Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program

NCT ID: NCT06500962

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2026-01-07

Brief Summary

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The purpose of this research is to see if offering more navigation and text-message support will help increase participation and engagement in a Food is Medicine program. The study will recruit people currently participating in cardiac rehabilitation. People will be randomly assigned to 1 of 4 study groups: navigation, text-messaging, both, or neither. People will complete surveys at the start of the study and after 3 months. After 3 months, we will compare how many Food is Medicine meals or groceries people in each group received.

Detailed Description

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Conditions

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Cardiac Rehabilitation Nutrition, Healthy Nutrition Poor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 Factorial Randomization
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Usual Care

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants will receive a message sent to their electronic health record portal with instructions about how to sign up for a food is medicine program.

Navigation + Usual Care

Group Type EXPERIMENTAL

Usual Care

Intervention Type BEHAVIORAL

Participants will receive a message sent to their electronic health record portal with instructions about how to sign up for a food is medicine program.

Navigation

Intervention Type BEHAVIORAL

Participants will receive a weekly phone call from a navigator to promote enrollment in the food is medicine program and address any barriers to participation.

Text Messaging + Usual Care

Group Type EXPERIMENTAL

Usual Care

Intervention Type BEHAVIORAL

Participants will receive a message sent to their electronic health record portal with instructions about how to sign up for a food is medicine program.

Text Messaging

Intervention Type BEHAVIORAL

Participants will receive two text messages per week to promote healthy eating, enrolling in a food is medicine program, and continuing to participate in a food is medicine program.

Navigation + Text Messaging + Usual Care

Group Type EXPERIMENTAL

Usual Care

Intervention Type BEHAVIORAL

Participants will receive a message sent to their electronic health record portal with instructions about how to sign up for a food is medicine program.

Navigation

Intervention Type BEHAVIORAL

Participants will receive a weekly phone call from a navigator to promote enrollment in the food is medicine program and address any barriers to participation.

Text Messaging

Intervention Type BEHAVIORAL

Participants will receive two text messages per week to promote healthy eating, enrolling in a food is medicine program, and continuing to participate in a food is medicine program.

Interventions

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Usual Care

Participants will receive a message sent to their electronic health record portal with instructions about how to sign up for a food is medicine program.

Intervention Type BEHAVIORAL

Navigation

Participants will receive a weekly phone call from a navigator to promote enrollment in the food is medicine program and address any barriers to participation.

Intervention Type BEHAVIORAL

Text Messaging

Participants will receive two text messages per week to promote healthy eating, enrolling in a food is medicine program, and continuing to participate in a food is medicine program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age 18 or older
2. Participating in UCSF Cardiac Rehabilitation
3. Able to communicate in English or Spanish
4. Resident of San Francisco County

Exclusion Criteria

1. Enrolled in hospice
2. Unable to consent for self
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Project Open Hand

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Alexis Beatty, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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24FIM1259456

Identifier Type: -

Identifier Source: org_study_id

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