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OpenTrials
Completed

NCT Number: NCT07011251

Food Insecurity, Food as Medicine, Hypertension

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.

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Key information

Conditions

Food Insecurity Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Appalachian Regional Healthcare

Floyd, Kentucky, 41601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change Systolic Blood Pressure

    Time frame: Baseline and week 12

    captured from the electronic medical record

  2. Change Diastolic Blood Pressure

    Time frame: Baseline and week 12

    captured from the electronic medical record

Secondary outcomes

  1. Change in Dietary Intake

    Time frame: Baseline and week 12

    Dietary intake is captured with the Dietary Screener Questionnaire (DSQ-10). Responses to these dietary intake questions are converted to daily cup equivalent estimates (e.g., 1.2 cups of vegetables per day, 1.1 cups of fruit per day, 2.3 cups of FVs per day) of daily FV intake. The 2020-2025 United States Dietary Guidelines for Americans recommend consuming 2 to 3 cups of vegetables per day and 1.5 to 2 cups of fruit per day.

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

    Time frame: Baseline

    The one item Gretchen Swanson Nutrition Security question will be asked as follows:In the past month, how often did the participant worry that the food bought wouldn't provide enough nutrients for the family, even if the participant had enough to eat? Response options are never, rarely, sometimes, often, always, don't know. We collapsed the categories of never/rarely; sometimes; often/always; don't know based on distribution of the data.

  3. Number of Participants Reporting Food Insecurity

    Time frame: Baseline

    USDA 6-item food insecurity survey Scores range from 0-6 with higher scores equating to lower food security. Categories were created with low, marginal, and very low based on USDA scoring algorithm. Food security status is assigned as follows:

    • Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale)
    • Raw score 2-4-Low food security
    • Raw score 5-6-Very low food security For some reporting purposes, the food security status of households with raw score 0-1 is described as food secure and the two categories "low food security" and "very low food security" in combination are referred to as food insecure.

  4. Number of Participants Reporting Food Insecurity

    Time frame: 12 weeks

    USDA 6-item food insecurity survey Scores range from 0-6 with higher scores equating to lower food security. Food security status is assigned as follows:

    • Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale)
    • Raw score 2-4-Low food security
    • Raw score 5-6-Very low food security For some reporting purposes, the food security status of households with raw score 0-1 is described as food secure and the two categories "low food security" and "very low food security" in combination are referred to as food insecure.

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

    Time frame: 12 week

    The one item Gretchen Swanson Nutrition Security question will be asked as follows:In the past month, how often did the participant worry that the food bought wouldn't provide enough nutrients for the family, even if the participant had enough to eat? Response options are never, rarely, sometimes, often, always, don't know. We collapsed the categories of never/rarely; sometimes; often/always; don't know based on distribution of the data.

Other outcomes

  1. Number of Participants Enrolling in FIM From Automated Screening

    Time frame: 7 days

  2. Number of Food Insecure Participants Identified From Face to Face Screening

    Time frame: Baseline

  3. Number of Participants Enrolling in FIM From Face to Face Screening

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Alison Gustafson

Other

Registry information

Official study title

Development of a User Centered Design Approach for Screening, Referral, and Enrollment in Food as Medicine Among Adults

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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