Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure

NCT06115369 | Completed

• 1 other identifier: STU-2023-0978
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Heart Failure

Keywords

Heart Failure; Produce; Medically Tailored Meals; Patient Participation

Outcome Measures

Primary Outcomes (1)

• Number of participants with a readmission or emergency department visit for HF

  Total readmissions or visits to the emergency department for HF

  90 days

Secondary Outcomes (5)

• Hierarchical Composite Endpoint

  90 days

• Between group change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score

  The survey will be assessed at baseline and at 90 days at the conclusion of the study.

• Medication adherence

  90 days

• Attendance to scheduled clinic appointments

  90 days

• Filling of outpatient medication prescription

  90 days

Study Arms (3)

Medically Tailored Meals

EXPERIMENTAL

Season Health, our food intervention partner, will provide participants with weekly deliveries of twice daily prepared medically tailored meals (MTM; 14 total per week). Study participants will be able to select choices for these in conjunction with a dietician. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Dietary Supplement: Medically Tailored Meals Delivered Conditionally; Dietary Supplement: Medically Tailored Meals Delivered Unconditionally

Fresh Produce

EXPERIMENTAL

We will work with Season Health, our food intervention partner to provide participants with weekly deliveries of a large box full of fresh produce and pantry staples. The study participants will be able to select choices for these from a large selection of health options in conjunction with a dietician. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Dietary Supplement: Produce Boxes delivered Conditionally; Dietary Supplement: Produce Boxes Delivered Unconditionally

Control arm

NO INTERVENTION

This control arm will receive dietary education only with usual heart failure care.

Interventions

Medically Tailored Meals Delivered Conditionally DIETARY_SUPPLEMENT

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

Medically Tailored Meals Delivered Unconditionally DIETARY_SUPPLEMENT

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.

Medically Tailored Meals

Produce Boxes delivered Conditionally DIETARY_SUPPLEMENT

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.

Fresh Produce

Produce Boxes Delivered Unconditionally DIETARY_SUPPLEMENT

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.

Fresh Produce

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years age with a recent hospitalization for acute decompensated HF

You may not qualify if:

• Baseline hyperkalemia with K \> 5.5 mEq/L or history of hyperkalemia requiring hospitalization for urgent treatment,
• Receipt of a heart transplant or left ventricular assist device,
• Use of inotropic therapy at hospital discharge,
• Discharge to a skilled nursing facility or long-term care facility that provides prepared patient meals, comorbidity with expected survival \< 6 months, and
• Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters).
• Pregnancy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Heart Failure; Patient Participation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ambarish Pandey

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study will be designed as a 2 x 2 factorial randomized clinical trial. First, study patients will be randomized 1:1:1 to receive weekly medically tailored meals (MTM) for twice daily consumption (N = 50) vs. weekly fresh produce box (N = 50) vs. a control arm (usual care with dietary counseling only) (N=50). In the second factorial intervention, participants will be randomized 1:1 to receive their food supplements in a conditional fashion, based on whether they attend clinic visits and fill their medications (N =50) vs. receiving the intervention unconditionally (N =50). The intervention will be initiated within a week of hospital discharge and will continue for a period of 90 days.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 3, 2023
• Study Start: April 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)