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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTM (medically tailored meals) | Active Comparator | Fully prepared meals are delivered on a weekly basis, and tailored to specific health needs |
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| GP (grocery prescription) | Active Comparator | cards are issued to each participant per month to be spent on eligible healthy food items |
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| MTM + GP (medically tailored meals and grocery prescription) | Active Comparator | delivered weekly MTM meals and the GP monthly grocery funds |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medically Tailored Meals | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Gustafson, PhD, MPH, RD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UofL Health | Louisville | Kentucky | 40211 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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A randomized trial with a 2x2 design and a delayed control comparison group.
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| Grocery Prescription | Behavioral | 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 |
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| Medically Tailored Meals and Grocery Prescription | Behavioral | will receive both tailored MTM meals per week for adult and child(ren) and the GP monthly grocery funds |
|
| Nutritional Counseling | Behavioral | 30 minutes per week of nutrition counseling and assistance. |
|
| 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 | Baseline, post intervention (week 12), and month 6 |
| Change in total cholesterol - child | data will be pulled from the EHR | Baseline, post intervention (week 12), and month 6 |
| Change in total cholesterol - adult | data will be pulled from the EHR | Baseline, post intervention (week 12), and month 6 |
| Change in high-density lipoprotein (HDL) - child | data will be pulled from the EHR | Baseline, post intervention (week 12), and month 6 |
| Change in high-density lipoprotein (HDL) - adult | data will be pulled from the EHR | Baseline, post intervention (week 12), and month 6 |
| Change in low-density lipoprotein (LDL) - child | data will be pulled from the EHR | Baseline, post intervention (week 12), and month 6 |
| Change in low-density lipoprotein (LDL) - adult | data will be pulled from the EHR | Baseline, post intervention (week 12), and month 6 |
| 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 | 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 | 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 | Baseline, post intervention (week 12), and month 6 |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |