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

67 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Implementation of Innovative Food Prescription Programs?

Research shows that food prescription programs can improve access to healthy foods and promote healthier eating habits, especially in under-resourced communities. For example, a pilot program increased fruit and vegetable consumption and improved attitudes toward healthy eating among participants. ^{1 2 3 4 5}

Is the Food Programs for Accessing Healthy Food treatment safe for humans?

There is no specific safety data available for the Food Programs for Accessing Healthy Food treatment, but general safety information on health foods suggests that adverse events can occur, often due to inappropriate use or combining with other products. It's important to use such programs as directed and report any adverse effects to healthcare professionals. ^{6 7 8 9 10}

How does the Food Programs for Accessing Healthy Food treatment differ from other treatments for food insecurity and related health issues?

This treatment is unique because it involves a food prescription program that provides fresh fruits and vegetables along with dietary education to improve access to healthy foods and promote healthier eating habits, especially in food-insecure communities. Unlike traditional treatments that might focus solely on medication or clinical interventions, this approach directly addresses dietary behavior and food access, aiming to reduce food insecurity and improve overall health. ^{1 2 11 12 13}

What is the purpose of this trial?

In the USA, about 10% of grown-ups have a hard time finding healthy food, like fruits and vegetables. It's even harder for older grown-ups who might be sick and find it tricky to move around, which makes it tough to get healthy food. The investigators are trying to fix this by testing two new ways to help older people (aged 65 and up) get nutritious food. The investigators are getting lots of help and ideas from older adults to make these ways work the best they can. The study is happening at the Erie County Medical Center (ECMC) in the East Side of Buffalo, NY, where many African Americans live. This place hasn't been treated fairly, so there aren't many places to buy fresh fruits and vegetables in the local stores. On the ECMC campus, there are three clinics that can help people who can't easily get healthy food. Every participant in our study will be put into one of three programs, each lasting 12 weeks, and they will get food every week. In the "usual care" program, a doctor writes an order, and the participant gets a voucher to buy more fruits and vegetables at a market or store. In the "delivery of a produce prescription box" program, a box of fruits and vegetables is brought to the participant's home. The participant can pick what they like online or by calling a helper. If they don't pick, they get a regular box. In the "delivery of a meal kit box" program, the participant gets the ingredients for three meals in a box. The participant can pick three meals they like online or by calling. If the participant doesn't pick, three meals will be chosen for the participant. For the second and third programs, participants will get messages to remind the participant when to choose their food, when the time to choose is almost up, and when their food is on its way. If a participant can't use messages or the internet, they can call a helper for support. The investigators believe the study will show that these ways can help older adults who have a hard time getting food to eat more fruits and vegetables. The investigators will also find out which way works best compared to the usual way in the Buffalo, NY area.

Research Team

Lucia Leone, PhD

Principal Investigator

University at Buffalo

Jill Tirabassi, MPH, MD

Principal Investigator

University at Buffalo

Eligibility Criteria

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

I am 65 years old or older.

English-speaking

Exclusion Criteria

Cognitively impaired (screen for cognitive function)

I am under 65 years old.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Adoption and implementation of produce prescription programs for under-resourced populations: clinic staff perspectives. [2023]

3. United States 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. [2023]

4. United States 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. [2023]

5. England 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. [2021]

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

An evaluation of spontaneous adverse drug reaction monitoring systems. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Postmarketing surveillance of new food ingredients: design and implementation of the program for the fat replacer olestra. [2016]

8. Japan pubmed.ncbi.nlm.nih.gov

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

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

Adverse drug events: identification and attribution. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. [2018]

11. England pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. [2020]

12. United States 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. [2022]

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

Implementing a Produce Prescription Program in Partnership With a Community Coalition. [2023]