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Healthy Food Provision for Heart Failure (FOOD-HF Trial)

N/A

Recruiting

Led By Ambarish Pandey

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults over 18 years age with a recent hospitalization for acute decompensated HF

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

FOOD-HF Trial Summary

This trial will investigate if providing healthy food can improve outcomes after a hospital stay for heart failure. It will compare giving food vs. money & see if food is more effective when given conditionally.

Who is the study for?

This trial is for adults over 18 who were recently hospitalized for heart failure. They must not have severe potassium issues, a heart transplant, or be on certain heart medications at discharge. People in long-term care facilities, those with short life expectancies, without a stable address, or pregnant women can't join.Check my eligibility

What is being tested?

The study tests if providing medically tailored meals or fresh produce boxes for 90 days after hospital discharge helps patients with heart failure more than just giving financial support. It also looks at whether tying the food supplement to attending follow-up visits or medication adherence makes a difference.See study design

What are the potential side effects?

Since this trial involves food supplementation rather than medication, typical drug side effects are not expected. However, participants may experience changes in their health due to dietary adjustments.

FOOD-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and was recently hospitalized for worsening heart failure.

FOOD-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with a readmission for heart failure or ER visit

Secondary outcome measures

Filling of outpatient medication prescription

Intergroup change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary

Medication adherence

+1 more

FOOD-HF Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Medically Tailored MealsExperimental Treatment2 Interventions

Season Health, our food intervention partner, will provide participants with weekly deliveries of twice daily prepared medically tailored meals (MTM). Study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Group II: Fresh ProduceExperimental Treatment2 Interventions

We will work with Season Health, our food intervention partner to provide participants with weekly deliveries of a large box full of fresh produce and pantry staples. The study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Group III: Control armActive Control1 Intervention

This control arm will receive dietary education only.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,050 Previous Clinical Trials

1,054,209 Total Patients Enrolled

23 Trials studying Heart Failure

13,189 Patients Enrolled for Heart Failure

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,727 Total Patients Enrolled

31 Trials studying Heart Failure

137,629 Patients Enrolled for Heart Failure

Ambarish PandeyPrincipal InvestigatorUT Southwestern

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the age range for participants in this experiment been established, and if so, does it include individuals over thirty?

"This clinical trial is available for patients aged between 18 to 100. Data shows that there are 27 studies represented by individuals below the age of majority, and 764 participants over 65 years old."

Answered by AI

Who is eligible to enroll in this clinical trial?

"To be considered for this trial, an individual must have been diagnosed with heart failure and fall between 18-100 years of age. A total of 150 individuals are needed to make the project a success."

Answered by AI

Are there vacancies available for individuals in this clinical trial?

"Unfortunately, the information posted on clinicaltrials.gov has confirmed that this trial is no longer recruiting candidates as it was last edited on October 31st 2023. However, there are still 777 other medical trials available for those seeking to enroll in a study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure

Ambarish Pandey 2024. "Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06115369.