Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure

NCT ID: NCT06115369

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-10-30

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?

Detailed Description

Eating a nutritious diet is important for maintaining health. However, getting healthy foods can be a challenge for many individuals whose food shopping is limited by finances, location, or physical limitations from pre-existing health problems. For such in-need individuals, providing supplemental healthy meals can improve their diet and potentially improve their health outcomes. Additionally, getting food supplements can also be a powerful incentive to encourage healthy behaviors.

Individuals with heart failure (HF) present a unique population to assess the value of food supplementation both for its nutritional value and as a health engagement incentive. HF is a common, high-cost public health problem in the United States. Hospitalizations for HF are associated with high rates of mortality, readmission, worsened quality of life, and burgeoning healthcare expenditures. During the post-discharge period, patients are exceptionally vulnerable to a wide variety of adverse health events due to multi-system physiologic impairments. Roughly 20% of all patients with Medicare are readmitted within 30 days, and many are readmitted for different causes than the principal diagnosis of the index admission. While multifactorial, frequent contributing causes of HF readmission include dietary indiscretion, failure to take medications, and failure to follow up with healthcare providers.

Prior studies demonstrate that patients with HF often have food insecurity and non-ideal diets. Nationally, food insecurity among those patients with cardiovascular diseases has increased. Those with HF specifically had some of the highest rates of food insecurity, and the prevalence of food insecurity rose from 11.3% in 1999-2000 to 45.3% in 2017-2018.

Studies have also investigated whether providing food supplements to patients with HF can potentially also improve health outcomes. In a recent cohort study, Medicare Advantage patients with acute heart failure (HF) were given up to 4 weeks of post-hospitalization home-delivered meals. Compared with historical controls, those receiving these meals were significantly less likely to have all-cause readmission and death. In contrast, a recent randomized clinical trial found that providing 10 weeks of medically tailored meals to patients with chronic diseases hospitalized during the COVID-19 pandemic did not lead to reductions in risk of 90-day readmission. However, in an exploratory sub-analysis, patients with HF who had the medically tailored meal intervention had significant reductions in readmissions. While these data are supportive of the hypothesis, they are not definitive, and a prospective randomized trial among patients with HF is needed to rigorously support the efficacy of food support in the post-discharge period to reduce readmission. There is also limited information on the type and means of food supplementation may affect its efficacy.

Based on this background, 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 used that will simultaneously investigate two separate important food-related questions. The first factorial design question will evaluate the direct impact of two nutritional supplementation strategies on rehospitalizations and ED visits for HF. Specifically, those hospitalized for HF will be randomized at hospital discharge to either 90 days of healthy medically tailored full meals (MTM) (n=50) or 90 days of a weekly fresh produce box (n=50) or to a control arm (usual care receiving no food supplements with dietary education only) (N=50).

The second factorial intervention will determine whether food supplements can be used as an incentive to increase patient engagement in their own care (i.e., attending a follow-up clinic visit and filling their prescriptions). Specifically, participants receiving food supplementation will be randomized 1:1 to receive their food supplements (MTMs or produce box) in an unconditional or conditional fashion based on the participant successfully attending their clinic visits and filling their medication.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Medically Tailored Meals

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.

Group Type: EXPERIMENTAL

Medically Tailored Meals Delivered Conditionally

Intervention Type: 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 Delivered Unconditionally

Intervention Type: 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.

Fresh Produce

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.

Group Type: EXPERIMENTAL

Produce Boxes delivered Conditionally

Intervention Type: 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.

Produce Boxes Delivered Unconditionally

Intervention Type: 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.

Control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ambarish Pandey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ambarish Pandey

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2023-0978

Identifier Type: -

Identifier Source: org_study_id