Delivering Food Resources & Kitchen Skills (FoRKS) to Adults with Food Insecurity and Hypertension: an RCT

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
United States
Indiana
Eskenazi Health
RECRUITING
Indianapolis
Contact Information
Primary
Daniel O Clark, PhD
daniclar@iu.edu
317-274-9292
Backup
Lyndsi R Moser, BA, CCRP
lrhabegg@iupui.edu
317-963-7301
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2027-07-30
Participants
Target number of participants: 200
Treatments
Active_comparator: Enhanced Usual Care (EUC)
Participants randomized to EUC will have access to existing usual primary care services. They will also be enrolled in Hypertension Self-Management Education and Support (SMES) class (Hypertension group), which is an existing CDC-endorsed program offered at Eskenazi Health to provide information and skills for managing hypertension (HTN). Classes are led by registered dietitians via Webex.
Experimental: Food Resources & Kitchen Skills (FoRKS)
Participants randomized to FoRKS will attend weekly HTN SMES classes separately from EUC participants. SMES classes will include the EUC curriculum stated above and an introduction to the upcoming FoRKS intervention.~Following HTN SMES completion, FoRKS continues with home-delivered Mediterranean-style ingredient kits, food management lessons, and hands-on cooking classes in one's own kitchen. Classes are led by registered dietitians via Webex. Classes are held twice per week thru Week 12, then only once per week through Week 16.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Leads: Indiana University

This content was sourced from clinicaltrials.gov