Food Resources & Kitchen Skills (FoRKS) for High Blood Pressure

Eskenazi Health, Indianapolis, IN
High Blood Pressure+3 More ConditionsFood Resources & Kitchen Skills (FoRKS) - Behavioral
Eligibility
35 - 75
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • High Blood Pressure
  • Food Insecurity
  • Nutrition
  • Disease Management

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: End of treatment at Week 16

Week 16
Healthy Eating Index score computed from the Automated Self-Administered Dietary Assessment (ASA24)
Hemoglobin A1c (HbA1c)
Mean food security score as measured by Four Domain Food Insecurity Scale (4D-FIS)
Systolic blood pressure

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Enhanced Usual Care (EUC)
1 of 2
Food Resources & Kitchen Skills (FoRKS)
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Food Resources & Kitchen Skills (FoRKS) · No Placebo Group · N/A

Food Resources & Kitchen Skills (FoRKS)
Behavioral
Experimental Group · 1 Intervention: Food Resources & Kitchen Skills (FoRKS) · Intervention Types: Behavioral
Enhanced Usual Care (EUC)
Behavioral
ActiveComparator Group · 1 Intervention: Enhanced Usual Care (EUC) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: end of treatment at week 16

Who is running the clinical trial?

Indiana UniversityLead Sponsor
910 Previous Clinical Trials
775,801 Total Patients Enrolled
National Institute on Minority Health and Health Disparities (NIMHD)NIH
316 Previous Clinical Trials
1,322,793 Total Patients Enrolled
Daniel O Clark, PhDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
1,248 Total Patients Enrolled
Richard Holden, PhDPrincipal InvestigatorIndiana University

Eligibility Criteria

Age 35 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.