Medically Tailored Grocery Deliveries to Improve Food Security and Hypertension in Underserved Groups: A Student-Run Pilot Randomized Controlled Trial.

BACKGROUND/

objectivesRandomized controlled trials (RCTs) are needed to evaluate the impact of food is medicine (FIM) programs, such as medically tailored groceries (MTGs) to treat hypertension among diverse populations. Partnerships between academic centers' student-run organizations (SROs) and community-based organizations (CBOs) offer critical safety nets for historically underserved groups, positioning these organizations to effectively undertake FIM programs among populations disproportionately affected by hypertension. We conducted an unblinded pilot RCT whose objectives were to assess the feasibility and acceptability of an SRO-coordinated, CBO-partnered MTGs intervention targeting blood pressure (BP) and food insecurity (FI) in underserved groups.

methodsAdult Black/African American and Hispanic/Latinx patients in Durham, North Carolina, where essential hypertension and FI were randomized (parallel arm, computerized 1:1 ratio) to 12 weeks of home-delivered, hypertension-focused MTGs plus in-person nutrition education sessions with compensation (intervention) versus data collection sessions with compensation (control). We offered transportation, childcare, and home visits to facilitate session attendance. The primary outcomes were the eligibility, enrollment, and retention rates (feasibility), and the survey feedback from the participants and CBO partners (acceptability). The secondary outcomes included the changes in the mean BP and median FI score with associated 95% confidence intervals.

resultsMedical record screening identified 1577 eligible participants. Of the 94 reached to confirm eligibility, 77 met the enrollment criteria, and 50 were randomized (82% post-screen eligibility, 65% enrollment). A conventional content analysis of 15 participant surveys and CBO partner feedback affirmed the acceptability, noting intervention components that enhanced the retention (e.g., home delivery, transportation support, home visits). Pre-post analyses of secondary outcomes for 13/25 intervention and 15/25 control participants completing ≥2 sessions ≥2 months apart were performed. The intervention was associated with an average change in systolic BP of -14.2 mmHg (-27.5, -4.5) versus -3.5 mmHg (-11.7, 5.9) in the control group. The FI scores improved by -2 (-2.2, -0.5) in the intervention group and -1 (-1.3, -0.2) in the control group. No adverse events were reported.

conclusionsSRO-CBO partnerships could be feasible and acceptable avenues for conducting FIM trials among underserved populations. This multi-component FIM approach enhanced the study equity by addressing the participants' disease-related social needs and warrants expansion into a powered RCT.