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 |
Trial Parameters
Eligibility Fast-Check
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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 meas