring systems. Sachs, RM., Bortnichak, EA.[2013]

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

The increasing use of health foods for disease prevention has raised concerns about potential risks, as many consumers are unaware of the adverse effects that can arise from inappropriate use, such as combining multiple health foods or mixing them with medications.

To address these safety concerns, the Health Foods Network (HFNet) was created as an online database to provide healthcare professionals with evidence-based information on the safety and effectiveness of health foods, aiming to improve patient consultations and promote safe usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information System on the Safety and Effectiveness of Health Foods and Recent Topics]. Chiba, T.[2019]

A pilot program prescribing fresh fruits and vegetables to 60 food-insecure patients led to significant improvements in food security and increased consumption of fruits and certain vegetables, indicating a positive impact on dietary habits.

Participants reported enhanced availability and accessibility of healthy foods, suggesting that fresh food prescription programs can effectively support healthier eating and improve food environments for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. Heasley, C., Clayton, B., Muileboom, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11006563/

Satisfaction with a meal kit delivery program and feasibility ... The primary purpose of this phase I randomized, crossover trial was to assess the safety, acceptability, and satisfaction of a meal kit delivery program.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11990246/

New Dietary Trends—Meal Kit Delivery Services as a ... People using meal kits declare that having switched to that type of diet has enabled them to significantly reduce their food waste [17,18,19].

3. eatwellmealkits.com eatwellmealkits.com/impact-and-data/

Impact and Data - EatWell EatWell's impact report uses data on food access, behavior change, and cost-effectiveness, aiming to improve health and reduce costs, aligning with UN goals.

4. jneb.org jneb.org/article/S1499-4046(23)00577-8/abstract

Participant Insights From a Family-based Meal Kit Delivery ... Postintervention, most participants reported positive changes in eating patterns and mindset changes enabling future healthier eating. The ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0195666321007236

Meal kits in the family setting: Impacts on family dynamics ... Meal kits reduce women's mental load, enhance family participation, provide nutritionally dense meals, and reduce food eaten away-from-home.

6. ncceh.ca ncceh.ca/resources/evidence-briefs/out-box-food-safety-considerations-meal-kits

“Out of the box” food safety considerations for meal kits This blog discusses the food safety implications of meal kits and provides information that can be communicated to manufacturers and consumers of meal kits.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39177537/

Home Delivery Meal Kits Online Food Safety-Related ... Identified gaps in information and inadequate delivery protocols potentially increase the risk of offering unsafe food to consumers. Suggestions ...

8. food-safety.com food-safety.com/articles/8323-reducing-food-safety-risks-in-meal-kits

Reducing Food Safety Risks in Meal Kits Proper packaging and transportation and delivery protocols are critical to ensuring that a safe temperature is maintained and that the ...

9. multibriefs.com multibriefs.com/briefs/sneb/latestonmealkits2.pdf

The latest on meal kits (revised with updated food safety ... You can find many articles with anecdotes about the pros and cons of meal kits but little hard data. Most of the concerns about the meals have focused on excess ...