Food Insecurity, Food as Medicine, Hypertension

NCT07011251 | Completed Results

• 2 other identifiers: 9323424FIM1255467
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Development of a user centered design to understand how a tailored food is medicine program based on user preferences and needs improves engagement and clinical outcomes. The study will examine how patients, screened either face to face or through automated for food insecurity, engage in a food is medicine program over 12-weeks.

Conditions

Food Insecurity; Hypertension

Keywords

Food as medicine

Outcome Measures

Primary Outcomes (2)

• Change Systolic Blood Pressure

  captured from the electronic medical record

  Baseline and week 12

• Change Diastolic Blood Pressure

  captured from the electronic medical record

  Baseline and week 12

Secondary Outcomes (5)

• Change in Dietary Intake

  Baseline and week 12

• Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question

  Baseline

• Number of Participants Reporting Food Insecurity

  Baseline

• Number of Participants Reporting Food Insecurity

  12 weeks

• Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question

  12 week

Other Outcomes (3)

• Number of Participants Enrolling in FIM From Automated Screening

  7 days

• Number of Food Insecure Participants Identified From Face to Face Screening

  Baseline

• Number of Participants Enrolling in FIM From Face to Face Screening

  7 days

Study Arms (1)

Food is Medicine Program Type

OTHER

Patients were screened for food insecurity either face to face or automated based on standard of care practice at their respective healthcare site. Patients were referred to the study team to utilize a screening decision tool to allocate them to receive either Medically tailored meals or a grocery voucher program. Participants then received their program for 12-weeks. Participants then completed post intervention survey.

Behavioral: Food as Medicine Program; Other: Survey

Interventions

Food as Medicine Program BEHAVIORAL

Grocery Prescription - participants will receive a card loaded with $100 per month to be used on the Instacart Fresh Funds program website/app or a SodaHealth grocery prescription card to be used inside a Kroger or Food City stores. Patients who select grocery delivery where Instacart is not available will receive Food City meals for the same value. or 2) Medically Tailored Meals (MTM) - participants receive approximately 5 frozen meals per week from Mom's Meals that follow an approved diet for those with hypertension. Participants will complete screening questions (screening decision tree attached) after informed consent to determine which food package the participant will receive. The screening decision tree is a tool that asks about kitchen availability for preparing foods, skills, and access to transportation. Depending on how the patient answers they will receive either grocery prescription or MTM for 3-months or 12-weeks.

Food is Medicine Program Type

Survey OTHER

Participants answering "no" to assistance but agreeing to the 20-30 minute survey will receive a direct link to a survey related to reasons for not wanting assistance to answer questions at one time point.

Food is Medicine Program Type

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Hypertension in last 12 months
• Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
• English or Spanish speaking
• No plans to move from the area for at least 1 year
• Willing and able to accept text messages
• Free living to the extent that participant has control over dietary intake
• Willing and able to provide written informed consent and participate in all study activities.

You may not qualify if:

• Participant in weight research intervention in last 12 months
• Considering bariatric surgery in the next year or prior bariatric surgery
• Lack of safe, stable residence and ability to store meals
• Lack of telephone which can receive text messages
• Pregnancy/breastfeeding or intended pregnancy in the next year
• Known drug or alcohol misuse in the past 2 years

Sponsors & Collaborators

• Alison Gustafson: lead

Study Sites (1)

Appalachian Regional Healthcare

Floyd, Kentucky, 41601, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Food; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Alison Gustafson
• Organization: University of Kentucky

alison.gustafson@uky.edu

859-257-1308

Study Officials

• Alison Gustafson, PhD, MPH, RD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The intervention consisted of allocating patients to receive either medically tailored meals or grocery Rx program based on their preferences and resource constraints.

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: August 16, 2024
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: April 1, 2026
• Results First Posted: April 1, 2026

Record last verified: 2026-03

Locations

US (1)