Food Insecurity, Food as Medicine, Hypertension

NCT ID: NCT07011251

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2025-01-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Food is Medicine Program Type

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.

Group Type: OTHER

Food as Medicine Program

Intervention Type: 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.

Survey

Intervention Type: 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.

Interventions

Food as Medicine Program

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.

Intervention Type: BEHAVIORAL

Survey

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alison Gustafson

OTHER

Sponsor Role: lead

Responsible Party

Alison Gustafson

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alison Gustafson, PhD, MPH, RD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Appalachian Regional Healthcare

Floyd, Kentucky, United States

Countries

United States

Other Identifiers

24FIM1255467

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

93234

Identifier Type: -

Identifier Source: org_study_id