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

NCT06500962 — Not applicable, Completed, 84 participants, University of California, San Francisco
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SUPeRFOOD: Enhanced SUPport for Initiation and paRticipation in a FOOD is Medicine Program

RegistryNCT06500962, acronym SUPeRFOOD
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, factorial, masking: triple, supportive care
Enrollment84 (Actual)
SponsorUniversity of California, San Francisco (Other); collaborators: American Heart Association, Project Open Hand
ConditionsCardiac Rehabilitation, Nutrition, Healthy, Nutrition Poor
InterventionsUsual Care, Navigation, Text Messaging (Behavioral)
Datesstart 2024-08-12, primary completion 2026-01-07, completion 2026-01-07, first posted 2024-07-15, last updated 2026-02-05
Locations1 site in United States

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-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. 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.

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+Arms and interventions

ArmTypeInterventionsDescription
Usual CarePlacebo comparatorBehavioral: Usual Care
Navigation + Usual CareExperimentalBehavioral: Usual Care; Behavioral: Navigation
Text Messaging + Usual CareExperimentalBehavioral: Usual Care; Behavioral: Text Messaging
Navigation + Text Messaging + Usual CareExperimentalBehavioral: Usual Care; Behavioral: Navigation; Behavioral: Text Messaging
  • Usual Care (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 (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 (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.

+Outcome measures

Primary outcomes

  • Participant reported satisfaction [3 months]: Scale of 1 \[Quite dissatisfied\] to 5 \[Very satisfied\]

Secondary outcomes

  • Number of food is medicine meal or grocery distributions received [3 months]
  • Proportion of participants initiating the food is medicine program [3 months]: Numerator = number of participants who received at least 1 meal or grocery distribution; Denominator = number of participants in study arm
  • Proportion of participants engaged in the food is medicine program [3 months]: Numerator = number of participants who received at least 8 meal or grocery distributions; Denominator = number of participants in study arm

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
University of California, San FranciscoSan Francisco, CaliforniaUnited States

+Study documents

My Notes