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Behavioural Intervention

Medically Tailored Meals for Heart Failure and Malnutrition

N/A
Recruiting
Led By Charlene Compher
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Heart Failure (NYHA Class 1-3/ ACC/AHA Stage C) and moderate or severe malnutrition or malnutrition risk
Age ≥ 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Awards & highlights

Study Summary

This trial will compare the effectiveness of 2 meal plans for heart failure patients at risk of malnutrition. It will assess malnutrition risk, readmissions and ED visits.

Who is the study for?
This trial is for adults over 18 with heart failure (NYHA Class 1-3/ACC/AHA Stage C) who are at risk of malnutrition or already malnourished. Participants must live where MANNA delivers meals.Check my eligibility
What is being tested?
The study compares two meal delivery frequencies to see which is better for improving nutrition in heart failure patients: one group will receive seven weekly meals, and the other will get twenty-one. The trial also looks at emergency visits and hospital readmissions.See study design
What are the potential side effects?
Since this trial involves food delivery rather than medication, there aren't typical drug side effects. However, dietary changes could potentially cause digestive discomfort or allergic reactions if new foods are introduced.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have heart failure and am at risk of or currently experiencing moderate to severe malnutrition.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in malnutrition risk
Secondary outcome measures
Emergency Department Visits
Readmissions within 30 days

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 21 medically-tailored meals per weekActive Control1 Intervention
Patients will be randomized to three medically tailored dinner meals each day delivered to their homes for four weeks.
Group II: 7 medically-tailored meals per weekPlacebo Group1 Intervention
Patients will be randomized to medically tailored dinner meals delivered to their homes for four weeks.

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Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,022 Previous Clinical Trials
42,879,300 Total Patients Enrolled
1 Trials studying Malnutrition
Charlene CompherPrincipal InvestigatorUniversity of Pennsylvania
~4 spots leftby Jul 2024
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