Trial Summary
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.
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.
12345Is 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.
678910How 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.
12111213Eligibility 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)
Does not speak English
I am under 65 years old.
Trial 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)
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Produce Prescription DeliveryExperimental Treatment1 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 DeliveryExperimental Treatment1 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 MarketActive Control1 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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University at BuffaloBuffalo, NY
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Who Is Running the Clinical Trial?
University at BuffaloLead Sponsor
References
Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. [2021]Estimates place low intake of fruits and vegetables, physical inactivity, and high BMI (overweight-obesity) as all in the top 12 causes of death. Food and dietary education are becoming a focus in how we approach disease prevention and management, and food prescription programs in particular are showing promise, especially in under-resourced, food-insecure communities. This paper describes a pilot food prescription program in a handful of uninsured patients enrolled in an interprofessional clinical and educational program of a medical school in South Florida. This case series of four patients struggling with food insecurity profiles the demographic and clinical characteristics of the participants and provides the results of standardized assessments of their dietary behaviors, physical activity levels, and attitudes toward food before and after the intervention. This four-month pilot food prescription program, Fresh Start Food Rx, involved a prospective case report of four patients seen on a mobile health center (MHC) for uninsured patients in South Miami, Florida. The MHC is part of an interprofessional health professions education, health care, and social service program of the Herbert Wertheim College of Medicine at Florida International University called the Neighborhood Health Education Learning Program (NeighborhoodHELP). A systematic review of South Miami MHC patient electronic medical records identified eligible participants for the program: patients with food insecurity and a BMI >30, with comorbid health conditions. Patients with greater BMI and more comorbidities were prioritized. Once enrolled, we provided biweekly packages of fresh fruits and vegetables along with monthly dietary education to the participants. Key measures included self-reported fruit and vegetable consumption, attitude toward healthy eating, and level of activity. Pre- and post-intervention focus groups assessed barriers the participants faced to eating healthy and pursuing physical activity, satisfaction with the program, feedback on strengths and weaknesses, and anticipated behavioral changes after completion of the program. Prior to the intervention, participants reported eating fruits on an average of 4.5 days out of the week. Post-survey answers increased to 5.0 days per week. Though the average amount of days per week that participants reported eating vegetables decreased slightly, the average number of vegetable servings that participants reported eating in a week increased. At termination of the program, most participants agreed that a diet rich in fruits and vegetables is good for you, that it is important to eat fruits and vegetables every day, and that a diet rich in fruits and vegetables can protect against cancer. This case study demonstrates that easier access to healthy foods, such as fresh produce delivery, and regular health education have the potential to promote healthier attitudes toward foods like fruits and vegetables. This change in attitude can then influence behavior, such as choosing to try new produce or increasing the amount and frequency of produce consumption. With the lessons learned from this small pilot program, the authors helped facilitate the expansion of a larger food prescription program in conjunction with a community partner hospital in the area. Findings from this experience might prove useful for others attempting to develop or expand a food prescription and health education program of their own.
Adoption and implementation of produce prescription programs for under-resourced populations: clinic staff perspectives. [2023]Produce prescription programs represent a promising intervention strategy in the healthcare setting to address disparities in diet quality and diet-related chronic disease. The objective of this study was to understand adoption and implementation factors related to these programs that are common across contexts and those that are context-specific.
A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. [2023]Fruit and Vegetable Prescription (FVRx) programs rely on diverse community and clinic partnerships to improve food security and fruit and vegetable consumption among medically underserved patient populations. Despite the growth in these programs, little is known about the feasibility or effectiveness of the unique partnerships developed to implement FVRx programs conducted in both community and free safety-net clinic settings. A 6-month nonrandomized controlled trial of an FVRx program was pilot tested with 54 Supplemental Nutrition Assistance Program (SNAP)-eligible adults with diet-related chronic conditions. The intervention combined monthly produce prescriptions for local produce at a farmers market, SNAP-Ed direct nutrition education, and health screenings for low-income adults. Process and outcome evaluations were conducted with respective samples using administrative program data (recruitment, retention, and prescription redemption) and self-administered pre- and postintervention surveys with validated measures on dietary intake, nutrition knowledge and behavior, and food purchasing practices. Descriptive statistical analyses were conducted. The FVRx program retained 77.3% of participants who spent nearly 90% of their prescription dollars. After the intervention, the FVRx group reported significantly increased total intake of fruits and vegetables, knowledge of fresh fruit and vegetable preparation, purchase of fresh fruits and vegetables from a farmers market, and significantly altered food purchasing practices compared with the control group. Community-based nutrition education organizations enhance the feasibility and effectiveness of community and clinic-based FVRx programs for improving low-income adults' ability to enhance food and nutrition-related behaviors.
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]Food provision interventions (eg, produce/food prescriptions, food pharmacies, food voucher programs) that bridge clinic and community settings for improved nutritional health outcomes of at-risk patients have gained momentum. Little is known about the role of nutrition education and potential augmented impact on patient outcomes.
"I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. [2021]Food insecurity is associated with poor nutritional health outcomes. Prescribing fresh fruits and vegetables in healthcare settings may be an opportunity to link patients with community supports to promote healthy diets and improve food security. This mixed methods study evaluated the impacts of a fresh food prescription pilot program.
An evaluation of spontaneous adverse drug reaction monitoring systems. [2013]The Food and Drug Administration maintains an adverse drug reaction reporting system. Physicians report suspected adverse reactions that occur while a patient is taking a drug; reporting is voluntary and spontaneous. Data from spontaneous adverse drug reaction reporting systems are designed to signal that rare, unsuspected adverse reactions exist as a result of using a specific drug. Problems arise when attempts are made to use such data for other purposes. Specifically, spontaneous adverse drug reaction data, such as those published by the Food and Drug Administration, are inappropriate for calculating actual adverse drug reaction rates for specific drugs or for making safety comparisons among drugs. This is because these data are subject to numerous biases that can be easily identified and described but not easily corrected. As a result, data from spontaneous adverse drug reaction reporting systems bear little relationship to the actual incidence of adverse drug reactions.
Postmarketing surveillance of new food ingredients: design and implementation of the program for the fat replacer olestra. [2016]Following U.S. Food and Drug Administration (FDA) approval for the use of olestra, a noncaloric fat substitute (brand name Olean) in food snacks, the manufacturer agreed to provide safety updates on market experience to the FDA. However, guidelines for food product postmarketing surveillance (PMS) are not available and those typically used with medical products were only partly applicable. In modeling the Olean program, we drew from experience with consumer products and incorporated elements typical of medical product PMS. A cooperative effort was established with Olean snack manufacturers and a two-tiered, multidisciplinary approach enlisting Consumer Relations and Medical Affairs personnel was used to maximize use of specialized skills. The result of this effort was implementation of a reliable PMS system which could handle a high volume of reports from consumers while providing pertinent data required for medical interpretation of these reports. Summaries of data for the Olean snack manufacturers and FDA were generated in timely fashion. In addition to collection of the spontaneous reports from consumers, a clinical studies program was undertaken and an independent medical advisory panel was established. Through these, we gained perspective on the spontaneous reports and additional confirmation of the safety of olestra in savory snacks.
[Information System on the Safety and Effectiveness of Health Foods and Recent Topics]. [2019]Along with an increase in self-care and self-medication practices, the use of health foods as primary and secondary methods of disease prevention has increased. Consumers are aware only of the health benefits of dietary ingredients, although the potential risks associated with most ingredients are unknown. Adverse events associated with the use of health foods have been reported, and in some cases they were due to inappropriate use such as the concomitant use of several health foods or health foods and drugs. It is important that healthcare professionals, especially pharmacists, provide reliable, evidence-based information to ensure the safe and appropriate use of dietary supplements by their patients. Thus, we constructed an online database, the "Health Foods Network (HFNet)" that compiles reports on the safety and effectiveness of health foods and their ingredients. It serves to disseminate information based on scientific research not only in Japan but also worldwide. This article provides an overview of the HFNet. Additionally, findings from our recent survey and educational interventions among college students are discussed. We hope that this article will be helpful for pharmacists and other healthcare professionals who provide consultations on the use of health foods.
Adverse drug events: identification and attribution. [2022]The definition of an adverse drug event should be tailored to one's purpose in examining the incident. Although the more specific of these definitions is required for scientific evaluation of the link between drug and event, other less stringent definitions are usually adequate for clinical purposes. Knowledge about the safety profile of a drug in humans is limited at the time of marketing. The mechanisms for supplementing safety data during postmarketing include (1) the Spontaneous Reporting System maintained by the Food and Drug Administration, (2) formal projects to assemble safety data on larger or more complex populations, and (3) formal projects designed to answer specific research questions. Judgments about attribution can be no better than the data that support them. The criteria applied by the clinician to the individual adverse drug experience to determine association differ from those required to establish causation based on epidemiologic evidence. In most situations, regulatory action on drug recall should be based on epidemiologic evidence. This article will discuss the choice of a definition for an adverse drug event, examine the extent and nature of the safety data assembled on a drug at the time it is marketed, propose the best methods for collecting additional information after marketing, and designate factors to be considered in judging a drug to be causally related to an adverse event.
Behaviors in Response to Adverse Events Associated with Health Food Use: Internet Survey of Consumers, Physicians and Pharmacists. [2018]Adverse events associated with health food use appear to be quite common. Nevertheless, even though severe adverse events should be reported to the Japanese government via public health centers, the number of cases reported is relatively small. To clarify this discrepancy and to understand how consumers and physicians act when they or their patients develop adverse events due to health food use, we conducted an internet questionnaire with consumers (preliminary survey: n=44,649; full survey: n=3,000), physicians (n=500), and pharmacists (n=500). During 2016, 17% of consumers who used health foods developed adverse events. However, only 11% of them reported their adverse events to public health centers. Most physicians and pharmacists did not report these cases to public health centers because they were unable to establish a clear cause-and-effect relationship. It is important to encourage not only consumers, but also physicians and pharmacists to report adverse events to public health centers.
A pilot food prescription program promotes produce intake and decreases food insecurity. [2020]Food insecurity is associated with limited food resources that may lead to poor nutritional intake and diet-related chronic disease. Food prescription programs offer an avenue for facilitating access to fresh and healthy nonperishable food while reducing food insecurity. The purpose of this pilot study is to examine the feasibility, perceptions, and impact of a collaborative food prescription program in an area with a high rate of food insecurity. The study was a single group pre-post evaluation design. Participants were recruited from two school-based clinics and one Federally Qualified Health Center in north Pasadena, an area with a high rate of food insecurity in Harris County, TX. Adult, food insecure participants were screened at health clinics for eligibility. Participants received nutrition education materials and 30 pounds of a variety of fresh produce plus four healthy, nonperishable food items every 2 weeks for up to 12 visits at a local food pantry. Surveys and tracking tools monitored food insecurity, program dosage, reach, fidelity, acceptability, and program costs. Surveys and key informant interviews assessed perceptions of health care providers, implementation staff, and participants. Participants (n = 172) in the program reported a 94.1% decrease in the prevalence of food insecurity (p
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]Food prescription and culinary medicine programs are gaining popularity as tools for decreasing food insecurity, increasing personal agency, promoting healthy eating, and reducing the risk of chronic diseases. However, there is a gap in understanding of how health care professionals can deliver evidence-based how-to nutrition information that is tailored for culturally diverse, low-income populations.
Implementing a Produce Prescription Program in Partnership With a Community Coalition. [2023]Healthy eating reduces risk for chronic disease, but can be out of reach for many Americans experiencing food insecurity. Produce Prescription Programs (PPPs) have emerged as an intervention to address barriers related to fruit and vegetable consumption. Using a social prescribing model, PPPs connect patients with referrals to community resources to reduce barriers to healthy eating. There is evidence of success of PPPs at improving dietary intake, yet little discussion within the literature of practical aspects of implementation. As interest grows around establishing PPPs within communities, increased attention to strategic planning and implementation remains necessary to develop robust and effective programming. We describe implementing the Pontiac Prescription for Health pilot program, highlighting the participatory planning process with partners. Development and implementation included a program model, recruitment methods and materials, a voucher contract and tracking system with produce vendors, physical activity opportunities, culturally competent health education sessions, and evaluation tools. We offer insight into lessons learned and practical implications for future "on-the-ground" planning and implementation. Engaging in a rigorous participatory planning process with all community partners, allowing adequate time to establish service agreements and a voucher system with vendors, and engaging program participants in different ways and spaces throughout the community can enhance program success.