Providing food and cooking skills to adults facing food insecurity and high blood pressure
Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension: An RCT
This study is testing whether providing healthy food and cooking skills can help adults with high blood pressure and food insecurity improve their health and nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05856591 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 35-75 living in Marion County with a systolic blood pressure of 120 mm Hg or higher and experiencing food insecurity.
Not a fit: Patients who are not food insecure or have a systolic blood pressure below 120 mm Hg may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve health outcomes and quality of life for patients by addressing both food insecurity and hypertension.
How similar studies have performed: Previous studies have shown promise in similar interventions that combine nutrition education and food access, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.