Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05856591
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Food Resources & Kitchen Skills (FoRKS) — BEHAVIORAL
    Food 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) — BEHAVIORAL
    Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.

Study Details

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.

Key Dates

Start date
Apr 17, 2023
Status verified
Feb 2026
Primary completion
Jul 30, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Systolic blood pressure [ Time Frame: End of treatment at Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eskenazi HealthIndianapolisIndiana46202-

Find similar trials in Indianapolis, IN

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Eskenazi Health· Indianapolis, IN

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