Cardiac RehabilitationSUPeRFOODNCT06500962
Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program
A study testing Navigation and Text Messaging in people with Cardiac Rehabilitation and Nutrition, Healthy, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Nutrition, Healthy, Nutrition Poor
- What is being tested?
- Navigation and Text Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 7 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Participating in UCSF Cardiac Rehabilitation
- Able to communicate in English or Spanish
- Resident of San Francisco County
Who cannot join
- Enrolled in hospice
- Unable to consent for self
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
- Conditions
- Cardiac Rehabilitation, Nutrition, Healthy, Nutrition Poor
- Being tested
- Usual Care, Navigation, Text Messaging
- Keywords
- food insecurity, nutrition insecurity, food is medicine
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
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.
NavigationBehavioural
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 MessagingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Not described Receives: Behavioral: Usual Care |
| Navigation + Usual Care | Experimental | Not described Receives: Behavioral: Usual Care; Behavioral: Navigation |
| Text Messaging + Usual Care | Experimental | Not described Receives: Behavioral: Usual Care; Behavioral: Text Messaging |
| Navigation + Text Messaging + Usual Care | Experimental | Not described Receives: Behavioral: Usual Care; Behavioral: Navigation; Behavioral: Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant reported satisfaction
Scale of 1 [Quite dissatisfied] to 5 [Very satisfied]
Measured: 3 months
Secondary outcomes (3)
Number of food is medicine meal or grocery distributions received
Measured: 3 months
Proportion of participants initiating the food is medicine program
Numerator = number of participants who received at least 1 meal or grocery distribution; Denominator = number of participants in study arm
Measured: 3 months
Proportion of participants engaged in the food is medicine program
Numerator = number of participants who received at least 8 meal or grocery distributions; Denominator = number of participants in study arm
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start12 Aug 2024
- Primary completion7 Jan 2026
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 Factorial Randomization
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Project Open Hand
- Responsible party
- Principal investigator, Alexis Beatty, MD, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500962
- Sponsor's protocol ID
- 24FIM1259456
- Acronym
- SUPeRFOOD
- Status last verified
- Feb 2026
- First submitted
- 8 Jul 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset and supporting information will be shared on Dryad.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SUPeRFOOD: Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program
- ClinicalTrials.gov ID
- NCT06500962
- Acronym / sponsor ID
- SUPeRFOOD / 24FIM1259456
- Conditions
- Cardiac Rehabilitation, Nutrition, Healthy, Nutrition Poor
- Keywords
- food insecurity, nutrition insecurity, food is medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Heart Association, Project Open Hand
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 Factorial Randomization
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: Usual Care |
| Navigation + Usual Care | Experimental | Behavioral: Usual Care, Behavioral: Navigation |
| Text Messaging + Usual Care | Experimental | Behavioral: Usual Care, Behavioral: Text Messaging |
| Navigation + Text Messaging + Usual Care | Experimental | Behavioral: Usual Care, Behavioral: Navigation, Behavioral: Text Messaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Participating in UCSF Cardiac Rehabilitation
- Able to communicate in English or Spanish
- Resident of San Francisco County
Key exclusion criteria (2 listed)
- Enrolled in hospice
- Unable to consent for self
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareParticipants will receive a message sent to their electronic health record portal with instructions about how to sign up for a food is medicine program. | Behavioural | Navigation + Text Messaging + Usual Care, Navigation + Usual Care, Text Messaging + Usual Care, Usual Care |
| NavigationParticipants will receive a weekly phone call from a navigator to promote enrollment in the food is medicine program and address any barriers to participation. | Behavioural | Navigation + Text Messaging + Usual Care, Navigation + Usual Care |
| Text MessagingParticipants 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. | Behavioural | Navigation + Text Messaging + Usual Care, Text Messaging + Usual Care |
Primary outcome
Participant reported satisfaction
Time frame: 3 months
Scale of 1 [Quite dissatisfied] to 5 [Very satisfied]
3 secondary outcomes
Number of food is medicine meal or grocery distributions received
Time frame: 3 months
Proportion of participants initiating the food is medicine program
Time frame: 3 months
Proportion of participants engaged in the food is medicine program
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Yes. Dataset and supporting information will be shared on Dryad.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation and Text Messaging in people with Cardiac Rehabilitation and Nutrition, Healthy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant reported satisfaction (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.