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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Food Insecurity, Hypertension, Nutrition, Disease Management

Intervention / Treatment
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* Behavioral: Food Resources & Kitchen Skills (FoRKS)
* Behavioral: Enhanced Usual Care (EUC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enhanced Usual Care (EUC)<br>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)<br>* Enhanced Usual Care (EUC) includes 5 weeks of hypertension classes.<br>|
| Experimental: Food Resources & Kitchen Skills (FoRKS)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Mean systolic blood pressure in FoRKS experimental arm compared to Enhanced Usual Care | End of treatment at Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) | Mean hemoglobin A1c from blood in FoRKS experimental arm compared to Enhanced Usual Care | End of treatment at Week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, kitchen skills, diet, social determinants of health