Comparative Effectiveness of 7 Versus 21 Home-delivered Medically Tailored Meals to Improve Malnutrition Risk in Malnourished Patients With Heart Failure

NCT06142903 | Completed

• 1 other identifier: 850914
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure; Malnutrition

Keywords

medically-tailored meals; diet quality; readmissions; emergency department visits

Outcome Measures

Primary Outcomes (1)

• change in malnutrition risk

  Malnutrition risk will be measured by the Malnutrition Risk Score survey

  one month

Secondary Outcomes (2)

• Emergency Department Visits

  one month

• Readmissions within 30 days

  one month

Study Arms (2)

7 medically-tailored meals per week

PLACEBO COMPARATOR

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

Other: 7 versus 21 medically tailored meals per week

21 medically-tailored meals per week

ACTIVE COMPARATOR

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

Other: 7 versus 21 medically tailored meals per week

Interventions

7 versus 21 medically tailored meals per week OTHER

Meals designed to support overall cardiovascular health will be provided to patients in their own home setting.

21 medically-tailored meals per week; 7 medically-tailored meals per week

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \>90 years of age
• Dementia/cognitive decline
• Heart Failure stage 4 or D
• Chronic kidney disease stage 5 or dialysis-dependent (GFR\<30 mL/min/1.72 m2)
• Unstable COPD as COPD flare within prior 3 months
• Active cancer therapy
• Pregnancy
• Living in a residential facility such as prison, long-term care, rehabilitation, other
• Allergy to foods on the menus
• Persistent hyperkalemia (\> 5 mEq/L) more than twice without excess potassium intake during hospital admission
• Persistent hypotension (systolic BP\<100 mm Hg) during the hospital admission
• Systolic BP\> 180 or diastolic BP \>100 mmHg
• Active substance or alcohol abuse

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• Compher CW, Quinn R, Haslam R, Bader E, Weaver J, Dudek S, Ritchie MD, Lewis JD, Wu GD. Penn Healthy Diet survey: pilot validation and scoring. Br J Nutr. 2024 Jan 14;131(1):156-162. doi: 10.1017/S0007114523001642. Epub 2023 Jul 31.

  PMID: 37519237 BACKGROUND

• Compher C, Henstenburg JA, Aloupis M, Sun A, Quinn R, Emery E, Thomas J, Crafford AG, Schwartz DR. The nutritional impact of 7 versus 21 home-delivered medically tailored meals in patients with heart failure and malnutrition risk: a random order crossover feeding trial (MEDIMEALS). BMC Nutr. 2025 Mar 18;11(1):56. doi: 10.1186/s40795-025-01036-y.

  PMID: 40102963 DERIVED

MeSH Terms

Conditions

Heart Failure; Malnutrition

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Charlene Compher

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Consented patients will be randomized using a computer-generated scheme in REDcap to delivery of either 7 dinner meals or 21 meals (7 breakfast, 7 lunch, 7 dinner meals) each week for 4 weeks duration. At approximately day 0, 30 and 60 relative to discharge from the hospital, patients will be contacted by telephone to assess their malnutrition risk score, diet quality relative to AHA dietary goals, and obtain their self-measured weight and calf circumference.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 22, 2023
• Study Start: August 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)