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Enrolling by invitationNCT06999369HF-FITUpdated May 31, 2025

Heart Failure Food Intervention Trial: Impact of a Guideline-based Nutrition Digital Tool in Heart Failure Patient Clinical Outcomes

An interventional study of MedChef App and MedChefs and Instacart food voucher in Heart Failure, sponsored by Sutter Health. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Sutter Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study summary

Measuring the impact of a guideline-based nutrition digital tool in heart failure patients

Read the detailed description

The goal of this research clinical trial is to learn understand or learn whether a guideline-based nutrition application (app) called MedChefs can help heart failure patients adopt and sustain an evidence-based dietary patterns.

02

Conditions studied

  • Heart Failure

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Keywords

  • heart failure
  • nutrition app
  • evidence-based nutrition recommendations
  • guideline-based nutrition app
  • app-based dietary intervention
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 180 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Sutter Health is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-89 years old at time of enrollment
  • Any type of Heart failure diagnosis (e.g., I50.x) between 1/1/2023-present
  • Recent hospital admission (within a year)
  • Race/ethnicity: All race/ethnic groups
  • Location: patients have been treated in the Greater East Bay division and Greater Silicon Valley division areas.
  • Patients with have at least 1 office/outpatient visit with a primary care physician or cardiologist visit before index date

Exclusion criteria

Exclusion Criteria:

    • Patients with certain patient history (cognitive disabilities) and end stage renal or metastatic cancer diagnosis

      • Patients with active drug/substance use. Patients with heart failure who have active substance use are excluded from the study. HF patients with substance use require additional monitoring and follow up due to potential severe withdrawal symptoms, acute HF exacerbation and drug overdose or medication errors. Standard protocol includes additional monitor vital signs (e.g., blood pressure, heart rate) and HF symptoms (e.g., edema, dyspnea), and performing regular laboratory tests (e.g., renal function, electrolytes) which is beyond the clinical and logistical capabilities of this study.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • No intervention
    Control

    Patients 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: MedChefs

    Once 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.

    Other: MedChef App

  • Experimental
    MedChefs plus Instacart Food Voucher

    Once 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.

    Other: MedChef App · Other: MedChefs and Instacart food voucher

Interventions

  • OtherMedChef App

    Once 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.

    Also known as: Nutritional App

  • OtherMedChefs and Instacart food voucher

    Once 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

    Also known as: nutrition app, food voucher

06

What researchers measure

Primary outcomes

  1. Blood Pressure

    Blood pleasure will be measure by mmHg

    Time frame: Baseline and 6 months

Secondary outcomes

  1. Weight

    Weight will be measured in pounds

    Time frame: Baseline and 6 months

07

Study locations

1 site
  • 2121 N. California Blvd., Suite 310
    Walnut Creek, California 94596, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06999369
Lead sponsor
Sutter Health
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Feb 25, 2025
Primary completion
Aug 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 31, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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