Trial results for a study evaluating interventions to address food insecurity in patients with Hypertension were posted on ClinicalTrials.gov on 2025-08-05. The lowest mean systolic blood pressure observed was 136.8 mmHg in the Resource Referral + Medically Tailored Meals (MTM) intervention group.
Background
Hypertension affects a significant portion of the adult population in the US, with 47% of adults diagnosed with the condition. It is a major risk factor for cardiovascular disease (CVD) and accounts for more CVD deaths than any other risk factor. Food insecurity is a critical issue within this vulnerable population, highlighting the need for adaptive, stepped-care interventions to improve health outcomes.
Trial design
This completed study, titled "Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)", enrolled 60 participants with Hypertension. The trial had no specified phase. It explored various intervention approaches, including resource referral, community health worker (CHW) intervention, and medically tailored meals (MTM), in different combinations to address food insecurity.
Key results
The trial results included several key measurements related to blood pressure and study feasibility:
- Systolic Blood Pressure Readings (mmHg):
- Resource Referral Only: Mean 144.3 (Standard Deviation 8.2)
- Resource Referral + Community Health Worker (CHW) Intervention: Mean 138.1 (Standard Deviation 9.1)
- Resource Referral + Medically Tailored Meals (MTM): Mean 136.8 (Standard Deviation 12.6)
- Community Health Worker (CHW) Only: Mean 151.7 (Standard Deviation 18.2)
- Community Health Worker (CHW) + CHW Assistance: Mean 150.8 (Standard Deviation 22.0)
- Community Health Worker (CHW) Assistance + Medically Tailored Meals: Mean 146.4 (Standard Deviation 16.1)
- Diastolic Blood Pressure Readings (mmHg):
- Resource Referral Only: Mean 87.4 (Standard Deviation 8.9)
- Resource Referral + Community Health Worker (CHW) Intervention: Mean 81.6 (Standard Deviation 8.1)
- Resource Referral + Medically Tailored Meals (MTM): Mean 89.8 (Standard Deviation 12.5)
- Feasibility of Recruitment Percentage:
- Proportion of Patients Who Consented to be Part of the Study: 0.98
- Feasibility of Retention (Proportion of participants):
- Resource Referral: 0.5
- Community Health Worker (CHW) Intervention: 0.625
What this means
The posted results suggest that interventions addressing food insecurity, particularly those incorporating medically tailored meals, may contribute to lower systolic blood pressure in patients with hypertension. The mean systolic blood pressure was lowest in the group receiving both resource referral and medically tailored meals, at 136.8 mmHg. While recruitment feasibility was high, with 0.98 of patients consenting, retention rates varied across different intervention arms, ranging from 0.5 to 0.625. These findings indicate the potential benefit of comprehensive support, including nutritional interventions, for managing hypertension in food-insecure populations, while also highlighting areas for improving participant retention in such programs.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05800145, titled "Trial to Address Food Insecurity in Patients With Hypertension (SMART-FI)", were posted on 2025-08-05 on clinicaltrials.gov.