Food InsecurityNCT07011251
Food Insecurity, Food as Medicine, Hypertension
A study testing Food as Medicine Program and Survey in people with Food Insecurity and Hypertension, run by Alison Gustafson at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Food Insecurity, Hypertension
- What is being tested?
- Food as Medicine Program and Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2024to 29 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian Regional Healthcare
Floyd, Kentucky, 41601
About this study
Official title: Development of a User Centered Design Approach for Screening, Referral, and Enrollment in Food as Medicine Among Adults
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
- Being tested
- Food as Medicine Program, Survey
- Keywords
- Food as medicine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food as Medicine ProgramBehavioural
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.
SurveyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Food as Medicine Program; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Systolic Blood Pressure
captured from the electronic medical record
Measured: Baseline and week 12
Change Diastolic Blood Pressure
captured from the electronic medical record
Measured: Baseline and week 12
Secondary outcomes (5)
Change in Dietary Intake
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.
Measured: Baseline and week 12
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
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.
Measured: Baseline
Number of Participants Reporting Food Insecurity
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.
Measured: Baseline
Number of Participants Reporting Food Insecurity
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.
Measured: 12 weeks
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
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.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 Aug 2024
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention consisted of allocating patients to receive either medically tailored meals or grocery Rx program based on their preferences and resource constraints.
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alison Gustafson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alison Gustafson, University of Kentucky
- Investigators
- Alison Gustafson, PhD, MPH, RD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011251
- Sponsor's protocol ID
- 93234
- Other IDs
- 24FIM1255467
- Status last verified
- Mar 2026
- First submitted
- 30 May 2025
- Last updated
- 1 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gustafson A, Lauckner C, Bush JL, Dimond E, Serrano CM, Mayfield C, Steeves ETA. Feasibility study of a screening decision tool for allocating adults into food is medicine programs as an effective approach to target clinical and dietary outcomes among rural and urban adults. Front Public Health. 2026 Apr 23;14:1783076. doi: 10.3389/fpubh.2026.1783076. eCollection 2026.
PubMed 42110255
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a User Centered Design Approach for Screening, Referral, and Enrollment in Food as Medicine Among Adults
- ClinicalTrials.gov ID
- NCT07011251
- Acronym / sponsor ID
- 93234
- Conditions
- Food Insecurity, Hypertension
- Keywords
- Food as medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Alison GustafsonUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 8 Jun 2025 (actual)
- Results
- Posted 1 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention consisted of allocating patients to receive either medically tailored meals or grocery Rx program based on their preferences and resource constraints.
| Arm | Type | Receives |
|---|---|---|
| Food is Medicine Program Type | Other | Behavioral: Food as Medicine Program, Other: SurveyPatients 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food as Medicine ProgramGrocery 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. | Behavioural | Food is Medicine Program Type |
| SurveyParticipants 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. | Other | Food is Medicine Program Type |
Primary outcome
Change Systolic Blood Pressure
Time frame: Baseline and week 12
captured from the electronic medical record
Change Diastolic Blood Pressure
Time frame: Baseline and week 12
captured from the electronic medical record
5 secondary outcomes
Change in Dietary Intake
Time frame: Baseline and week 12
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Time frame: Baseline
Number of Participants Reporting Food Insecurity
Time frame: Baseline
Number of Participants Reporting Food Insecurity
Time frame: 12 weeks
Number of Participants Who Answered Never/Rarely, Sometimes, Often/Always, and Don't Know to the Nutrition Security Question
Time frame: 12 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42110255Gustafson A, Lauckner C, Bush JL, Dimond E, Serrano CM, Mayfield C, Steeves ETA. Feasibility study of a screening decision tool for allocating adults into food is medicine programs as an effective approach to target clinical and dietary outcomes among rural and urban adults. Front Public Health. 2026 Apr 23;14:1783076. doi: 10.3389/fpubh.2026.1783076. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison Gustafson, PhD, MPH, RD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food as Medicine Program and Survey in people with Food Insecurity and Hypertension, run by Alison Gustafson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Systolic Blood Pressure (time frame: Baseline and week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07011251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.