- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06500962
Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program (SUPeRFOOD)
February 3, 2026 updated by: Alexis Beatty, MD, University of California, San Francisco
SUPeRFOOD: Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Age 18 or older
- Participating in UCSF Cardiac Rehabilitation
- Able to communicate in English or Spanish
- Resident of San Francisco County
Exclusion Criteria
- Enrolled in hospice
- Unable to consent for self
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: 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.
|
|
Experimental: Navigation + 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.
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.
|
|
Experimental: Text Messaging + 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.
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.
|
|
Experimental: Navigation + Text Messaging + 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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant reported satisfaction
Time Frame: 3 months
|
Scale of 1 [Quite dissatisfied] to 5 [Very satisfied]
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of food is medicine meal or grocery distributions received
Time Frame: 3 months
|
3 months
|
|
|
Proportion of participants initiating the food is medicine program
Time Frame: 3 months
|
Numerator = number of participants who received at least 1 meal or grocery distribution; Denominator = number of participants in study arm
|
3 months
|
|
Proportion of participants engaged in the food is medicine program
Time Frame: 3 months
|
Numerator = number of participants who received at least 8 meal or grocery distributions; Denominator = number of participants in study arm
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2024
Primary Completion (Actual)
January 7, 2026
Study Completion (Actual)
January 7, 2026
Study Registration Dates
First Submitted
July 8, 2024
First Submitted That Met QC Criteria
July 8, 2024
First Posted (Actual)
July 15, 2024
Study Record Updates
Last Update Posted (Actual)
February 5, 2026
Last Update Submitted That Met QC Criteria
February 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24FIM1259456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Dataset and supporting information will be shared on Dryad.
IPD Sharing Time Frame
After publication of primary study results
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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