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

NCT06999369 | Enrolling By Invitation

• 2 other identifiers: 2024.112EXP382101125-0525
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

heart failure; nutrition app; evidence-based nutrition recommendations; guideline-based nutrition app; app-based dietary intervention

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Blood pleasure will be measure by mmHg

  Baseline and 6 months

Secondary Outcomes (1)

• Weight

  Baseline and 6 months

Study Arms (3)

Control

NO INTERVENTION

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.

Intervention: MedChefs

EXPERIMENTAL

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

MedChefs plus Instacart Food Voucher

EXPERIMENTAL

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

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.

Also known as: Nutritional App

Intervention: MedChefs; MedChefs plus Instacart Food Voucher

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

Also known as: nutrition app, food voucher

MedChefs plus Instacart Food Voucher

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sutter Health: lead

Study Sites (1)

2121 N. California Blvd., Suite 310

Walnut Creek, California, 94596, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 31, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)