Food InsecurityNCT06784310
Food Insecurity, Social Determinants of Health
A study testing Medically Tailored Meals, Grocery Prescription and Medically Tailored Meals and Grocery Prescription in people with Food Insecurity and Type 2 Diabetes Mellitus (T2DM), run by Alison Gustafson at 1 site in United States.
Trial summary
Food is Medicine for the whole will test an intervention which provides medically tailored meals, or grocery voucher cards, or a combination of these food and nutrition resources to a caregiver and children living in the household. Read more about this study
- Who is it for?
- Ages 6 to 64 years
- Conditions the study is for
- Food Insecurity, Type 2 Diabetes Mellitus (T2DM), Hypertension
- What is being tested?
- Medically Tailored Meals, Grocery Prescription and Medically Tailored Meals and Grocery Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 5 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have at least one child ages 6-17, inclusive, living in the household with the adult at least 50% of the time
- Diagnosis of stage 3 or 4 Hypertension in last 12 months, or diagnosis of T2DM in the last 12 months
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English 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 diabetes, nutrition, or 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
- History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured > 5 years ago or in remission
Show all 10Show fewer
- Advanced kidney disease (estimated creatinine clearance < 30 mL/min)
- Known drug or alcohol misuse in the past 2 years
- Known psychosis or major psychiatric illness that prevents participation with study activities
- Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feeding the Family: Nutrition Security Intervention to Improve Physical and Mental Health Among Low-resource Families
Food is Medicine for the whole will test an intervention which provides medically tailored meals, or grocery voucher cards, or a combination of these food and nutrition resources to a caregiver and children living in the household. The study will examine how providing healthy tailored food and nutrition services can improve health outcomes, such as blood pressure and cholesterol levels.
Read the detailed description
The proposal addresses the key goals of Humana Foundation related to, "Effective and equitable interventions to increase access to healthy diets promoting physical \& mental health benefits". The interdisciplinary team comprised of clinicians, researchers in public health, nutrition, mental health, and community partners will evaluate the effectiveness of a whole family nutrition security intervention to provide evidence supporting key policies on reimbursement of health-related social needs (HRSN) as a medically covered benefit. The study team will use a user-centered approach to examine how to engage the whole family in the short-term, while creating a sustainable model for clinic and community partnerships to use in the long-term. This proposal aims to answer the question "How can a food as medicine choice model with tailored dose improve health outcomes across the family?". To answer this question, investigators are proposing a pragmatic randomized control trial (pRCT) using a 2X2 factorial design among Medicaid families, adults with children ages 5-18, with an adult diagnosed with either hypertension or Type 2 Diabetes (T2DM), child has a BMI categorized as obese or overweight, and report being food insecure. The pRCT will take place in Louisville, Kentucky with University of Louisville Health as the clinic provider, in an urban setting with a high percentage of adults reporting race/ethnicity as Black or African American. The community partners are Dare to Care Food Bank as the medically tailored meal (MTM) provider, and Kroger Health/Soda Health as the grocery prescription provider (GP).
- Being tested
- Medically Tailored Meals, Grocery Prescription, Medically Tailored Meals and Grocery Prescription, Nutritional Counseling
- Keywords
- Food as medicine
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored MealsBehavioural
Dare to Care will provide meals each week for 12 weeks tailored for comorbidities. Meals will be provided to both the adult and the child(ren). Meals have been developed with a Registered Dietitian and have been approved through Food Is Medicine Coalition (FMIC). Meals are delivered via Door Dash each week.
Grocery PrescriptionBehavioural
Instacart Fresh Funds (for those that need delivery) or Kroger Grocery Rx cards will be issued to each participant per month to be spent on eligible healthy food items (lean protein, lean dairy, fruits, vegetables, eggs, and nuts). For each participating child in the household, they will receive additional funds/per child loaded on their grocery Rx card
Medically Tailored Meals and Grocery PrescriptionBehavioural
will receive both tailored MTM meals per week for adult and child(ren) and the GP monthly grocery funds
Nutritional CounselingBehavioural
30 minutes per week of nutrition counseling and assistance.
| Study group | Role | What they receive |
|---|---|---|
| MTM (medically tailored meals) | Active comparator | Fully prepared meals are delivered on a weekly basis, and tailored to specific health needs Receives: Behavioral: Medically Tailored Meals; Behavioral: Nutritional Counseling |
| GP (grocery prescription) | Active comparator | cards are issued to each participant per month to be spent on eligible healthy food items Receives: Behavioral: Grocery Prescription; Behavioral: Nutritional Counseling |
| MTM + GP (medically tailored meals and grocery prescription) | Active comparator | delivered weekly MTM meals and the GP monthly grocery funds Receives: Behavioral: Medically Tailored Meals and Grocery Prescription; Behavioral: Nutritional Counseling |
| Nutrition Counseling | Placebo comparator | 30 minutes per week of nutrition counseling and assistance. This group will receive the Grocery Prescription package after the last set of study measures are completed Receives: Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index (BMI) percentile - child
BMI percentile is automatically calculated in the Electronic Health Record (EHR) from height and weight using age- and gender-specific CDC growth charts
Measured: Baseline, post intervention (week 12), and month 6
Change in body mass index percentile - adult
BMI percentile is automatically calculated in the Electronic Health Record from height and weight
Measured: Baseline, post intervention (week 12), and month 6
Change in systolic blood pressure - child
blood pressure measurements will be taken from the electronic health record
Measured: Baseline, post intervention (week 12), and month 6
Change in diastolic blood pressure - child
blood pressure measurements will be taken from the electronic health record
Measured: Baseline, post intervention (week 12), and month 6
Change in systolic blood pressure - adult
blood pressure measurements will be taken from the electronic health record
Measured: Baseline, post intervention (week 12), and month 6
Change in diastolic blood pressure - adult
blood pressure measurements will be taken from the electronic health record
Measured: Baseline, post intervention (week 12), and month 6
Change in Hemoglobin A1c - child
A1c measures are collected at the clinic or affiliated lab and entered into the patient's EHR
Measured: Baseline, post intervention (week 12), and month 6
Change in Hemoglobin A1c - adult
A1c measures are collected at the clinic or affiliated lab and entered into the patient's EHR
Measured: Baseline, post intervention (week 12), and month 6
Change in total cholesterol - child
data will be pulled from the EHR
Measured: Baseline, post intervention (week 12), and month 6
Change in total cholesterol - adult
data will be pulled from the EHR
Measured: Baseline, post intervention (week 12), and month 6
Change in high-density lipoprotein (HDL) - child
data will be pulled from the EHR
Measured: Baseline, post intervention (week 12), and month 6
Change in high-density lipoprotein (HDL) - adult
data will be pulled from the EHR
Measured: Baseline, post intervention (week 12), and month 6
Change in low-density lipoprotein (LDL) - child
data will be pulled from the EHR
Measured: Baseline, post intervention (week 12), and month 6
Change in low-density lipoprotein (LDL) - adult
data will be pulled from the EHR
Measured: Baseline, post intervention (week 12), and month 6
Secondary outcomes (4)
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, post intervention (week 12), and month 6
Change in Family Stress
Anxiety and depression are measured using the Patient Health Questionnaire-4 (PHQ-4), a widely used and validated instrument. The PHQ-4 consists of a 2-question anxiety subscale and a 2-question depression subscale. For the anxiety subscale, respondents indicate how often, during the last 2 weeks, they have been bothered by the following: (1) feeling nervous, anxious, or on edge and (2) not being able to stop or control worrying. For the depression subscale, respondents indicate how often they have been bothered by the following: (1) little interest or pleasure in doing things and (2) feeling down, depressed, or hopeless. Response options for all four questions are as follows: not at all (0), several days (1), more than half the days (2), and nearly every day (3). For each of the subscales, zero is the minimum and a score of
‡ 3 is considered positive for screening purposes
Measured: Baseline, post intervention (week 12), and month 6
Change in Nutrition Security
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
Measured: Baseline, post intervention (week 12), and month 6
Change in Food Security
USDA 6-item food insecurity survey which can be found at this link https://www.ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/survey-tools Scores range from 0-6 with higher scores equating to lower food security
Measured: Baseline, post intervention (week 12), and month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Apr 2025
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized trial with a 2x2 design and a delayed control comparison group.
- Masking
- None (open label)
- Enrolment
- 56 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
- NCT06784310
- Sponsor's protocol ID
- 96706
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding the Family: Nutrition Security Intervention to Improve Physical and Mental Health Among Low-resource Families
- ClinicalTrials.gov ID
- NCT06784310
- Acronym / sponsor ID
- 96706
- Keywords
- Food as medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Alison GustafsonUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Food is Medicine for the whole will test an intervention which provides medically tailored meals, or grocery voucher cards, or a combination of these food and nutrition resources to a caregiver and children living in the household. The study will examine how providing healthy tailored food and nutrition services can improve health outcomes, such as blood pressure and cholesterol levels.
Detailed description
The proposal addresses the key goals of Humana Foundation related to, "Effective and equitable interventions to increase access to healthy diets promoting physical \& mental health benefits". The interdisciplinary team comprised of clinicians, researchers in public health, nutrition, mental health, and community partners will evaluate the effectiveness of a whole family nutrition security intervention to provide evidence supporting key policies on reimbursement of health-related social needs (HRSN) as a medically covered benefit. The study team will use a user-centered approach to examine how to engage the whole family in the short-term, while creating a sustainable model for clinic and community partnerships to use in the long-term. This proposal aims to answer the question "How can a food as medicine choice model with tailored dose improve health outcomes across the family?". To answer this question, investigators are proposing a pragmatic randomized control trial (pRCT) using a 2X2 factorial design among Medicaid families, adults with children ages 5-18, with an adult diagnosed with either hypertension or Type 2 Diabetes (T2DM), child has a BMI categorized as obese or overweight, and report being food insecure. The pRCT will take place in Louisville, Kentucky with University of Louisville Health as the clinic provider, in an urban setting with a high percentage of adults reporting race/ethnicity as Black or African American. The community partners are Dare to Care Food Bank as the medically tailored meal (MTM) provider, and Kroger Health/Soda Health as the grocery prescription provider (GP).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A randomized trial with a 2x2 design and a delayed control comparison group.
| Arm | Type | Receives |
|---|---|---|
| MTM (medically tailored meals) | Active comparator | Behavioral: Medically Tailored Meals, Behavioral: Nutritional CounselingFully prepared meals are delivered on a weekly basis, and tailored to specific health needs |
| GP (grocery prescription) | Active comparator | Behavioral: Grocery Prescription, Behavioral: Nutritional Counselingcards are issued to each participant per month to be spent on eligible healthy food items |
| MTM + GP (medically tailored meals and grocery prescription) | Active comparator | Behavioral: Medically Tailored Meals and Grocery Prescription, Behavioral: Nutritional Counselingdelivered weekly MTM meals and the GP monthly grocery funds |
| Nutrition Counseling | Placebo comparator | Behavioral: Nutritional Counseling30 minutes per week of nutrition counseling and assistance. This group will receive the Grocery Prescription package after the last set of study measures are completed |
Who may qualify
- Ages
- 6 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Have at least one child ages 6-17, inclusive, living in the household with the adult at least 50% of the time
- Diagnosis of stage 3 or 4 Hypertension in last 12 months, or diagnosis of T2DM in the last 12 months
- Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
- English speaking
- No plans to move from the area for at least 1 year
Key exclusion criteria (10 listed)
- Participant in diabetes, nutrition, or 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 |
|---|---|---|
| Medically Tailored MealsDare to Care will provide meals each week for 12 weeks tailored for comorbidities. Meals will be provided to both the adult and the child(ren). Meals have been developed with a Registered Dietitian and have been approved through Food Is Medicine Coalition (FMIC). Meals are delivered via Door Dash each week. | Behavioural | MTM (medically tailored meals) |
| Grocery PrescriptionInstacart Fresh Funds (for those that need delivery) or Kroger Grocery Rx cards will be issued to each participant per month to be spent on eligible healthy food items (lean protein, lean dairy, fruits, vegetables, eggs, and nuts). For each participating child in the household, they will receive additional funds/per child loaded on their grocery Rx card | Behavioural | GP (grocery prescription) |
| Medically Tailored Meals and Grocery Prescriptionwill receive both tailored MTM meals per week for adult and child(ren) and the GP monthly grocery funds | Behavioural | MTM + GP (medically tailored meals and grocery prescription) |
| Nutritional Counseling30 minutes per week of nutrition counseling and assistance. | Behavioural | GP (grocery prescription), MTM (medically tailored meals), MTM + GP (medically tailored meals and grocery prescription), Nutrition Counseling |
Primary outcome
Change in body mass index (BMI) percentile - child
Time frame: Baseline, post intervention (week 12), and month 6
BMI percentile is automatically calculated in the Electronic Health Record (EHR) from height and weight using age- and gender-specific CDC growth charts
Change in body mass index percentile - adult
Time frame: Baseline, post intervention (week 12), and month 6
BMI percentile is automatically calculated in the Electronic Health Record from height and weight
Change in systolic blood pressure - child
Time frame: Baseline, post intervention (week 12), and month 6
blood pressure measurements will be taken from the electronic health record
Change in diastolic blood pressure - child
Time frame: Baseline, post intervention (week 12), and month 6
blood pressure measurements will be taken from the electronic health record
Change in systolic blood pressure - adult
Time frame: Baseline, post intervention (week 12), and month 6
blood pressure measurements will be taken from the electronic health record
Change in diastolic blood pressure - adult
Time frame: Baseline, post intervention (week 12), and month 6
blood pressure measurements will be taken from the electronic health record
Change in Hemoglobin A1c - child
Time frame: Baseline, post intervention (week 12), and month 6
A1c measures are collected at the clinic or affiliated lab and entered into the patient's EHR
Change in Hemoglobin A1c - adult
Time frame: Baseline, post intervention (week 12), and month 6
A1c measures are collected at the clinic or affiliated lab and entered into the patient's EHR
Change in total cholesterol - child
Time frame: Baseline, post intervention (week 12), and month 6
data will be pulled from the EHR
Change in total cholesterol - adult
Time frame: Baseline, post intervention (week 12), and month 6
data will be pulled from the EHR
Change in high-density lipoprotein (HDL) - child
Time frame: Baseline, post intervention (week 12), and month 6
data will be pulled from the EHR
Change in high-density lipoprotein (HDL) - adult
Time frame: Baseline, post intervention (week 12), and month 6
data will be pulled from the EHR
Change in low-density lipoprotein (LDL) - child
Time frame: Baseline, post intervention (week 12), and month 6
data will be pulled from the EHR
Change in low-density lipoprotein (LDL) - adult
Time frame: Baseline, post intervention (week 12), and month 6
data will be pulled from the EHR
4 secondary outcomes
Change in Dietary Intake
Time frame: Baseline, post intervention (week 12), and month 6
Change in Family Stress
Time frame: Baseline, post intervention (week 12), and month 6
Change in Nutrition Security
Time frame: Baseline, post intervention (week 12), and month 6
Change in Food Security
Time frame: Baseline, post intervention (week 12), and month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 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 Medically Tailored Meals, Grocery Prescription and Medically Tailored Meals and Grocery Prescription in people with Food Insecurity and Type 2 Diabetes Mellitus (T2DM), 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 8 inclusion and 10 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 16 Mar 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in body mass index (BMI) percentile - child (time frame: Baseline, post intervention (week 12), and month 6). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2026.