NCT05856591 Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension
| NCT ID | NCT05856591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Food Insecurity |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-04-17 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-04-17 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to determine the impact of a home-delivered foods and kitchen skills program on health and nutrition in adults with high blood pressure and food insecurity. Researchers will compare Food Resources \& Kitchen Skills (FoRKS) and Enhanced Usual Care (EUC) to evaluate the effects on mean systolic blood pressure (SPB), HbA1c, food security and nutrition. Participants will complete 24-hr blood pressure monitoring, standard blood pressure measurements, weight, finger stick for A1c point-of-care testing, and questionnaires.
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
Contact & Investigator
Daniel O Clark, PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05856591 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 75 Years, studying Food Insecurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05856591 currently recruiting?
Yes, NCT05856591 is actively recruiting participants. Contact the research team at daniclar@iu.edu for enrollment information.
Where is the NCT05856591 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT05856591 clinical trial?
NCT05856591 is sponsored by Indiana University. The principal investigator is Daniel O Clark, PhD at Indiana University. The trial plans to enroll 200 participants.