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: 30

Duration: 4 weeks

46 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Charlene Compher

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 7 or 21 medically tailored meals per week delivered to their homes for four weeks

4 weeks

Weekly meal delivery, telephone visits at day 0, 30, and 60

Crossover Treatment

Participants switch to the alternate meal delivery plan (7 or 21 meals per week) for another four weeks

4 weeks

Weekly meal delivery, telephone visits at day 30 and 60

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+