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Implementation of Innovative Food Prescription Programs in Older Adults

Implementation of Innovative Food Prescription Programs in Older Adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06324630
Enrollment
168
Registered
2024-03-22
Start date
2024-09-09
Completion date
2025-02-17
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Habits, Food Preferences

Brief summary

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.

Detailed description

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.

Interventions

OTHERProduce Prescription Delivery

Fruit and vegetable box delivery

OTHERHealthy Meal Kit Delivery

Ingredients to cook healthy meals delivered to home

OTHERProduce Prescription Mobile Market

Voucher to purchase fruits and vegetables at a mobile market

Sponsors

University at Buffalo
Lead SponsorOTHER
American Heart Association
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 65 or over * English-speaking

Exclusion criteria

* Under the age of 65 * Does not speak English * Cognitively impaired (screen for cognitive function)

Design outcomes

Primary

MeasureTime frameDescription
Average Percentage of Prescriptions RedeemedAverage over the 12-week interventionRedemption 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.

Secondary

MeasureTime frameDescription
Average Percentage of Fruit and Vegetables UsedMeasured weekly for duration of 12-week interventionUsage 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.
Eligible Participants Who Were Interested in the ProgramCollected once per eligible individual during approximately 4-week recruitment periodProgram 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).
Percent of Eligible Participants EnrolledCollected once per eligible individual during approximately 4-week recruitment periodProgram 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLucia Leone, PhD

University at Buffalo

PRINCIPAL_INVESTIGATORJill Tirabassi, MPH, MD

University at Buffalo

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
23 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous70.9 years
STANDARD_DEVIATION 5.5
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Food Security Status
High Food Security
7 Participants
Food Security Status
Low Food Security
3 Participants
Food Security Status
Marginal Food Security
12 Participants
Food Security Status
Very Low Food Security
10 Participants
Income
<$10,000
8 Participants
Income
$10,000 to $19,999
9 Participants
Income
$20,000 to $29,999
2 Participants
Income
$30,000 to $39,999
1 Participants
Income
$40,000 to $49,999
0 Participants
Income
$50,000 to $59,999
2 Participants
Income
$60,000 and above
0 Participants
Income
Missing/Refused
9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
20 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
8 Participants
Region of Enrollment
United States
22 participants
Sex/Gender, Customized
Female
12 Participants
Sex/Gender, Customized
Male
9 Participants
Sex/Gender, Customized
Missing/Refused
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 220 / 23
other
Total, other adverse events
0 / 220 / 220 / 23
serious
Total, serious adverse events
0 / 220 / 220 / 23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026