Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes
Part of paid clinical trials in Walnut Creek, California.
- Sponsor
- Sutter Health
- Study ID
- NCT06999369
- Status
- Enrolling By Invitation
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 89 Years
- Healthy Volunteers
- Not accepted
Interventions
- MedChef App — OTHEROnce patients have been randomized to the MedChefs arm, they will be contacted by the research team and sent an email link to use the MedChefs app. The research team will contact the patient based on their preferred contact method and will walk through how to use the app and share education on its use.
- MedChefs and Instacart food voucher — OTHEROnce patients have been randomized to the MedChefs arm and voucher arm, they will be contacted by the research team and sent an email link to use the MedChefs app. The research team will contact the patient based on their preferred contact method and will walk through how to use the app and share education on its use and use of Instacart food vouchers. Patients will also be given a $100 voucher to buy food recommended by the app. Vouchers will be provided once a month for the 6 months of the study
Study Details
Measuring the impact of a guideline-based nutrition digital tool in heart failure patients
Key Dates
- Start date
- Feb 25, 2025
- Status verified
- May 2025
- Primary completion
- Aug 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 180 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: ControlPatients in the control arm will be asked to complete a baseline survey questionnaire and a final survey questionnaire 6 months after they enroll. During enrollment or (if not obtained at baseline) up to 1 month after, patients will be asked to provide their baseline BP and weight measurements. Study team members will contact patients at month 3 and 6 to ask how they are doing and get follow up BP and weight measurements.
- Experimental: Intervention: MedChefsOnce patients have been randomized to the MedChefs arm, they will be contacted by the research team and sent an email link to use the MedChefs app During enrollment or up to 1 month after, patients will be contacted to provide their baseline BP and weight measurements. Patients will be contacted at month 3 and 6 by the research team to see how they are doing, about their app use, get their BP and weight measurements and will be sent a final survey 6 months after they first log into MedChefs.
- Experimental: MedChefs plus Instacart Food VoucherOnce patients have been randomized to the MedChefs arm and voucher arm, they will be contacted by the research team and sent an email link to use the MedChefs app. Patients will also be given a $100 voucher to buy food recommended by the app. Vouchers will be provided once a month for the 6 months of the study. During enrollment or up to 1 month after, patients will be asked to provide their baseline BP and weight measurements. At month 3 and 6 the research team will contact the patients to see how they are doing and ask for patients follow up BP and weight measurements. Patients will also be asked to complete a final survey 6 months after they first log into MedChefs.
Primary Outcome Measure
Blood Pressure [ Time Frame: Baseline and 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| 2121 N. California Blvd., Suite 310 | Walnut Creek | California | 94596 | - |
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