What side effects are associated with this type of intervention?

Common treatments for high blood pressure that focus on dietary changes and lifestyle modifications include the DASH diet, low-sodium diets, and weight reduction programs. These treatments generally have few side effects. The DASH diet and low-sodium diets can sometimes lead to initial adjustments in taste preferences and mild gastrointestinal discomfort. Weight reduction programs may cause temporary fatigue or hunger as the body adjusts to a lower calorie intake. Overall, these non-pharmacologic treatments are well-tolerated and have additional health benefits, such as improved cholesterol levels and reduced risk of cardiovascular events.

What prior FDA approvals exist?

The FDA has approved various medications for the treatment of high blood pressure, including diuretics (e.g., hydrochlorothiazide), beta-blockers (e.g., atenolol), ACE inhibitors (e.g., lisinopril), and calcium channel blockers (e.g., verapamil). While these medications are effective, nonpharmacologic strategies such as dietary modifications have also been studied. The Food Resources & Kitchen Skills (FoRKS) trial focuses on improving dietary habits through the provision of food resources and kitchen skills, which aligns with the Dietary Approaches to Stop Hypertension (DASH) diet. The DASH diet, which emphasizes low sodium intake, high fiber, and low fat, has been shown to significantly lower blood pressure and is recommended as a complementary approach to medication.

What other types of research exist?

Promising alternatives to the FoRKS program for high blood pressure patients include: 1) The DASH (Dietary Approaches to Stop Hypertension) diet, which emphasizes fruits, vegetables, whole grains, and lean proteins while reducing salt intake. 2) Medical Nutrition Therapy (MNT) for type 2 diabetes, which can also benefit hypertensive patients by focusing on balanced, nutrient-dense meals. 3) Community-based lifestyle interventions that combine dietary changes with physical activity, shown to be effective in managing weight and improving cardiovascular health. 4) Optimized food-based recommendations (FBRs) tailored to specific populations, such as those developed for Minangkabau women with dyslipidemia, which can be adapted for hypertensive patients.

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FoRKS Program for High Blood Pressure (FoRKS Trial)

N/A

Recruiting

Led By Daniel O Clark, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 35-75 years

Be older than 18 years old

Must not have

Unwilling to use a touchscreen

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of treatment at week 16

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if delivering healthy food and teaching cooking skills can help adults with high blood pressure and food insecurity. Participants will receive either their regular care or a program that provides food and cooking lessons. The goal is to see if these changes can improve their blood pressure and nutrition.

Who is the study for?

This trial is for English-speaking adults aged 35-75 living in Marion County with stable housing, kitchen access, and high blood pressure. They must be independent in daily activities, experience food insecurity or receive SNAP benefits, have normal cognition, and not consume excessive alcohol.

What is being tested?

The study tests a home-delivered foods and kitchen skills program (FoRKS) against Enhanced Usual Care (EUC) to see their effects on blood pressure control, diabetes management (HbA1c), food security, and nutrition in adults with hypertension.

What are the potential side effects?

Since this trial involves nutritional interventions rather than medications, side effects may include changes in dietary habits or preferences. However, no significant medical side effects are expected from FoRKS or EUC.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not willing to use a touchscreen device.

Select...

I am unable to understand or sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment at week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of treatment at week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment at week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Systolic blood pressure

Secondary study objectives

Hemoglobin A1c (HbA1c)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Food Resources & Kitchen Skills (FoRKS)Experimental Treatment1 Intervention

Participants randomized to FoRKS will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS intervention. Following HTN SMES completion, FoRKS continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16.

Group II: Enhanced Usual Care (EUC)Active Control1 Intervention

Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class ("Hypertension group"), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for high blood pressure include lifestyle modifications and medications. Lifestyle changes, such as adopting a DASH (Dietary Approaches to Stop Hypertension) diet, reducing sodium intake, and increasing physical activity, work by improving vascular health and reducing overall cardiovascular risk. Medications like ACE inhibitors, beta-blockers, and diuretics lower blood pressure by relaxing blood vessels, reducing heart rate, and decreasing blood volume, respectively. For high blood pressure patients, these treatments are crucial as they help prevent complications like heart disease and stroke. The FoRKS trial emphasizes dietary interventions, which can significantly improve blood pressure control by promoting healthier eating habits and providing the skills needed to maintain these changes long-term.