RECRUITING

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

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Conditions

Food InsecurityHypertensionNutritionDisease Managementrandomized controlled trialkitchen skillsdietsocial determinants of health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-17
Study Completion:2027-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05856591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Fluent in English
  2. 2. Marion County resident
  3. 3. 35-75 years
  4. 4. Systolic BP of ≥120 in prior 12 months
  5. 5. Ability to see and read street signs (self report)
  6. 6. Stable housing with independent access to kitchen, including functional stove or hotplate, oven, refrigerator, and freezer (self report)
  7. 7. Activity independence per functional activities questionnaire (FAQ; \<3 responses of "Require Assistance" and 0 responses of "Dependent")
  8. 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. 9. normal cognition per six-item screener (SIS; score of ≥ 5)
  10. 10. Mean systolic BP of ≥120 from 3 standard BP measurements taken by research staff following standardized wait periods.
  1. 1. lives in nursing home
  2. 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. 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. 4. alcohol consumption ≥ 8 drinks per week for women, or ≥15 drinks per week for men
  5. 5. drug use/abuse (excluding marijuana) per EMR
  6. 6. moving out of area during study timeline
  7. 7. scheduling conflicts with intervention schedule
  8. 8. unwilling to use a touchscreen
  9. 9. unwilling to be on video conferencing
  10. 10. low communicative ability, functional status, or other disorders (examiner rated) that would interfere with interventions and assessments
  11. 11. unable to provide informed consent

Contacts and Locations

Study Contact

Daniel O Clark, PhD
CONTACT
317-274-9292
daniclar@iu.edu
Lyndsi R Moser, BA, CCRP
CONTACT
317-963-7301
lrhabegg@iupui.edu

Principal Investigator

Daniel O Clark, PhD
PRINCIPAL_INVESTIGATOR
Indiana University
Richard Holden, PhD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Eskenazi Health
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Daniel O Clark, PhD, PRINCIPAL_INVESTIGATOR, Indiana University
  • Richard Holden, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-17
Study Completion Date2027-07-30

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2027-07-30

Terms related to this study

Keywords Provided by Researchers

  • randomized controlled trial
  • kitchen skills
  • diet
  • social determinants of health

Additional Relevant MeSH Terms

  • Food Insecurity
  • Hypertension
  • Nutrition
  • Disease Management