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Enrolling by Invitation

NCT Number: NCT06999369

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

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

Enrolling by Invitation

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2121 N. California Blvd., Suite 310

Walnut Creek, California, 94596, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • • 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.

Treatment and study plan

MedChef App

Other

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.

Other names: Nutritional App

MedChefs and Instacart food voucher

Other

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

Other names: nutrition app, food voucher

Primary outcomes

  1. Blood Pressure

    Time frame: Baseline and 6 months

    Blood pleasure will be measure by mmHg

Secondary outcomes

  1. Weight

    Time frame: Baseline and 6 months

    Weight will be measured in pounds

Sponsors and collaborators

Lead sponsor

Sutter Health

Other

Registry information

Official study title

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

Acronym: HF-FIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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