FORKS RCT
Enrolling By Invitation
35-75 years
All
Phase
N/A
200 participants needed
Brief description of study
This project will evaluate FoRKS (home delivered foods and kitchen skills intervention) versus enhanced usual care (EUC) for middle-aged safety-net primary care patients who screen positive for food insecurity and hypertension. This is a randomized clinical trial (RCT) testing the feasibility and initial efficacy of FoRKS to impact mean systolic blood pressure immediately post-intervention.
Detailed description of study
EUC consists of SDOH screening,
referrals to food pantries, assistance enrolling in food programs (e.g., SNAP),
and access to CDC-approved HTN Self-Management Education Series (SMES) and, if
applicable, DM2 SMES. In addition to the EUC offerings, participants
randomized to FoRKS will receive home-delivered ingredient kits and Webex
cooking classes with embedded lessons in kitchen organization, tool use,
nutrition, budgeting, and shopping.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hypertension, Type 2 Diabetes, food insecurity
-
Age: Between 35 Years - 75 Years
-
Gender: All
Inclusion Criteria:
1.
Fluent in English
2.
Marion County resident
3.
35-75 years
4.
Systolic
BP of ≥120 in prior 12 months from a primary care visit
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.
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
- alcohol consumption ≥ 8 drinks per week for women, or≥15 drinks per week for men
- drug use/abuse (excluding marijuana) per EMR
Updated on
01 Aug 2024.
Study ID: 16773; INTM-IIR-FORKS-RCT
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
