NCT06500962

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

August 12, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

July 8, 2024

Last Update Submit

February 3, 2026

Conditions

Cardiac RehabilitationNutrition, HealthyNutrition Poor

Keywords

food insecuritynutrition insecurityfood is medicine

Outcome Measures

Primary Outcomes (1)

  • Participant reported satisfaction

    Scale of 1 \[Quite dissatisfied\] to 5 \[Very satisfied\]

    3 months

Secondary Outcomes (3)

  • Number of food is medicine meal or grocery distributions received

    3 months

  • Proportion of participants initiating the food is medicine program

    3 months

  • Proportion of participants engaged in the food is medicine program

    3 months

Study Arms (4)

Usual Care

PLACEBO COMPARATOR
Behavioral: Usual Care

Navigation + Usual Care

EXPERIMENTAL
Behavioral: Usual CareBehavioral: Navigation

Text Messaging + Usual Care

EXPERIMENTAL
Behavioral: Usual CareBehavioral: Text Messaging

Navigation + Text Messaging + Usual Care

EXPERIMENTAL
Behavioral: Usual CareBehavioral: NavigationBehavioral: Text Messaging

Interventions

Usual CareBEHAVIORAL

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 + Text Messaging + Usual CareNavigation + Usual CareText Messaging + Usual CareUsual Care
NavigationBEHAVIORAL

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.

Navigation + Text Messaging + Usual CareNavigation + Usual Care
Text MessagingBEHAVIORAL

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 CareText Messaging + Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Participating in UCSF Cardiac Rehabilitation
  • Able to communicate in English or Spanish
  • Resident of San Francisco County

You may not qualify if:

  • Enrolled in hospice
  • Unable to consent for self

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: 2x2 Factorial Randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 15, 2024

Study Start

August 12, 2024

Primary Completion

January 7, 2026

Study Completion

January 7, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Dataset and supporting information will be shared on Dryad.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After publication of primary study results

Locations

US(1)