Clinical trial NCT05856591: Delivering Food Resources & Kitchen Skills (FoRKS) to Adults with Food Insecurity and Hypertension
Official title: Delivering Food Resources & Kitchen Skills (FoRKS) to Adults with Food Insecurity and Hypertension: an RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity
Hypertension
Nutrition
Disease Management
Keywords: randomized controlled trial
kitchen skills
diet
social determinants of health
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 pass the telephone screen will be invited to complete a blood pressure check for final eligibility determination. Participants must receive an average systolic read of ≥120 mmHG across 3 standard BP readings with designated wait periods; a maximum of 5 readings may be attempted to receive 3 successful measurements necessary to calculate the average. Participants who meet criteria and give informed consent will complete a full baseline assessment consisting of questionnaires, finger stick for A1c point-of-care testing, weight, and 24-hour ambulatory blood pressure 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure
timeFrame: End of treatment at Week 16
Secondary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: End of treatment at Week 16
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Daniel O Clark, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Richard Holden, PhD
role: PRINCIPAL_INVESTIGATOR
References: