NCT05856591

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Apr 2023Jul 2027

Study Start

First participant enrolled

April 17, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

4.3 years

First QC Date

May 4, 2023

Last Update Submit

February 3, 2026

Conditions

Food InsecurityHypertensionNutritionDisease Management

Keywords

randomized controlled trialkitchen skillsdietsocial determinants of health

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Mean systolic blood pressure in FoRKS experimental arm compared to Enhanced Usual Care

    End of treatment at Week 16

Secondary Outcomes (1)

  • Hemoglobin A1c (HbA1c)

    End of treatment at Week 16

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care (EUC)

Food Resources & Kitchen Skills (FoRKS)

EXPERIMENTAL

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.

Behavioral: Food Resources & Kitchen Skills (FoRKS)

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.

Food Resources & Kitchen Skills (FoRKS)
Enhanced Usual Care (EUC)BEHAVIORAL

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

Enhanced Usual Care (EUC)

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in English
  • Marion County resident
  • 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.

You may not qualify if:

  • lives in nursing home
  • 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
  • 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
  • moving out of area during study timeline
  • scheduling conflicts with intervention schedule
  • unwilling to use a touchscreen
  • unwilling to be on video conferencing
  • low communicative ability, functional status, or other disorders (examiner rated) that would interfere with interventions and assessments
  • unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Daniel O Clark, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Richard Holden, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel O Clark, PhD

CONTACT

317-274-9292daniclar@iu.edu

Lyndsi R Moser, BA, CCRP

CONTACT

317-963-7301lrhabegg@iupui.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 12, 2023

Study Start

April 17, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)