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FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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?

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
Illinois
Mile Square Health Center - Auburn Gresham
NOT_YET_RECRUITING
Chicago
Mile Square Health Center - Englewood
NOT_YET_RECRUITING
Chicago
Mile Square Health Center - South Shore
RECRUITING
Chicago
Mile Square Health Center Chicago
NOT_YET_RECRUITING
Chicago
Time Frame
Start Date: 2026-05-22
Estimated Completion Date: 2030-09
Participants
Target number of participants: 150
Treatments
Active_comparator: FIM Usual Care Arm
Participants randomized to the usual care arm continue to receive routine clinical care. They do not receive the FIM+DASH intervention during the active intervention period, but they complete study assessments according to the same assessment schedule. If your protocol includes delayed intervention materials/equipment/classes/food support after the primary trial period, include that here.
Experimental: FIM Intervention Arm
Participants randomized to the experimental arm receive the FIM+DASH intervention, which includes Food is Medicine support aligned with DASH dietary guidance. The intervention includes groceries/food support, cooking/nutrition education, behavioral support, self-monitoring tools, and participant follow-up as specified in the protocol.
Related Therapeutic Areas
Sponsors
Leads: University of Illinois at Chicago

This content was sourced from clinicaltrials.gov