Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05856591

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

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

Official title: Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension: An RCT

Key Details

Gender

All

Age Range

35 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-04-17

Completion Date

2027-07-30

Last Updated

2026-02-05

Healthy Volunteers

Conditions

Food Insecurity Hypertension Nutrition Disease Management

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Enhanced Usual Care (EUC)

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

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

Locations (1)

Eskenazi Health

Indianapolis, Indiana, United States