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Completed

NCT Number: NCT06324630

Implementation of Innovative Food Prescription Programs in Older Adults

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.

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Key information

Conditions

Food Preferences Behavior Behavior, Animal Feeding Behavior Food Habits

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Produce Prescription Delivery

Other

Fruit and vegetable box delivery

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

Primary outcomes

  1. Average Percentage of Prescriptions Redeemed

    Time frame: Average over the 12-week intervention

    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.

Secondary outcomes

  1. Average Percentage of Fruit and Vegetables Used

    Time frame: Measured weekly for duration of 12-week intervention

    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.

  2. Eligible Participants Who Were Interested in the Program

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

    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).

  3. Percent of Eligible Participants Enrolled

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

    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.

Other outcomes

  1. Fruit and Vegetable Consumption

    Time frame: Collected at baseline and after 12-week intervention period

    2021 Behavioral Risk Factor Surveillance System Fruit and Vegetable module

  2. Nutrition Security

    Time frame: Collected at baseline and after 12-week intervention period

    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)

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

    Time frame: Collected at baseline and after 12-week intervention period

    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.

  4. Barriers to Eating Fruits and Vegetables

    Time frame: Collected at baseline and after 12-week intervention period

    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.

  5. Health Status and Disease Risk

    Time frame: Collected at baseline and after 12-week intervention period

    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'.

Sponsors and collaborators

Lead sponsor

University at Buffalo

Other

Collaborators

  • American Heart Association

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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