Trial Outcomes & Findings for Implementation of Innovative Food Prescription Programs in Older Adults (NCT NCT06324630)

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.

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.

Implementation of Innovative Food Prescription Programs in Older Adults

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.

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.

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).

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.

2021 Behavioral Risk Factor Surveillance System Fruit and Vegetable module

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)

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-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.

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'.