An interventional study of Produce Prescription Delivery and Healthy Meal Kit Delivery in Food Preferences and Food Habits, sponsored by University at Buffalo. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University at Buffalo · Not applicable, Interventional, and Prevention
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.
Food insecurity in older adults is a complex issue that is growing in scale. This project will compare two innovative produce prescription delivery models against a usual care produce prescription model. The patient population is older adults (aged 65 and over) who have screened positive for food insecurity from one of three primary care clinics in Erie County Medical Center (ECMC). ECMC is located in a medically underserved area of Buffalo, New York, where the majority of the population identifies as African American. Each participant will be randomized to one of the three study arms. Each intervention will give a participant free food (including 9-11 servings of fruits and vegetables) weekly for 12 weeks. The usual care arm is receiving access to a mobile market-based produce prescription which can be redeemed at over 10 locations in the city. The first intervention arm will have a fully customizable box of fresh fruits and vegetables delivered to their home. The second intervention arm will be a meal kit delivery box where a participant can choose from 6-9 options weekly. Outcomes compared across arms include enrollment, redemption, and food usage. The investigators will also explore impact of the intervention on fruit and vegetable consumption and related psychosocial behaviors. The investigators will collaborate with an older adult patient advisory group in the development of the two novel interventions and utilize rapid weekly survey feedback to optimize the programs before the end of the 12-week time period. This research will help understand how to best address low utilization rates of food prescription programs with the goal of reducing food insecurity and chronic disease among older adults.
155 studies on the registry are indexed under Food Preferences; 20 are open to participants now.
This study's enrollment of 168 is above the median of 133 across 121 interventional studies indexed under Food Preferences.
Browse Food Preferences studies →University at Buffalo is the lead sponsor of 76 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Usual care control is a produce prescription model prescribed by a clinician, providing funds to purchase approx. 9-11 servings of fruit and vegetables per person at designated mobile market provider(s).
Other: Produce Prescription Mobile Market
Intervention arm 1 is a healthy food delivery model, wherein the participant receives a customizable produce box providing approx. 9-11 servings of fruits and vegetables per person.
Other: Produce Prescription Delivery
Intervention arm 2 is a healthy meal kit delivery model providing all ingredients to make 3+ meals with approx. 9-11 servings of fruits and vegetables, with 6-9 meal options to choose from each week.
Other: Healthy Meal Kit Delivery
Fruit and vegetable box delivery
Ingredients to cook healthy meals delivered to home
Voucher to purchase fruits and vegetables at a mobile market
Average Percentage of Prescriptions Redeemed
Redemption will be measured as the weekly usage of the interventions. Participants will receive an automatic notification after each delivery (or weekly for the usual care arm) and will be asked to confirm that they received their delivery/redeemed their prescription. If they do not initially confirm, they will receive two reminder notifications. Redemption will be measured as the percentage of all 12 deliveries/mobile market visits that are either confirmed via post on the usage survey.
Time frame: Average over the 12-week intervention
Average Percentage of Fruit and Vegetables Used
Usage will be measured in the self-reported weekly text surveys that will ask participants approximately what percentage of the fruits and vegetables that they receive was used by someone in their household: all (coded as 100%), most (coded as 75%), about half (coded as 50%), some (coded as 25%) and none (coded as 0%). Answers from all completed surveys over 12 weeks will be averaged to get a percent of food usage for each participant.
Time frame: Measured weekly for duration of 12-week intervention
Eligible Participants Who Were Interested in the Program
Program interest is defined as the percentage of the total eligible individuals that were referred to the program who were 1.) reachable for recruitment and 2.) did not decline participation via either opt-out letter or when contacted by researchers (those who declined prior to being provided detail on their assigned intervention).
Time frame: Collected once per eligible individual during approximately 4-week recruitment period
Percent of Eligible Participants Enrolled
Program enrollment will be measured as the percentage of patients eligible and referred that decide to enroll. Patients who choose not to enroll will be asked to provide more information on why they do not want to enroll.
Time frame: Collected once per eligible individual during approximately 4-week recruitment period
Fruit and Vegetable Consumption
2021 Behavioral Risk Factor Surveillance System Fruit and Vegetable module
Time frame: Collected at baseline and after 12-week intervention period
Nutrition Security
Nutrition Security will be measured using a combination of the United States Department of Agriculture Food Security Survey Module, which assesses accessibility and affordability, with the new suite of nutrition security measures that complement the USDA instrument to help capture the remaining pillars of nutrition security (availability, utilization, and stability)
Time frame: Collected at baseline and after 12-week intervention period
Self-Efficacy to Purchase, Prepare, and Eat Fresh Fruits and Vegetables
10-point Likert scale (strongly disagree to strongly agree, where a positive score indicates a positive belief) using a selection of items adapted from a study of shoppers where self-efficacy was shown to be correlated with nutrition behaviors.
Time frame: Collected at baseline and after 12-week intervention period
Barriers to Eating Fruits and Vegetables
4-point Likert scale (strongly disagree to strongly agree, where a positive score indicates a positive belief) previously tested in lower-income adults which reflects common benefits/barriers found in the literature.
Time frame: Collected at baseline and after 12-week intervention period
Health Status and Disease Risk
Health status and disease risk will be measured using one subscale of the RAND 36-Item Short Form Health Survey (SF-36): 1.) General health: 1 item with a 5-point Likert scale where 1 is excellent and 5 is poor; this is combined with the EQ-5D-5L survey, which consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Time frame: Collected at baseline and after 12-week intervention period
Participants were recruited based on a clinical audit of medical records to identify eligible patients (age 65+) experiencing food insecurity in the prior year (September 2023-Septemebr 2024) and physician referrals from 2 primary care clinics at a regional medical center in Buffalo, NY. The first participant was enrolled on 09/09/2024 and the last participant was enrolled on 10/22/2024.
| Milestone | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery |
|---|---|---|---|
| Started | 22 | 22 | 23 |
| Completed | 16 | 20 | 18 |
| Not completed | 6 | 2 | 5 |
Redemption will be measured as the weekly usage of the interventions. Participants will receive an automatic notification after each delivery (or weekly for the usual care arm) and will be asked to confirm that they received their delivery/redeemed their prescription. If they do not initially confirm, they will receive two reminder notifications. Redemption will be measured as the percentage of all 12 deliveries/mobile market visits that are either confirmed via post on the usage survey.
| percentage of program redeemed | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery |
|---|---|---|---|
| Average Percentage of Prescriptions Redeemed | 28.3 ± 3.4 | 89.2 ± 2.9 | 89.2 ± 2.8 |
Usage will be measured in the self-reported weekly text surveys that will ask participants approximately what percentage of the fruits and vegetables that they receive was used by someone in their household: all (coded as 100%), most (coded as 75%), about half (coded as 50%), some (coded as 25%) and none (coded as 0%). Answers from all completed surveys over 12 weeks will be averaged to get a percent of food usage for each participant.
| percentage of food used | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery |
|---|---|---|---|
| Average Percentage of Fruit and Vegetables Used | 24.9 ± 23.9 | 75.7 ± 26.3 | 77.7 ± 25.7 |
Program interest is defined as the percentage of the total eligible individuals that were referred to the program who were 1.) reachable for recruitment and 2.) did not decline participation via either opt-out letter or when contacted by researchers (those who declined prior to being provided detail on their assigned intervention).
| Participants | All Eligible Individuals Referred to the Study |
|---|---|
| Interested in Program | 67 |
| Not Interested in Program | 101 |
Program enrollment will be measured as the percentage of patients eligible and referred that decide to enroll. Patients who choose not to enroll will be asked to provide more information on why they do not want to enroll.
| percent enrolled | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery |
|---|---|---|---|
| Percent of Eligible Participants Enrolled | 73.3 | 84.6 | 88.5 |
2021 Behavioral Risk Factor Surveillance System Fruit and Vegetable module
Results for this outcome have not been posted.
Nutrition Security will be measured using a combination of the United States Department of Agriculture Food Security Survey Module, which assesses accessibility and affordability, with the new suite of nutrition security measures that complement the USDA instrument to help capture the remaining pillars of nutrition security (availability, utilization, and stability)
Results for this outcome have not been posted.
10-point Likert scale (strongly disagree to strongly agree, where a positive score indicates a positive belief) using a selection of items adapted from a study of shoppers where self-efficacy was shown to be correlated with nutrition behaviors.
Results for this outcome have not been posted.
4-point Likert scale (strongly disagree to strongly agree, where a positive score indicates a positive belief) previously tested in lower-income adults which reflects common benefits/barriers found in the literature.
Results for this outcome have not been posted.
Health status and disease risk will be measured using one subscale of the RAND 36-Item Short Form Health Survey (SF-36): 1.) General health: 1 item with a 5-point Likert scale where 1 is excellent and 5 is poor; this is combined with the EQ-5D-5L survey, which consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Results for this outcome have not been posted.
Collected over From enrollment until the end of follow-up, approximately 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Produce Prescription Mobile Market | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Produce Prescription Delivery | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Healthy Meal Kit Delivery | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 |
| >=65 years | 22 | 22 | 23 | 67 |
| Age, Continuous(years) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| Mean | 70.3 ± 4.1 | 70.1 ± 5.0 | 72.2 ± 6.9 | 70.9 ± 5.5 |
| Sex/Gender, Customized(Participants) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| Female | 12 | 12 | 12 | 36 |
| Male | 10 | 9 | 11 | 30 |
| Missing/Refused | 0 | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 21 | 21 | 23 | 65 |
| Unknown or Not Reported | 0 | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 |
| Black or African American | 16 | 20 | 13 | 49 |
| White | 2 | 2 | 8 | 12 |
| More than one race | 1 | 0 | 1 | 2 |
| Unknown or Not Reported | 2 | 0 | 1 | 3 |
| Region of Enrollment(participants) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| United States | 22 | 22 | 23 | 67 |
| Income(Participants) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| <$10,000 | 6 | 8 | 7 | 21 |
| $10,000 to $19,999 | 3 | 9 | 4 | 16 |
| $20,000 to $29,999 | 2 | 2 | 6 | 10 |
| $30,000 to $39,999 | 3 | 1 | 1 | 5 |
| $40,000 to $49,999 | 2 | 0 | 1 | 3 |
| $50,000 to $59,999 | 2 | 0 | 0 | 2 |
| $60,000 and above | 0 | 1 | 0 | 1 |
| Missing/Refused | 4 | 1 | 4 | 9 |
| Food Security Status(Participants) | Produce Prescription Mobile Market | Produce Prescription Delivery | Healthy Meal Kit Delivery | Total |
|---|---|---|---|---|
| High Food Security | 9 | 7 | 5 | 21 |
| Marginal Food Security | 3 | 4 | 5 | 12 |
| Low Food Security | 6 | 3 | 3 | 12 |
| Very Low Food Security | 4 | 8 | 10 | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All of the individual participant data (including data dictionaries) generated within this study (trial) will be provided to the American Heart Association in a de-identified form, to be deposited within the Health Care x Food data repository on the Precision Medicine Platform, and subject to the Precision Medicine Platform Terms and Conditions. Participant data on the Precision Medicine Platform will be collated with data from other studies that are funded by the American Heart Association Health Care x Food initiative, and used by future investigators for analysis.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be made available in alignment with agreed-upon Open Science Policies at the American Heart Association, whereby any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository as soon as possible, and no later than the time of an associated publication or the end of the award period (and any no-cost extension), whichever come first. Data will be available indefinitely.
Access criteria: Researchers who would like to access the data for the Health Care x Food initiative will be required to create an account on the AHA Precision Medicine Platform and receive approval for their proposed research using the dataset. In addition, de-identified participant data will be made available to anyone who wishes to access the data by sending a request to the study PIs via email (lucialeo@buffalo.edu, jilltira@buffalo.edu).
Ran from Sep 2024 to primary completion in Feb 2025, 5 months.
Results were first posted in Jun 2026, 1 year 3 months after primary completion.
Of 92 non-industry interventional studies with no phase under Food Preferences, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 17. This study's 5 months is close to that.
Counting every sponsor, half of 92 studies reached it within 5 months; a quarter within 1 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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