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Search / Trial NCT05856591

Delivering Food Resources & Kitchen Skills (FoRKS) to Adults with Food Insecurity and Hypertension

Launched by INDIANA UNIVERSITY · May 4, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Randomized Controlled Trial Kitchen Skills Diet Social Determinants Of Health

ClinConnect Summary

**Clinical Trial Summary: Delivering Food Resources & Kitchen Skills (FoRKS)**

This clinical trial is looking at how a program called Food Resources & Kitchen Skills (FoRKS) can help adults who struggle with both food insecurity (not having enough food) and high blood pressure (hypertension). The main goal is to see if providing healthy food and teaching cooking skills can improve participants' blood pressure and overall nutrition. Researchers will compare the effects of the FoRKS program to standard care, which does not include these resources. Participants will take part in activities like monitoring their blood pressure, providing blood samples, and answering questions about their health and food situation.

To join the trial, you need to be between 35 and 75 years old, live in Marion County, and have had high blood pressure recorded in the last year. You should also have access to a kitchen and be able to prepare meals independently. If you often worry about running out of food or can’t afford enough to eat, you might be eligible. Participants will undergo some health checks and have access to valuable resources aimed at improving their nutrition and managing their blood pressure. If you have any questions or think you might be eligible, consider reaching out for more information!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Fluent in English
  • 2. Marion County resident
  • 3. 35-75 years
  • 4. Systolic BP of ≥120 in prior 12 months
  • 5. Ability to see and read street signs (self report)
  • 6. Stable housing with independent access to kitchen, including functional stove or hotplate, oven, refrigerator, and freezer (self report)
  • 7. Activity independence per functional activities questionnaire (FAQ; \<3 responses of "Require Assistance" and 0 responses of "Dependent")
  • 8. Food insecurity per first two items of USDA 18-item survey with ≥ 1 response of "Often true" or "Sometimes true" \[1) Within the past 12 months, you worried that your food would run out before you got the money to buy more; 2) Within the past 12 months, the food you bought just didn't last and you didn't have money to get more.\] OR currently listed as food insecure in Eskenazi EMR; OR currently receiving SNAP benefits.
  • 9. normal cognition per six-item screener (SIS; score of ≥ 5)
  • 10. Mean systolic BP of ≥120 from 3 standard BP measurements taken by research staff following standardized wait periods.
  • Exclusion Criteria:
  • 1. lives in nursing home
  • 2. diagnosis of dementia or Alzheimer disease or mild cognitive impairment; Parkinson disease; brain tumor/infection/surgery (within the last 10 years with residual symptoms and/or functional loss/deficit, such as impaired learning, memory, or communication); psychosis, schizophrenia, or bipolar disorder
  • 3. ICD 10 code I11/hypertensive heart disease, ICD 10 code I12/hypertensive CKD, ICD 10 code I13/hypertensive heart disease and CKD, ICD 10 code I15, or ICD 10 code I16
  • 4. alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
  • 5. drug use/abuse (excluding marijuana) per EMR
  • 6. moving out of area during study timeline
  • 7. scheduling conflicts with intervention schedule
  • 8. unwilling to use a touchscreen
  • 9. unwilling to be on video conferencing
  • 10. low communicative ability, functional status, or other disorders (examiner rated) that would interfere with interventions and assessments
  • 11. unable to provide informed consent

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Trial Officials

Daniel O Clark, PhD

Principal Investigator

Indiana University

Richard Holden, PhD

Principal Investigator

Indiana University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported