Abstract Body:
Background
Nearly half of all U.S. adults live with hypertension, the most significant modifiable contributor to cardiovascular morbidity and mortality. Food is Medicine (FIM) interventions are emerging strategies that improve access to both fresh produce and clinical nutrition support, yet implementation in underserved populations remains limited.

Hypothesis
We tested whether a FIM intervention would lower systolic blood pressure (SBP) relative to produce bags alone, and whether adherence to DASH (Dietary Approaches to Stop Hypertension) would influence magnitude of treatment response.

Methods
We conducted a 24-week pilot randomized controlled trial among 80 Black and Hispanic adults living with hypertension. Randomized participants were allocated to either THRIVE FIM intervention (produce prescriptions, personalized dietitian counseling, adaptive nutrition messaging) or enhanced usual care (EUC: produce bags alone). BP was measured at study entry, 12, 24 weeks. We calculated DASH scores as a mechanistic mediator. We used mixed-effects models to examine changes within and between groups, tested for treatment effect heterogeneity, stratified by DASH adherence (high ≥4.5 vs. low <4.5) and assessed threshold sensitivity.

Results
Of 80 enrolled participants (mean age 54.5±11.4 years), 40 per group, 62% were Black and 34% were Hispanic. The mean BP was comparable in both groups at baseline (systolic: 136.3 vs. 137.4 mmHg, p=0.772; diastolic: 82.2 vs. 81.2 mmHg, p=0.658, Table 1). By week 24, THRIVE recipients had a SBP reduction of -6.8 mmHg (95% CI: -13.1, -0.5, p=0.035), compared to -0.3 mmHg (95% CI: -6.5, 6.0, p=0.935) in the EUC group. When stratified by DASH adherence (Fig 1), participants with high DASH scores (≥4.5) in the THRIVE group had SBP reduction of -13.3 mmHg (95% CI: -23.3 to -3.2, p=0.010), compared to BP change of +2.0 mmHg (95% CI: -7.8 to 11.9, p=0.685) in the EUC group. Those with low DASH score had BP change of -2.4 mmHg in THRIVE group and -1.1 mmHg in EUC group. Threshold sensitivity testing showed BP-lowering effects across multiple DASH score cutpoints in THRIVE group: -7.4 mmHg at threshold ≥2.0 (p=0.038) to -13.3 mmHg at ≥4.5 (p=0.010), with progressive benefit magnitude at elevated thresholds (Fig 2).


Conclusion
This pilot trial shows that a FIM intervention integrating nutritious food access with individualized dietitian counseling and produce prescription lowers SBP, especially among those who achieve high dietary quality.