Adherence Patterns in a Randomized Controlled Trial of a Client-Choice Pantry-Based Food is Medicine Program.

BACKGROUND

Food is Medicine (FIM) interventions, including medically tailored groceries (MTG), are increasingly being investigated as an approach to improving chronic disease management in populations with lower income. To deliver on the potential benefits of FIM for ameliorating disparities in chronic disease outcomes, interventions need to be effective, pragmatic and desirable to patients.

OBJECTIVES

We sought to examine socio-economic and demographic correlates of enrollment, retention, adherence, and participation. Additionally, we assessed how the nutritional quality of food selected at a client choice food pantry varied across the duration of the study and by study arm.

METHODS

We implemented a 3-arm pilot randomized controlled trial (RCT) including 3 groups: usual pantry services, MTG only, and MTG + food resource coaching. Chi-squared tests, t-tests and ANOVA were used to compare participants versus eligible non-participants, completers versus those who did not, and among participants across study arms. Differences in the nutritional quality of foods selected between each study group were assessed using multiple variable regression models.

RESULTS

Among 586 individuals screened, 330 completed the screener and met eligibility criteria; 210 (64% of eligible participants) enrolled. Individuals meeting inclusion criteria whose preferred language was Spanish were more likely to enroll in the study (60% of Spanish speakers enrolled versus 44% of English speakers, p=0.004). Among 210 participants, there were no statistically significant differences in characteristics between completers (81.4%) versus non-completers (18.6%). Over 4 months, food selections for all groups became more nutritious.

CONCLUSION

This FIM intervention achieved a high level of enrollment, retention, adherence, and participation among safety-net healthcare system patients that typically experience a high burden of chronic disease and poorer chronic disease outcomes.

TRIAL REGISTRATION: The randomized controlled trial from which the cost estimates are reported is registered at ClinicalTrials.gov, ID number NCT06242808: https://clinicaltrials.gov/study/NCT06242808. Registration date: 02/05/2024.