Implementation of Innovative Food Prescription Programs in Older Adults

NCT06324630 | Completed

• 1 other identifier: 24FIM1266996
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Preferences; Food Habits

Outcome Measures

Primary Outcomes (1)

• Program Redemption

  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. Self-report redemption data will also be compared to point-of-sale and delivery software records.

  Measured weekly for duration of 12-week intervention

Secondary Outcomes (3)

• Program Usage

  Measured weekly for duration of 12-week intervention

• Program Interest by Consenting to Being Contacted/Voiced Interest to Recruiter

  Collected once per eligible individual during approximately 4-week recruitment period

• Program Enrollment

  Collected once per eligible individual during approximately 4-week recruitment period

Other Outcomes (6)

• Fruit and Vegetable Consumption

  Collected at baseline and after 12-week intervention period

• Nutrition Security

  Collected at baseline and after 12-week intervention period

• Self-Efficacy to Purchase, Prepare, and Eat Fresh Fruits and Vegetables

  Collected at baseline and after 12-week intervention period

Study Arms (3)

Produce Prescription Mobile Market

ACTIVE COMPARATOR

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).

Other: Produce Prescription Mobile Market

Produce Prescription Delivery

EXPERIMENTAL

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.

Other: Produce Prescription Delivery

Healthy Meal Kit Delivery

EXPERIMENTAL

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.

Other: Healthy Meal Kit Delivery

Interventions

Produce Prescription Delivery OTHER

Fruit and vegetable box delivery

Produce Prescription Delivery

Healthy Meal Kit Delivery OTHER

Ingredients to cook healthy meals delivered to home

Healthy Meal Kit Delivery

Produce Prescription Mobile Market OTHER

Voucher to purchase fruits and vegetables at a mobile market

Produce Prescription Mobile Market

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 or over
• English-speaking

You may not qualify if:

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

Sponsors & Collaborators

• University at Buffalo: lead
• American Heart Association: collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Food Preferences; Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavior, Animal

Study Officials

• Lucia Leone, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Jill Tirabassi, MPH, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 22, 2024
• Study Start: September 9, 2024
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: July 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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).

Locations

US (1)