Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension
Recruiting · NCT05856591 · Interventional (participants receive a specific treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
Enhanced Usual Care (EUC)Food Resources & Kitchen Skills (FoRKS)
What this trial is about
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.
Who can take part
Age range
35 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Fluent in English
- Marion County resident
- 35-75 years
- Systolic BP of ≥120 in prior 12 months
- Ability to see and read street signs (self report)
- Stable housing with independent access to kitchen, including functional stove or hotplate, oven, refrigerator, and freezer (self report)
- Activity independence per functional activities questionnaire (FAQ; \<3 responses of "Require Assistance" and 0 responses of "Dependent")
- 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.
- normal cognition per six-item screener (SIS; score of ≥ 5)
- Mean systolic BP of ≥120 from 3 standard BP measurements taken by research staff following standardized wait periods.
Exclusion criteria
- lives in nursing home
- 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
- 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
- alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
- drug use/abuse (excluding marijuana) per EMR
- moving out of area during study timeline
- scheduling conflicts with intervention schedule
- unwilling to use a touchscreen
- unwilling to be on video conferencing
- low communicative ability, functional status, or other disorders (examiner rated) that would interfere with interventions and assessments
- unable to provide informed consent
Where it is running
1 location listed across 1 US state.
- Eskenazi Health - Indianapolis, Indiana, United States