Hypertension Clinical Trial
— FoRKSOfficial title:
Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension: An RCT
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, blood draw, and questionnaires.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 30, 2027 |
Est. primary completion date | July 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 75 Years |
Eligibility | 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. At Eligibility Visit: Mean systolic BP of =120 from 24-hour ABPM (from a minimum of 6 daytime readings and 2 nighttime readings) 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 |
Country | Name | City | State |
---|---|---|---|
United States | Eskenazi Health | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic blood pressure | Mean systolic blood pressure in FoRKS experimental arm compared to Enhanced Usual Care | End of treatment at Week 16 | |
Secondary | Hemoglobin A1c (HbA1c) | Mean hemoglobin A1c from blood in FoRKS experimental arm compared to Enhanced Usual Care | End of treatment at Week 16 |
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