Recruiting

Food Resources

Sponsor:

Indiana University

Code:

NCT05856591

Conditions

Food Insecurity

Hypertension

Nutrition

Disease Management

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Food Resources & Kitchen Skills (FoRKS)

Enhanced Usual Care (EUC)

Study Details

Brief 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.

Conditions

Food Insecurity

Hypertension

Nutrition

Disease Management

Study ID

NCT05856591

Start date

Apr 17, 2023

Status verified date

Jul, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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. Mean systolic BP of ≥120 from 3 standard BP measurements taken by research staff following standardized wait periods.

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Food Resources & Kitchen Skills (FoRKS)

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)

Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Daniel O Clark, PhD

317-274-9292daniclar@iu.edu

Lyndsi R Moser, BA, CCRP

317-278-7727lrhabegg@iu.edu

Locations

Eskenazi Health

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • randomized controlled trial
  • kitchen skills
  • diet
  • social determinants of health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-22.