Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07332741

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

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?

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypertension Body Weight Cardiovascular Diseases Hypertension (HTN) Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mile Square Health Center - Auburn Gresham, Chicago, Illinois, United States

Loading trial locations.

About this study

FIM+DASH is adapted from the FIM+DASH pilot and informed by prior NIH-funded dietary interventions integrating clinic-community partnerships for culinary skill building and home food delivery. The intervention is designed to strengthen clinic-to-community linkages that support adoption and maintenance of a DASH eating pattern and hypertension (HTN) self-management for weight and BP control. Core components include in-person group and on-demand culinary skill-building, group and on-demand didactic content for DASH adoption and adherence and HTN self-management, brief one-on-one check-ins with a nutrition professional, and weekly DASH-friendly home food delivery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FIM intervention arm

Combination Product

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

Combination Product

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 outcomes

  1. Systolic and diastolic changes from baseline to 12 weeks and 24 weeks

    Time frame: Baseline, 12 weeks and 24 weeks

    systolic and diastolic blood pressure

Secondary outcomes

  1. Weight changes from baseline to 12 weeks and 24 weeks

    Time frame: Baseline, 12 weeks and 24 weeks

    Change in BMI

  2. Diet quality changes from baseline to 12 weeks and 24 weeks

    Time frame: Baseline,12 weeks and 24 weeks

    Change in DASH score

  3. Waist circumference changes from baseline to 12 weeks and 24 weeks

    Time frame: Baseline,12 weeks and 24 weeks

    Change in Waist circumference

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Acronym: FIM+DASH

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 12, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.