Medically Tailored Meals for Heart Failure and Malnutrition

Overseen By Amy Sun, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Heart failure stage 4, CKD stage 5, others

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This protocol is designed to compare the effectiveness of two dietary intervention doses for patients with heart failure (HF) and malnutrition risk or malnutrition at hospital discharge. This random order crossover design will provide evidence as to whether the provision of dinner meals alone versus all 3 daily meals to patients' homes is more effective at improving malnutrition risk score, and secondarily unplanned emergency department visits and readmissions.

Research Team

Charlene Compher

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

You live in the area where MANNA delivers.

I have heart failure and am at risk of or currently experiencing moderate to severe malnutrition.

I am 18 years old or older.

Treatment Details

Interventions

• Medically Tailored Meals

Trial Overview 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.

Participant Groups

Group I: 21 medically-tailored meals per week Active Control 1 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 week Placebo Group 1 Intervention

Patients will be randomized to medically tailored dinner meals delivered to their homes for four weeks.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+