FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
Recruiting · NCT07332741 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Illinois at Chicago
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to treat both hypertension and obesity in adults using a food is medicine framework. Participants will be randomized 1:1 to FIM+DASH or usual-care control. The 24-week trial includes a 12-week FIM+DASH intervention followed by a 12-week maintenance period and leverages existing partnerships with community-based organizations for home food delivery and culinary skill-skill building. The main questions it aims to answer are: (1) What is the effect of FIM+DASH vs. usual care control on blood pressure? (2) What is the effect of FIM+DASH vs. usual care control on DASH diet adherence (diet quality), body weight, and waist circumference? (3) How to identify factors associated with the sustainability and scalability of FIM+DASH in real-world settings?
Who can take part
Inclusion criteria
- Adults aged ≥18 years; diagnosis of hypertension in Electronic health record or most recent clinic blood pressure meeting inclusion thresholds (systolic blood pressure ≥130 mmHg and/or diastolic blood pressure ≥80 mmHg); BMI ≥30 kg/m²; able and willing to complete survey instruments and assessment procedures; able to speak/read English; access to a smartphone with text-messaging capability.
Exclusion criteria
- inability to speak/read English; cognitive impairment that precludes informed consent or participation; severe food allergies or medically necessary dietary restrictions that would preclude adoption of a DASH eating pattern; inability to cook at home; current treatment for cancer; self-reported history of a recent major cardiovascular event within the past 12 months (myocardial infarction, cerebrovascular accident, cardiac surgery, or hypertensive emergency); known advanced liver or renal disease; severe mental illness that would preclude participation; pregnancy. Individuals with lactose intolerance will not be excluded because low-lactose alternatives are available within the intervention.
Where it is running
8 locations listed across 1 US state.
- Mile Square Health Center Chicago - Chicago, Illinois, United States
- Mile Square Health Center - Auburn Gresham - Chicago, Illinois, United States
- Mile Square Health Center - Englewood - Chicago, Illinois, United States
- Mile Square Health Center - South Shore - Chicago, Illinois, United States
- Mile Square Health Center Chicago - Chicago, Illinois, United States
- Mile Square Health Center - Auburn Gresham - Chicago, Illinois, United States
- Mile Square Health Center - Englewood - Chicago, Illinois, United States
- Mile Square Health Center - South Shore - Chicago, Illinois, United States