Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure

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

Interventions

DIETARY_SUPPLEMENT

Medically Tailored Meals Delivered Conditionally

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.

DIETARY_SUPPLEMENT

Medically Tailored Meals Delivered Unconditionally

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.

DIETARY_SUPPLEMENT

Produce Boxes delivered Conditionally

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.

DIETARY_SUPPLEMENT

Produce Boxes Delivered Unconditionally

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.

Sponsors & Collaborators

• American Heart Association

  collaborator OTHER

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Ambarish Pandey · UT Southwestern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-15

Primary Completion

2025-10-15

Completion

2025-10-30

Countries

• United States

Study Locations