search
Back to results

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

Primary Purpose

Food Insecurity, Hypertension, Nutrition

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food Resources & Kitchen Skills (FoRKS)
Enhanced Usual Care (EUC)
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Insecurity focused on measuring randomized controlled trial, kitchen skills, diet, social determinants of health

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Fluent in English Marion County resident 35-75 years Systolic BP of ≥120 in prior 6 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) At Eligibility Visit: Mean systolic BP of ≥120 from 24-hour ABPM (from a minimum of 6 daytime readings and 2 nighttime readings) Exclusion Criteria: 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 alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men drug use/abuse (excluding marijuana) per EMR problem list 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

Sites / Locations

  • Eskenazi HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced Usual Care (EUC)

Food Resources & Kitchen Skills (FoRKS)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin A1c (HbA1c)
Mean hemoglobin A1c from blood in FoRKS experimental arm compared to Enhanced Usual Care

Full Information

First Posted
May 4, 2023
Last Updated
July 25, 2023
Sponsor
Indiana University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT05856591
Brief Title
Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension
Acronym
FoRKS
Official Title
Delivering Food Resources & Kitchen Skills (FoRKS) to Adults With Food Insecurity and Hypertension: An RCT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
July 30, 2027 (Anticipated)
Study Completion Date
July 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, blood draw, and questionnaires.
Detailed Description
This behavioral randomized controlled trial will evaluate nutritious food delivery and cooking classes (FoRKS) versus enhanced usual care (EUC) in adults with food insecurity and systolic blood pressure of ≥120 mm Hg. This project seeks to evaluate the potential for hands-on training in food management skills to create lasting improvements in food security, self-efficacy, nutrition, and risk factor reduction in persons with prevalent chronic disease. Adults who give informed consent will complete a 24-hour ambulatory blood pressure measure to confirm blood pressure eligibility. Participants who meet criteria will complete a full baseline assessment, consisting of questionnaires, blood draw, and weight before randomization to one of two arms: Enhanced Usual Care (EUC), consisting of access to existing usual primary care services such as social determinants of health screenings, referrals to food pantries, and assistance enrolling in food assistance programs. They will be enrolled in a 5-week Hypertension Self-Management Education and Support (SMES) class, which is an existing CDC-endorsed program offered at Eskenazi to provide information and skills for managing hypertension (HTN). Food Resources & Kitchen Skills (FoRKS), consisting of the same services as EUC plus home-delivered Mediterranean-style ingredient kits and virtual cooking classes for an additional 11 weeks with embedded lessons in kitchen organization, tool use, nutrition, budgeting, and shopping. Assessments will be completed around Week 16 as the primary endpoint, and around Week 24 for maintenance evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Insecurity, Hypertension, Nutrition, Disease Management
Keywords
randomized controlled trial, kitchen skills, diet, social determinants of health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Food Resources & Kitchen Skills (FoRKS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Food Resources & Kitchen Skills (FoRKS)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Mean systolic blood pressure in FoRKS experimental arm compared to Enhanced Usual Care
Time Frame
End of treatment at Week 16
Secondary Outcome Measure Information:
Title
Hemoglobin A1c (HbA1c)
Description
Mean hemoglobin A1c from blood in FoRKS experimental arm compared to Enhanced Usual Care
Time Frame
End of treatment at Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fluent in English Marion County resident 35-75 years Systolic BP of ≥120 in prior 6 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) At Eligibility Visit: Mean systolic BP of ≥120 from 24-hour ABPM (from a minimum of 6 daytime readings and 2 nighttime readings) Exclusion Criteria: 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 alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men drug use/abuse (excluding marijuana) per EMR problem list 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel O Clark, PhD
Phone
317-274-9292
Email
daniclar@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lyndsi R Moser, BA, CCRP
Phone
317-963-7301
Email
lrhabegg@iupui.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel O Clark, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Holden, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs