Food Insecurity, Social Determinants of Health

Not Applicable

Recruiting

• Conditions: Food Insecurity; Type 2 Diabetes Mellitus (T2DM); Hypertension

• Registration Number: NCT06784310
• Lead Sponsor: Alison Gustafson

Brief 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. 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 Timeline

• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-04-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2026-02-28
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in body mass index (BMI) percentile - child	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	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	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	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	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	Baseline, post intervention (week 12), and month 6	blood pressure measurements will be taken from the electronic health record
Change in Hemoglobin A1c - child	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	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	Baseline, post intervention (week 12), and month 6	data will be pulled from the EHR
Change in total cholesterol - adult	Baseline, post intervention (week 12), and month 6	data will be pulled from the EHR
Change in high-density lipoprotein (HDL) - child	Baseline, post intervention (week 12), and month 6	data will be pulled from the EHR
Change in high-density lipoprotein (HDL) - adult	Baseline, post intervention (week 12), and month 6	data will be pulled from the EHR
Change in low-density lipoprotein (LDL) - child	Baseline, post intervention (week 12), and month 6	data will be pulled from the EHR
Change in low-density lipoprotein (LDL) - adult	Baseline, post intervention (week 12), and month 6	data will be pulled from the EHR

Secondary Outcome Measures

Name	Time	Method
Change in Dietary Intake	Baseline, post intervention (week 12), and month 6	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.
Change in Nutrition Security	Baseline, post intervention (week 12), and month 6	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
Change in Food Security	Baseline, post intervention (week 12), and month 6	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
Change in Family Stress	Baseline, post intervention (week 12), and month 6	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

Trial Locations

Locations (1)

UofL Health; 🇺🇸 Louisville, Kentucky, United States