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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Produce Prescription Mobile Market | Active Comparator | 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). |
|
| Produce Prescription Delivery | Experimental | 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. |
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| Healthy Meal Kit Delivery | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Produce Prescription Delivery | Other | Fruit and vegetable box delivery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Average over the 12-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fruit and Vegetable Consumption | 2021 Behavioral Risk Factor Surveillance System Fruit and Vegetable module | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucia Leone, PhD | University at Buffalo | Principal Investigator |
| Jill Tirabassi, MPH, MD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States |
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.
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.
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).
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168 eligible individuals were targeted for enrollment. Of 144 individuals contacted via opt-out letter, 3 opted out of being contacted by researchers. An additional 24 individuals were recruited directly via the clinic. Of these 165 participants, 39 were unreachable for recruitment and 26 declined to participate prior to randomization. One individual was paired with a spouse to participate, yielding 101 individuals contacted for enrollment. Of those contacted, 67 were enrolled.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Produce Prescription Mobile Market | 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). Produce Prescription Mobile Market: Voucher to purchase fruits and vegetables at a mobile market |
| FG001 | Produce Prescription Delivery | 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. Produce Prescription Delivery: Fruit and vegetable box delivery |
| FG002 | Healthy Meal Kit Delivery | 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. Healthy Meal Kit Delivery: Ingredients to cook healthy meals delivered to home |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Produce Prescription Mobile Market | 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). Produce Prescription Mobile Market: Voucher to purchase fruits and vegetables at a mobile market |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage of program redeemed | Average over the 12-week intervention |
|
From enrollment until the end of follow-up, approximately 15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Produce Prescription Mobile Market | 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). Produce Prescription Mobile Market: Voucher to purchase fruits and vegetables at a mobile market |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucia Leone | State University of New York at Buffalo | (716) 829-6040 | lucialeo@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2025 | Jan 30, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2025 | Jan 30, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005518 | Food Preferences |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001522 | Behavior, Animal |
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| Healthy Meal Kit Delivery |
| Other |
Ingredients to cook healthy meals delivered to home |
|
| Produce Prescription Mobile Market | Other | Voucher to purchase fruits and vegetables at a mobile market |
|
| 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). | 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. | Collected once per eligible individual during approximately 4-week recruitment period |
| 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. | 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. | 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'. | Collected at baseline and after 12-week intervention period |
| Produce Prescription Delivery |
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. Produce Prescription Delivery: Fruit and vegetable box delivery |
| BG002 | Healthy Meal Kit Delivery | 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. Healthy Meal Kit Delivery: Ingredients to cook healthy meals delivered to home |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Income | Count of Participants | Participants |
|
| Food Security Status | Count of Participants | Participants |
|
| OG001 | Produce Prescription Delivery | 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. Produce Prescription Delivery: Fruit and vegetable box delivery |
| OG002 | Healthy Meal Kit Delivery | 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. Healthy Meal Kit Delivery: Ingredients to cook healthy meals delivered to home |
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of food used | Measured weekly for duration of 12-week intervention |
|
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| Secondary | 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). | Posted | Count of Participants | Participants | Collected once per eligible individual during approximately 4-week recruitment period |
|
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| Secondary | 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. | Analysis was completed on individuals who were eligible and offered the intervention, and includes eligible individuals who decided not to enroll in the study after learning more about the intervention. As such, this analysis population is higher than the number of actual participants who enrolled in the study and were included in the final analysis for all other outcomes. | Posted | Number | percent enrolled | Collected once per eligible individual during approximately 4-week recruitment period |
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| Other Pre-specified | Fruit and Vegetable Consumption | 2021 Behavioral Risk Factor Surveillance System Fruit and Vegetable module | Not Posted | Collected at baseline and after 12-week intervention period | Participants |
| Other Pre-specified | 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) | Not Posted | Collected at baseline and after 12-week intervention period | Participants |
| Other Pre-specified | 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. | Not Posted | Collected at baseline and after 12-week intervention period | Participants |
| Other Pre-specified | 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. | Not Posted | Collected at baseline and after 12-week intervention period | Participants |
| Other Pre-specified | 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'. | Not Posted | Collected at baseline and after 12-week intervention period | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Produce Prescription Delivery | 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. Produce Prescription Delivery: Fruit and vegetable box delivery | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Healthy Meal Kit Delivery | 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. Healthy Meal Kit Delivery: Ingredients to cook healthy meals delivered to home | 0 | 23 | 0 | 23 | 0 | 23 |
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