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

Hypertension Clinical Trial

— FoRKS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856591
• Other study ID #: 16773
• Secondary ID: R01MD017961
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: July 30, 2027

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: Daniel O Clark, PhD
• Phone: 317-274-9292
• Email: daniclar[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. 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).

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2027
• Est. primary completion date: July 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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. 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:

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

Related Conditions & MeSH terms

• Disease Management
• Food Insecurity
• Hypertension
• Nutrition

Intervention

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

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Mean systolic blood pressure in FoRKS experimental arm compared to Enhanced Usual Care	End of treatment at Week 16
Secondary	Hemoglobin A1c (HbA1c)	Mean hemoglobin A1c from blood in FoRKS experimental arm compared to Enhanced Usual Care	End of treatment at Week 16