Food as medicine: a quasi-randomized control trial of two healthy food interventions for chronic disease management among ambulatory patients at an urban academic center

Abstract

Background: Globally, poor nutrition is a driver of many chronic diseases and is responsible for more deaths than any other risk factor. Accordingly, there is growing interest in the direct provision of healthy foods to patients to tackle diet-linked chronic diseases and mortality.

Aim: To assess the effect of two healthy food interventions in conjunction with nutrition counseling and education on select chronic disease markers, food insecurity, diet quality, depression, and on self-efficacy for healthy eating, healthy weight, and chronic disease management.

Methods: This parallel-arm quasi-randomized control trial will be conducted between January 2022 and December 2023. Seventy adult patients recruited from a single academic medical center will be randomly assigned to receive either: i) daily ready-made frozen healthy meals or ii) a weekly produce box and recipes for 15 weeks. Participants will, additionally, take part in one individual nutrition therapy session and watch videos on healthy eating, weight loss, type 2 diabetes, and hypertension. Data on weight, height, glycated hemoglobin, blood pressure, and diabetes and blood pressure medications will be collected in-person at the baseline visit and at 16 weeks from baseline and via medical chart review at six months and 12 months from enrollment. The primary outcome of the study is weight loss at 16 weeks from baseline. Pre- and post-intervention survey data will be analyzed for changes in food insecurity, diet quality, depression, as well as self-efficacy for health eating, healthy weight, and chronic disease management. Through retrospective chart review, patients who received standard of care will be matched to intervention group participants as controls based on body mass index, type 2 diabetes, and/or hypertension.

Findings: By elucidating the healthy food intervention with better health outcomes, this study aims to offer evidence that can guide providers in their recommendations for healthy eating options to patients.

Trial registration: ClinicalTrials.gov NCT05174078.

Keywords: food as medicine; healthy eating; hypertension; medically tailored meals; nutrition counseling and education; obesity; prediabetes; produce programs; type 2 diabetes.

Figure 1.

Flow chart of participant recruitment and completion of study activities.