Heart FailureHF-MTMNCT07251894
Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure
A study testing Medically Tailored Meals in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this interventional pilot study is to evaluate the feasibility, acceptability, and impact of medically tailored meals (MTM) on post-discharge recovery in patients with heart failure for Penn Medicine patients in Philadelphia and Lancaster through two pilots. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Medically Tailored Meals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Have a primary diagnosis of health failure based on ICD code I50* with active hospitalization at time of enrollment
- Must be insured by Medicaid or Medicare or dual eligible
- Ability to read and speak English
- Ability to provide informed consent
Who cannot join
- Are on hospice care or reside in an acute or skilled nursing facility
- Are undergoing evaluation for advanced HF treatments including heart transplant or ventricular assist devices
- Are unable to complete data collection due to cognitive decline or disability (based on the electronic health record or referring provider assessment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HF-MTM Pilot: Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure
The goal of this interventional pilot study is to evaluate the feasibility, acceptability, and impact of medically tailored meals (MTM) on post-discharge recovery in patients with heart failure for Penn Medicine patients in Philadelphia and Lancaster through two pilots.
Read the detailed description
Pilot 1: Will enroll 30 eligible Penn Medicine patients to receive 4 weeks of medically tailored meals (MTMs) directly to their door. Patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 4 week pilot.
Pilot 1 participants will be asked to complete a baseline survey, and end of study survey, and an end of study semi-structured interview.
Pilot 2: Will expand upon the learnings from Pilot 1 and be a larger scale longer Food is Medicine (FIM) intervention with patients receiving 8 weeks of MTM deliveries directly to their door. As with Pilot 1, patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 8 week pilot.
Pilot 2 participants will be asked to complete a baseline survey, a mid-point survey at 4 weeks, and an end of study survey and semi-structured interview.
- Conditions
- Heart Failure
- Being tested
- Medically Tailored Meals
- Keywords
- Medically tailored meals, Food is medicine, Food as medicine, Heart failure, Diet quality, Readmissions
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored MealsOther
Medically tailored meals to provide essential tailored nutrition for patients recovering from a heart failure hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Medically Tailored Meals | Experimental | Participants can choose to receive a weekly delivery of 7, 14, or 21 medically tailored meals at no cost to them for 4 weeks. Receives: Other: Medically Tailored Meals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the MTM intervention
The % of meals successfully delivered to the patient, where a 75% rate of successful delivery indicates feasibility.
Measured: From enrollment to the end of the intervention at 4 weeks for Pilot 1
Acceptability of the MTM intervention as measured by the Net Promoter Score
Will evaluate the acceptability of the intervention among patients through the Net Promoter Score (scale of 0 to 10; 9-10 being promoters, 7-8 being passives, and 0-6 being detractors)
Measured: At the end of the intervention at 4 weeks for Pilot 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251894
- Sponsor's protocol ID
- 859165
- Acronym
- HF-MTM
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HF-MTM Pilot: Pilot Study Exploring the Feasibility, Acceptability, and Impact of Medically Tailored Meals on Post-Discharge Recovery in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07251894
- Acronym / sponsor ID
- HF-MTM / 859165
- Conditions
- Heart Failure
- Keywords
- Medically tailored meals, Food is medicine, Food as medicine, Heart failure, Diet quality, Readmissions
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional pilot study is to evaluate the feasibility, acceptability, and impact of medically tailored meals (MTM) on post-discharge recovery in patients with heart failure for Penn Medicine patients in Philadelphia and Lancaster through two pilots.
Detailed description
Pilot 1: Will enroll 30 eligible Penn Medicine patients to receive 4 weeks of medically tailored meals (MTMs) directly to their door. Patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 4 week pilot.
Pilot 1 participants will be asked to complete a baseline survey, and end of study survey, and an end of study semi-structured interview.
Pilot 2: Will expand upon the learnings from Pilot 1 and be a larger scale longer Food is Medicine (FIM) intervention with patients receiving 8 weeks of MTM deliveries directly to their door. As with Pilot 1, patients will be given the opportunity to choose to receive 7/14/21 meals from the MTM provider for the duration of their participation in the 8 week pilot.
Pilot 2 participants will be asked to complete a baseline survey, a mid-point survey at 4 weeks, and an end of study survey and semi-structured interview.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medically Tailored Meals | Experimental | Other: Medically Tailored MealsParticipants can choose to receive a weekly delivery of 7, 14, or 21 medically tailored meals at no cost to them for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Have a primary diagnosis of health failure based on ICD code I50* with active hospitalization at time of enrollment
- Must be insured by Medicaid or Medicare or dual eligible
- Ability to read and speak English
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Are on hospice care or reside in an acute or skilled nursing facility
- Are undergoing evaluation for advanced HF treatments including heart transplant or ventricular assist devices
- Are unable to complete data collection due to cognitive decline or disability (based on the electronic health record or referring provider assessment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically Tailored MealsMedically tailored meals to provide essential tailored nutrition for patients recovering from a heart failure hospitalization | Other | Medically Tailored Meals |
Primary outcome
Feasibility of the MTM intervention
Time frame: From enrollment to the end of the intervention at 4 weeks for Pilot 1
The % of meals successfully delivered to the patient, where a 75% rate of successful delivery indicates feasibility.
Acceptability of the MTM intervention as measured by the Net Promoter Score
Time frame: At the end of the intervention at 4 weeks for Pilot 1.
Will evaluate the acceptability of the intervention among patients through the Net Promoter Score (scale of 0 to 10; 9-10 being promoters, 7-8 being passives, and 0-6 being detractors)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically Tailored Meals in people with Heart Failure, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the MTM intervention (time frame: From enrollment to the end of the intervention at 4 weeks for Pilot 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.