NCT06142903Completed
Comparative Effectiveness of 7 Versus 21 Home-delivered Medically Tailored Meals to Improve Malnutrition Risk in Malnourished Patients With Heart Failure
THE COMPARATIVE EFFECTIVENESS OF 7 VERSUS 21 HOME-DELIVERED MEDICALLY TAILORED MEALS TO IMPROVE MALNUTRITION RISK IN MALNOURISHED PATIENTS WITH HEART FAILURE: A RANDOM ORDER CROSSOVER FEEDING TRIAL (MEDIMEALS)
Source: ClinicalTrials.gov · Last updated 20 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 15 Nov 2023
- Start date
- 1 Aug 2022
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- University of Pennsylvania
- Diseases
- Heart failure
- NCT number
- NCT06142903
What you commit to
- Study type: Interventional
- Participants enrolled: 46
- From 1 Aug 2022 to the primary completion date, 1 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable COPD as COPD flare within prior 3 months
Other illness
- Dementia/cognitive decline
- Heart Failure stage 4 or D
- Active cancer therapy
- Allergy to foods on the menus
Lab values
- Chronic kidney disease stage 5 or dialysis-dependent (GFR\<30 mL/min/1.72 m2)
- Persistent hyperkalemia (\> 5 mEq/L) more than twice without excess potassium intake during hospital admission
Age
- \>90 years of age
Other
- Pregnancy
- Living in a residential facility such as prison, long-term care, rehabilitation, other
- Persistent hypotension (systolic BP\<100 mm Hg) during the hospital admission
- Systolic BP\> 180 or diastolic BP \>100 mmHg
- Active substance or alcohol abuse
Who the study is looking for
- Age ≥ 18
- Diagnosis of Heart Failure (NYHA Class 1-3/ ACC/AHA Stage C) and moderate or severe malnutrition or malnutrition risk
- Residence within MANNA delivery area
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.