FIM+DASH: Food is Medicine Intervention to Promote Healthy Eating and Blood Pressure Control
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Illinois at Chicago
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
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
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: FIM Usual Care ArmActive comparator 1 intervention
Group B: FIM Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Systolic and diastolic changes from baseline to 12 weeks and 24 weeks
systolic and diastolic blood pressure
Time frame
Baseline, 12 weeks and 24 weeksSecondary outcomes
1
Weight changes from baseline to 12 weeks and 24 weeks
Change in BMI
Time frame
Baseline, 12 weeks and 24 weeks2
Diet quality changes from baseline to 12 weeks and 24 weeks
Change in DASH score
Time frame
Baseline,12 weeks and 24 weeks3
Waist circumference changes from baseline to 12 weeks and 24 weeks
Change in Waist circumference
Time frame
Baseline,12 weeks and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov