Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Project Open Hand | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Placebo Comparator |
| |
| Navigation + Usual Care | Experimental |
| |
| Text Messaging + Usual Care | Experimental |
| |
| Navigation + Text Messaging + Usual Care | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant reported satisfaction | Scale of 1 [Quite dissatisfied] to 5 [Very satisfied] | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of food is medicine meal or grocery distributions received | 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 |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
Dataset and supporting information will be shared on Dryad.
After publication of primary study results
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 26, 2024 | Feb 3, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
2x2 Factorial Randomization
Not provided
Not provided
Not provided
| 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. |
|
| 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 | 3 months |