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

Conditions

• Hypertension
• Hypertension (HTN)
• Obesity & Overweight

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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?

Key Dates

First listed

Jan 12, 2026

Start date

May 22, 2026

Status verified

Sep 2025

Primary completion

Jun 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

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.

Primary Outcome Measure

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

Locations (4)

Find similar trials in Chicago, IL

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