CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Medically Tailored Meals Delivered Conditionally +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06115369
NCT06115369N/ACompleted

Examining the Impact of Medically Tailored Meals vs Produce Supplements Delivered Conditionally vs Not on Health Engagement and Health Outcomes Among Patients With Heart Failure

University of Texas Southwestern Medical Center·interventional·Posted Nov 3, 2023·Updated Nov 18, 2025

In Brief

A clinical study evaluating Medically Tailored Meals Delivered Conditionally, Medically Tailored Meals Delivered Unconditionally, and 2 other interventions for Heart Failure. Completed, enrolled 150 participants across 1 site.

Detailed Summary

The current study proposes to investigate if the provision of healthy food can improve outcomes following discharge after HF hospitalization. To investigate this in an efficient and pragmatic manner, a factorial randomized control trial design will be utilized to simultaneously investigate two separate, important food-related questions: * Does the provision of 90 days of either medically-tailored meals or fresh produce boxes improve 90-day patient outcomes among those with HF relative to a control group not receiving food supplements and instead receiving an equivalent monetary supplement? * Does receipt of the supplement in a conditional fashion, where the supplement is continued only if the participant attends follow-up visits or fills prescribed medications at the pharmacy, have more impact than providing unconditional supplementation?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States

Timeline

N/ACompletedFinished
202420252026
First PostedNov 3, 2023
Enrollment StartApr 15, 2024
Primary CompletionOct 15, 2025
Study CompletionOct 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 2.7 years ago

Interventions

Medically Tailored Meals Delivered Conditionallydietary

Season Health, our food intervention partner, will provide participants with weekly deliveries of twice-daily prepared medically tailored meals (MTM). Participants will receive this supplement conditioned on continued participation and engagement in their healthcare, including attending all scheduled office visits and refilling prescription medications. If participants do not refill their prescriptions or do not attend their office visits, the shipments of medically tailored meals will be paused. These will be restarted when the participant's appointment is rescheduled or when the participant's prescription is refilled.

Medically Tailored Meals Delivered Unconditionallydietary

Season Health, our food intervention partner, will provide participants with weekly deliveries of twice-daily prepared medically tailored meals (MTM). Participants will receive this supplement unconditionally for the entire study duration.

Produce Boxes delivered Conditionallydietary

Season Health, our food intervention partner, will provide participants with weekly deliveries of fresh produce and pantry staples. Participants will receive this supplement conditioned on continued participation and engagement in their healthcare, including attending scheduled office visits and refilling prescription medications. If participants do not refill their prescriptions or do not attend their office visits, the shipments of medically tailored meals will be paused. These will be restarted when the participant's appointment is rescheduled or when the participant's prescription is refilled.

Produce Boxes Delivered Unconditionallydietary

Season Health, our food intervention partner, will provide participants with weekly deliveries of fresh produce and pantry staples. Participants will receive this supplement unconditionally throughout the entire study period.