Providing food and cooking skills to adults facing food insecurity and high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of a program that delivers nutritious food and teaches cooking skills to adults experiencing food insecurity and hypertension. Participants will be randomly assigned to either the Food Resources & Kitchen Skills (FoRKS) program or Enhanced Usual Care (EUC) to evaluate changes in blood pressure, food security, and nutrition. The study includes comprehensive assessments such as blood pressure monitoring, weight measurements, and questionnaires to gauge the impact of the interventions over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Eskenazi Health
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Daniel O Clark, PhD — Indiana University
• Study coordinator: Daniel O Clark, PhD
• Email: daniclar@iu.edu
• Phone: 317-274-9292

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.