FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
Part of paid clinical trials in Chicago, Illinois.
- Sponsor
- University of Illinois at Chicago
- Study ID
- NCT07332741
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Hypertension
- Hypertension (HTN)
- Obesity & Overweight
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- FIM intervention arm — COMBINATION_PRODUCTFor weeks 1-12: Culinary skill-building: 8 In-person and remote sessions will teach participants core techniques (knife skills, batch cooking, sodium-aware seasoning, whole-grain preparation, vegetable-forward entrées, low fat dairy use, lean-protein methods). DASH-friendly home food delivery. Participants will receive 12 weekly deliveries that provide items consistent with DASH (e.g., fruits/vegetables, low-fat dairy \[lactose-free available\], whole grains, lean proteins) dietary regimen. Participants will receive one-on-one support sessions with the interventionist to reinforce DASH adoption/adherence and HTN self-management tasks. For weeks 13-24, self-monitoring of BP and weight twice monthly continues via the text platform.
- FIM Usual Care Arm — COMBINATION_PRODUCTFIM Usual care arm (control) receives usual clinical care during the 24-week period, with limited study contact outside scheduled data-collection visits; after completing all study visits, control participants receive the post-study materials
Study Details
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?
Key Dates
- Start date
- Mar 1, 2026
- Status verified
- Sep 2025
- Primary completion
- Mar 31, 2029
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: FIM Usual Care Arm
- Experimental: FIM Intervention Arm
Primary Outcome Measure
blood pressure [ Time Frame: From enrollment to the end of treatment at 12 weeks, then at 24 weeks (maintenance phase) ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Miles Square Health Center - Auburn Gresham | Chicago | Illinois | 60620 | |
| Miles Square Health Center - Englewood | Chicago | Illinois | 60621 | |
| Miles Square Health Center - South Shore | Chicago | Illinois | 60649 | Claire Thesing, MD (SUB_INVESTIGATOR) |
| Miles Square Health Center Chicago | Chicago | Illinois | 60608 |
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