Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 24FIM1255467 | Other Grant/Funding Number | American Heart Association |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison Gustafson, PhD, MPH, RD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Appalachian Regional Healthcare | Floyd | Kentucky | 41601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42110255 | Derived | 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. |
Not provided
Not provided
Comparator Arm participants (participants answering "no to assistance but agreeing to the 20-30 minute survey) were not considered enrolled.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Food is Medicine Program - Medically Tailored Meals | 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. 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. |
| FG001 | Food Is Medicine Program - Grocery Prescription | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not all participants completed baseline assessments.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Food is Medicine Program - Medically Tailored Meals | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not all participants completed all baseline and post intervention data assessments. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change Systolic Blood Pressure | captured from the electronic medical record | Participants providing health outcomes at baseline and post intervention | Posted | Mean | 95% Confidence Interval | mmHg | Baseline and week 12 |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Food is Medicine Program - Medically Tailored Meals | Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Gustafson | University of Kentucky | 859-257-1308 | alison.gustafson@uky.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2025 | Jul 29, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005502 | Food |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D003625 | Data Collection |
Not provided
Not provided
The intervention consisted of allocating patients to receive either medically tailored meals or grocery Rx program based on their preferences and resource constraints.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. | 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:
| 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:
| 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. | 12 week |
| 7 days |
| Did not like food options |
|
| Uninterested after reading program information |
|
| BG001 | Food Is Medicine Program - Grocery Prescription Total | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Not all participants completed baseline assessments. | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Not all participants completed baseline assessments. | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change Diastolic Blood Pressure | captured from the electronic medical record | Participants providing health outcomes at baseline and post intervention | Posted | Mean | 95% Confidence Interval | mmHg | Baseline and week 12 |
|
|
|
| Secondary | 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. | Participants providing health outcomes at baseline and post intervention | Posted | Mean | 95% Confidence Interval | cups per day | Baseline and week 12 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | 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:
| Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | 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:
| Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 week |
|
|
|
| Other Pre-specified | Number of Participants Enrolling in FIM From Automated Screening | Not Posted | 7 days | Participants |
| Other Pre-specified | Number of Food Insecure Participants Identified From Face to Face Screening | Not Posted | Baseline | Participants |
| Other Pre-specified | Number of Participants Enrolling in FIM From Face to Face Screening | Not Posted | 7 days | Participants |
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Food Is Medicine Program - Grocery Prescription | Participants allocated to MTM received medically tailored meals for 12-weeks. Participants allocated to Grocery Rx received a $100 grocery voucher to be used on healthy food items. | 0 | 117 | 0 | 117 | 0 | 117 |
Not provided
Not provided
Not provided
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Women |
|
|
| Often/Always |
|
| Don't know |
|
| Very Low |
|
| Very Low |
|
| Often/Always |
|
| Don't know |
|