Recruiting
Phase 2

FIM+DASH

Sponsor:

University of Illinois at Chicago

Code:

NCT07332741

Conditions

Hypertension

Hypertension (HTN)

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

FIM intervention arm

FIM Usual Care Arm

Study Details

Brief 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?

Conditions

Hypertension

Hypertension (HTN)

Obesity & Overweight

Study ID

NCT07332741

Start date

May 22, 2026

Status verified date

Sep, 2025

Completion date

Sep, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

FIM intervention arm

For 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

FIM 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

Primary outcome measure

  • Systolic and diastolic changes from baseline to 12 weeks and 24 weeks [ Time Frame: Baseline, 12 weeks and 24 weeks ]

Central Contacts and Locations

Locations

Mile Square Health Center - South Shore

Recruiting

Chicago, Illinois, United States, 60649

Contacts

PI

312-355-2125slofto4@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 10, 2026

Last verified

Sep, 2025

Keywords

  • Food is Medicine
  • Hypertension
  • Obesity
  • Nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-10.