NCT07011251

Food Insecurity, Food as Medicine, Hypertension

Development of a User Centered Design Approach for Screening, Referral, and Enrollment in Food as Medicine Among Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Alison Gustafson · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. The study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.

Conditions

• Food Insecurity
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Food as Medicine Program	Grocery Prescription - participants will receive a card loaded with $100 per month to be used on the Instacart Fresh Funds program website/app or a SodaHealth grocery prescription card to be used inside a Kroger or Food City stores. Patients who select grocery delivery where Instacart is not available will receive Food City meals for the same value. or 2) Medically Tailored Meals (MTM) - participants receive approximately 5 frozen meals per week from Mom's Meals that follow an approved diet for those with hypertension. Participants will complete screening questions (screening decision tree attached) after informed consent to determine which food package the participant will receive. The screening decision tree is a tool that asks about kitchen availability for preparing foods, skills, and access to transportation. Depending on how the patient answers they will receive either grocery prescription or MTM for 3-months or 12-weeks.
OTHER	Survey	Participants answering "no" to assistance but agreeing to the 20-30 minute survey will receive a direct link to a survey related to reasons for not wanting assistance to answer questions at one time point.

Timeline

• Start date: 2024-08-16
• Primary completion: 2025-01-29
• Completion: 2025-01-29
• First posted: 2025-06-08
• Last updated: 2026-04-01
• Results posted: 2026-04-01

Locations

1 site across 1 country: United States