Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorIndiana University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Fluent in English
Marion County resident
35-75 years
Systolic BP of ≥120 in prior 12 months
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Food Resources & Kitchen Skills (FoRKS)
BehavioralFood Resources \& Kitchen Skills (FoRKS) includes 5 weeks of hypertension classes followed by 11 weeks of home-delivered Mediterranean-style ingredient kits and virtual cooking classes with embedded lessons in kitchen organization, tool use, nutrition, budgeting, and shopping.
Enhanced Usual Care (EUC)
BehavioralEnhanced Usual Care (EUC) includes 5 weeks of hypertension classes.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Enhanced Usual Care (EUC)Active comparator 1 intervention
Group B: Food Resources & Kitchen Skills (FoRKS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Systolic blood pressure
Mean systolic blood pressure in FoRKS experimental arm compared to Enhanced Usual Care
Time frame
End of treatment at Week 16Secondary outcomes
1
Hemoglobin A1c (HbA1c)
Mean hemoglobin A1c from blood in FoRKS experimental arm compared to Enhanced Usual Care
Time frame
End of treatment at Week 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov