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This factorial randomized trial compared protective effects on blood pressure of two food insecurity interventions—grocery store subsidies versus home-delivered healthy food boxes—in adults with hypertension. The study found that food subsidies led to moderate and sustained reductions in systolic and diastolic blood pressure at 6 and 18 months. Neither addition of telephone-based lifestyle counseling nor longer intervention duration (12 vs 6 months) significantly improved blood pressure outcomes. Food insecurity scores improved similarly across all groups, suggesting food provision method may influence blood pressure independently.
Study Background
Food insecurity—defined as lacking consistent access to enough nutritious food—is a major social determinant linked to poor cardiovascular outcomes. Its prevalence in populations with hypertension compounds challenges in blood pressure (BP) control, given associated dietary limitations. However, optimal approaches to food insecurity interventions aiming to improve BP remain unclear, particularly regarding the format of food assistance, inclusion of lifestyle counseling, and intervention duration. Clarifying these components is critical to designing scalable, effective programs to reduce hypertension-related morbidity.
Study Design
The Healthy Food First trial was a multi-center, 2 × 2 × 2 factorial comparative effectiveness randomized clinical trial conducted across 364 clinical sites within 2 clinical networks in North Carolina. Participants included 458 adults aged around 50 years, predominantly female (75%), all with hypertension and systolic BP ≥130 mm Hg, who reported food insecurity and spoke English or Spanish. The study tested three intervention elements:
- Food resources: healthy food subsidy redeemable at grocery stores versus biweekly delivered healthy food boxes at home.
- Lifestyle counseling: telephone-based counseling targeting hypertension management or no counseling.
- Duration: 6-month versus 12-month intervention period.
The primary outcome was systolic blood pressure (SBP) at 6 months; secondary outcomes included diastolic blood pressure (DBP) and food security measured at 6, 12, and 18 months.
Key Findings
The study population mean baseline SBP and DBP were 138.2 mm Hg and 87.4 mm Hg, respectively. Participants were racially diverse, with over half identifying as Black and over a third as White.
Food subsidy versus food box: At 6 months, the grocery store food subsidy group had significantly lower SBP (132.8 mm Hg) compared to the food box group (135.3 mm Hg), with a difference of -2.5 mm Hg (95% CI, -4.1 to -0.9, P = .003). DBP was also significantly lower (-1.5 mm Hg difference). These beneficial effects persisted at 18 months for both SBP (-2.1 mm Hg difference) and DBP (-1.6 mm Hg difference), though differences at 12 months were not statistically significant.
Lifestyle counseling: No significant differences in SBP or DBP were observed between groups receiving telephone-based lifestyle counseling versus no counseling at any time points.
Intervention duration: No significant blood pressure differences were found between 6- and 12-month duration groups.
Food security outcomes: Food insecurity scores improved from baseline in all groups but did not differ significantly across intervention arms, indicating that the mode of food provision or counseling duration did not differentially affect self-reported food security.
Expert Commentary
This large pragmatic trial provides valuable insights into structuring food insecurity interventions to improve hypertension management. The modest yet consistent blood pressure reductions with grocery store subsidies likely reflect greater participant autonomy and food variety, which may support better dietary adherence compared to preselected food boxes. The lack of added benefit from telephone-based lifestyle counseling contrasts with previous findings, potentially due to the dominant influence of direct food access in these populations or challenges with remote counseling engagement.
The absence of difference between 6- and 12-month durations suggests that short-term intensive intervention may suffice for blood pressure improvements, important for program cost-effectiveness and scalability. Nonetheless, the overall decline in food insecurity across all groups signifies that both provision methods benefit nutritional security.
Study limitations include the predominantly female cohort and geographic restriction to North Carolina, which could affect generalizability. Future research might explore combinations of tailored food assistance and culturally adapted lifestyle interventions, and potential mechanisms linking food access to cardiovascular health.
Conclusion
The Healthy Food First trial demonstrates that in food-insecure adults with hypertension, grocery store food subsidies can modestly but meaningfully reduce blood pressure compared to home-delivered food boxes. Lifestyle counseling and extending intervention duration beyond 6 months did not enhance these effects. These findings support prioritizing flexible, autonomy-preserving food assistance programs for blood pressure control in food-insecure populations. Interventions focused on improving food access remain essential components of comprehensive hypertension management strategies.
Funding and ClinicalTrials.gov Registration
This study was registered on ClinicalTrials.gov (Identifier: NCT05048836) and funded as detailed in the original publication by Berkowitz et al.
References
Berkowitz SA, Ammerman AS, Knoepp P, et al. Food Insecurity Interventions to Improve Blood Pressure: The Healthy Food First Factorial Randomized Clinical Trial. JAMA Intern Med. 2025 Oct 13:e255287. doi:10.1001/jamainternmed.2025.5287.