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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
Activity independence per functional activities questionnaire (FAQ; <3 responses of 'Require Assistance' and 0 responses of 'Dependent')
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment at week 16
Awards & highlights

FoRKS Trial Summary

This trial will test how a food/cooking program can improve nutrition, health, and food security for those with high BP and food insecurity.

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.Check my eligibility
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.See study design
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.

FoRKS Trial 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.
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I can do most daily activities by myself.

FoRKS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Systolic blood pressure
Secondary outcome measures
Hemoglobin A1c (HbA1c)

FoRKS 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.

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Who is running the clinical trial?

Indiana UniversityLead Sponsor
977 Previous Clinical Trials
983,113 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
376 Previous Clinical Trials
1,214,956 Total Patients Enrolled
Daniel O Clark, PhDPrincipal InvestigatorIndiana University
3 Previous Clinical Trials
1,376 Total Patients Enrolled

Media Library

Enhanced Usual Care (EUC) Clinical Trial Eligibility Overview. Trial Name: NCT05856591 — N/A
Disease Management Research Study Groups: Enhanced Usual Care (EUC), Food Resources & Kitchen Skills (FoRKS)
Disease Management Clinical Trial 2023: Enhanced Usual Care (EUC) Highlights & Side Effects. Trial Name: NCT05856591 — N/A
Enhanced Usual Care (EUC) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856591 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research effort inviting elderly participants?

"Patients between the ages of 35 and 75 who meet certain criteria can be enrolled in this clinical trial."

Answered by AI

To whom does this research opportunity extend?

"To participate in this clinical trial, individuals must have hypertension and be aged between 35 and 75. A total of 200 patients are being sought for the experiment."

Answered by AI

Are there vacancies available in this trial for participants?

"According to the clinical trials website, patient recruitment for this trial is currently ongoing. The study was initially published on April 17th 2023 and has since been refined; with its last update being made on May 4th 2023."

Answered by AI

How many participants are engaged in this investigation?

"Affirmative. According to clinicaltrials.gov, the trial is still open for recruitment and was originally published on April 17th 2023 with its last update occurring on May 4th of the same year. The study requires 200 participants from a single medical centre."

Answered by AI
~133 spots leftby Jul 2027