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

Phase 2RecruitingNCT07332741

University of Illinois at Chicago150 enrolled

Overview

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?

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

150

Conditions

Hypertension

Interventions

FIM intervention armCOMBINATION_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 ArmCOMBINATION_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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (4)

Mile Square Health Center Chicago

Chicago, Illinois, United States

NOT_YET_RECRUITING

Mile Square Health Center - Auburn Gresham

Chicago, Illinois, United States

NOT_YET_RECRUITING

Mile Square Health Center - Englewood

Chicago, Illinois, United States

NOT_YET_RECRUITING

Mile Square Health Center - South Shore

Chicago, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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

systolic and diastolic blood pressure

Time frame: Baseline, 12 weeks and 24 weeks

Secondary Outcomes

Weight changes from baseline to 12 weeks and 24 weeks

Change in BMI

Time frame: Baseline, 12 weeks and 24 weeks

Diet quality changes from baseline to 12 weeks and 24 weeks

Change in DASH score

Time frame: Baseline,12 weeks and 24 weeks

Waist circumference changes from baseline to 12 weeks and 24 weeks

Change in Waist circumference

Time frame: Baseline,12 weeks and 24 weeks