Food Insecurity, Social Determinants of Health

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Food Insecurity; Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: Medically Tailored Meals; Behavioral: Nutritional Counseling; Behavioral: Grocery Prescription; Behavioral: Medically Tailored Meals and Grocery Prescription

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40211
      • UofL Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MTM (medically tailored meals); Fully prepared meals are delivered on a weekly basis, and tailored to specific health needs	Behavioral: Medically Tailored Meals; 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.; Behavioral: Nutritional Counseling; 30 minutes per week of nutrition counseling and assistance.
Active Comparator: GP (grocery prescription); cards are issued to each participant per month to be spent on eligible healthy food items	Behavioral: Nutritional Counseling; 30 minutes per week of nutrition counseling and assistance.; Behavioral: Grocery Prescription; 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
Active Comparator: MTM + GP (medically tailored meals and grocery prescription); delivered weekly MTM meals and the GP monthly grocery funds	Behavioral: Nutritional Counseling; 30 minutes per week of nutrition counseling and assistance.; Behavioral: Medically Tailored Meals and Grocery Prescription; will receive both tailored MTM meals per week for adult and child(ren) and the GP monthly grocery funds
Placebo Comparator: Nutrition Counseling; 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	Behavioral: Nutritional Counseling; 30 minutes per week of nutrition counseling and assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Hemoglobin A1c - child	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 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
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

Secondary Outcome Measures

Outcome Measure	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.	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
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

Collaborators and Investigators

• Sponsor: Alison Gustafson
• Investigators: Principal Investigator: Alison Gustafson, PhD, MPH, RD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Actual): March 5, 2026
• Study Completion (Actual): March 5, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Food as medicine
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Epidemiologic Measurements; Nutrition Assessment
• Other Study ID Numbers: 96706

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No