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New treatment option for Food Insecurity
Official title Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension
ClinicalTrials.gov ID: NCT05856591
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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...
- 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
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.