- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07031739
Food Assistance and Blood Pressure Control Study for Adults with Hypertension
This important clinical trial focuses on helping adults with uncontrolled hypertension (high blood pressure) who also struggle with food insecurity. The study aims to find the best ways to improve blood pressure control through different food assistance programs while also helping participants stick to their recommended diets and medications.
Nearly half of American adults have high blood pressure, which is a major cause of heart disease, kidney problems, and other serious health conditions. While medications help, doctors also strongly recommend following the DASH diet (Dietary Approaches to Stop Hypertension) - which emphasizes fruits, vegetables, and whole grains while reducing salt and unhealthy fats. However, many people can't follow this diet because they don't have consistent access to healthy food (food insecurity).
The study will test three different approaches to help with food insecurity:
- Providing information about community food resources
- Pairing participants with a Community Health Worker who will provide ongoing support
- Delivering specially prepared meals designed for heart health directly to participants' homes
Over 200 participants will be randomly assigned to different combinations of these approaches over 9 months. The researchers will track blood pressure changes, how well participants follow their diet and medications, food security status, and overall quality of life.
What makes this study unique is that it adapts the help based on participants' needs. If someone's blood pressure doesn't improve enough after 3 months with the initial approach, they'll be offered additional support. This mimics real-life situations where people may need different levels of assistance at different times.
For families dealing with high blood pressure and food insecurity, this research could lead to better support programs that truly meet people's needs. The study may show which types of food assistance work best for whom, helping doctors and communities design more effective programs. It also recognizes that managing chronic conditions like high blood pressure isn't just about medications - it's about addressing life challenges like food access that make treatment difficult.
High blood pressure affects millions of Americans, especially in communities with limited resources. Research like this is crucial because it looks at practical solutions that combine medical care with real-world support. By helping people overcome food insecurity, we may be able to improve not just blood pressure numbers, but overall health and quality of life. This study could provide valuable information for healthcare systems, insurers, and policymakers about how to invest in food assistance programs that actually improve health outcomes.
The results may help shape future programs that combine medical care with nutrition support, potentially reducing health disparities in communities most affected by both food insecurity and high blood pressure. For patients and caregivers, this research offers hope that more comprehensive approaches to chronic disease management are being developed - approaches that understand and address the everyday challenges people face in staying healthy.
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