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

Not Applicable

Recruiting

• Conditions: Cardiac Rehabilitation; Nutrition, Healthy; Nutrition Poor
• Interventions: Behavioral: Usual Care; Behavioral: Navigation; Behavioral: Text Messaging

• Registration Number: NCT06500962
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-15
• Status Verified: 2024-08
• Study Start: 2024-08-12
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Navigation + Usual Care	Navigation	-
Text Messaging + Usual Care	Text Messaging	-
Usual Care	Usual Care	-
Navigation + Text Messaging + Usual Care	Usual Care	-
Navigation + Usual Care	Usual Care	-
Text Messaging + Usual Care	Usual Care	-
Navigation + Text Messaging + Usual Care	Navigation	-
Navigation + Text Messaging + Usual Care	Text Messaging	-

Primary Outcome Measures

Name	Time	Method
Participant reported satisfaction	3 months	Scale of 1 \[Quite dissatisfied\] to 5 \[Very satisfied\]

Secondary Outcome Measures

Name	Time	Method
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
Number of food is medicine meal or grocery distributions received	3 months
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States