Food is Medicine for High Blood Pressure and Obesity

(FIM+DASH Trial)

Not yet recruiting at 3 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Illinois at Chicago

Disqualifiers: Cancer, Cardiovascular event, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special diet plan called FIM+DASH can assist adults with high blood pressure (hypertension) and obesity. Participants will either follow this diet plan, which includes home food delivery and cooking lessons, or continue with their usual care. Researchers seek to assess the diet's impact on blood pressure, diet quality, weight, and waist size, and they aim to understand how this approach could integrate into everyday life. Adults with high blood pressure, a BMI of 30 or more, and access to a smartphone might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the DASH diet, part of the FIM+DASH treatment, is generally safe and easy for most people to follow. Studies have found that the DASH diet can significantly lower blood pressure. It offers a flexible and balanced eating plan that supports heart health. An 8-week controlled study tested this diet and found it reduced heart disease risk without major side effects.

No specific negative effects have been linked to the DASH diet, suggesting it is safe for most people. Although this trial is in the early stages, enough safety evidence usually suggests the treatment is well-tolerated. However, as with any trial, researchers will closely monitor participants for any problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the FIM+DASH treatment because it approaches high blood pressure and obesity by combining dietary changes with medical care. Unlike typical treatments that often rely on medications, this method emphasizes the Dietary Approaches to Stop Hypertension (DASH) diet, which is rich in fruits, vegetables, and low-fat dairy, and has been shown to lower blood pressure. By integrating food as a central component of care, this approach may offer a more natural and sustainable way to manage these conditions, potentially reducing the need for medication and its associated side effects. This could lead to healthier lifestyle changes that have long-lasting benefits.

What evidence suggests that this trial's treatments could be effective for high blood pressure and obesity?

Studies have shown that the DASH diet, which stands for Dietary Approaches to Stop Hypertension, can significantly lower blood pressure in people with high blood pressure. Research also shows that the DASH diet improves heart health, especially for those at higher risk. In this trial, participants in the FIM Intervention Arm will experience the "Food is Medicine" approach, which uses food to help treat health conditions. Combined with the DASH diet, this approach has shown promise in improving diet quality and managing weight. Overall, these strategies help control high blood pressure and obesity by encouraging healthier eating habits. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure and obesity. Participants will be involved in a 24-week study, which includes receiving home food deliveries and learning cooking skills to promote healthy eating habits.

Inclusion Criteria

Able to speak/read English

I am an adult with high blood pressure (130/80 mmHg or higher).

Access to a smartphone with text-messaging capability

Exclusion Criteria

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.

I am currently receiving treatment for cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the FIM+DASH intervention, which includes culinary skill-building, DASH diet adherence support, and home food delivery

12 weeks

Weekly home food delivery, in-person group sessions, and one-on-one check-ins

Maintenance

Participants continue with the maintenance phase of the FIM+DASH intervention to support ongoing adherence to the DASH diet and hypertension self-management

12 weeks

Follow-up

Participants are monitored for blood pressure, diet adherence, body weight, and waist circumference

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FIM+DASH

Trial Overview

The trial tests the 'Food is Medicine' approach combined with the DASH diet against usual care. It's designed to see if this intervention can better control blood pressure, improve diet quality, reduce body weight, and decrease waist circumference over six months.

How Is the Trial Designed?

Group I: FIM Intervention Arm Experimental Treatment 1 Intervention

Group II: FIM Usual Care Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07332741

FIM+DASH: Food is Medicine Intervention to Promote ...

The goal of this clinical trial is to treat both hypertension and obesity in adults using a food is medicine framework.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10551663/

DASH Diet: A Review of Its Scientifically Proven Hypertension ...

Results indicated that all three diets contributed to improved blood pressure levels with greater reduction seen with the modified DASH diet ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/CIR.0000000000001343

A Systematic Review of “Food Is Medicine” Randomized ...

The primary outcome examined was change in blood pressure. Both the control group and intervention group experienced small declines from ...

4.

nhlbi.nih.gov

nhlbi.nih.gov/education/dash-eating-plan

DASH Eating Plan | NHLBI, NIH

DASH (Dietary Approaches to Stop Hypertension) is a flexible and balanced eating plan that helps create a heart-healthy eating style for life.

5.

cambridge.org

cambridge.org/core/journals/british-journal-of-nutrition/article/effects-of-the-dietary-approach-to-stop-hypertension-dash-diet-on-cardiovascular-risk-factors-a-systematic-review-and-metaanalysis/C3B37FC59A6FE257F3750C429C1251E6

Effects of the Dietary Approach to Stop Hypertension ...

The DASH diet improved cardiovascular risk factors and appeared to have greater beneficial effects in subjects with an increased cardiometabolic risk.

6.

jmir.org

jmir.org/2008/4/e52/

Weight, Blood Pressure, and Dietary Benefits After 12 ...

To design an Internet-based nutrition education program and to explore its effect on weight, blood pressure, and eating habits after 12 months of participation.

7.

nutritionsource.hsph.harvard.edu

nutritionsource.hsph.harvard.edu/healthy-weight/diet-reviews/dash-diet/

Diet Review: DASH - The Nutrition Source

The DASH diet was found to lower cardiovascular risk in a controlled 8-week trial looking at participants randomized to consume either a DASH diet (low in total ...