NutriConnect: Enhancing Health and Food Security through Sustainable Solutions and Partnerships: Design and Protocol of a Pragmatic Comparative Effectiveness Trial

Abstract

Background Food insecurity and poor dietary intake contribute to health disparities, particularly among socioeconomically disadvantaged populations. Produce prescription programs aim to improve access to fruits and vegetables (F&V) for those with diet-sensitive conditions, but comparative effectiveness data are limited.

Objective To compare the impact of two produce prescription strategies, NutriConnect Credit (grocery coupons) and NutriConnect Delivery (home-delivered F&V boxes), on dietary intake, food security, and health outcomes among socioeconomically disadvantaged populations who have been recently hospitalized with diet-sensitive conditions.

Methods In this three-arm pilot trial, recently hospitalized adults with food or financial insecurity and elevated cardiovascular risk were randomized (1:1:1) to Credit, Delivery, or enhanced usual care. The primary outcome is between group difference in change in F&V intake at 6 months. Secondary outcomes include food security and self-reported health-related quality of life. Implementation outcomes are assessed using the PRISM/RE-AIM framework.

Conclusion NutriConnect seeks to provide evidence on the effectiveness and feasibility of two produce prescription strategies to inform scalable “Food is Medicine” programs targeting nutrition-related health disparities.

Trial registration number NCT06263751

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06263751

Funding Statement

This study was funded by the American Heart Association (24FIM1268045)

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Washington University in St. Louis Human Subjects Protection OFfice (Institutional Review Board) approved this research study on 2/20/2024.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Footnotes

Funding: American Heart Association (24FIM1268045)

Disclosures: SGKY was supported by the National Institutes of Health (NIH), grant number T32HL007081 and MDH was supported by K24HL175228. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. MDH has received travel support from the World Heart Federation and consulting fees from PwC Switzerland.

Data Availability

All data produced in the present study will be available upon reasonable request to the authors.

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