Food Insecurity, Social Determinants of Health

Last updated: November 17, 2025
Sponsor: Alison Gustafson
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vascular Diseases

Stress

Williams Syndrome

Treatment

Medically Tailored Meals

Grocery Prescription

Nutritional Counseling

Clinical Study ID

NCT06784310
96706
  • Ages 6-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have at least one child ages 6-17, inclusive, living in the household with the adultat least 50% of the time

  • Diagnosis of stage 3 or 4 Hypertension in last 12 months, or diagnosis of T2DM inthe 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 studyactivities.

Exclusion

Exclusion Criteria:

  • Participant in diabetes, nutrition, or weight research intervention in last 12months

  • 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 ormedically 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 studyactivities

  • Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that arelikely to affect blood sugar.

Study Design

Total Participants: 85
Treatment Group(s): 4
Primary Treatment: Medically Tailored Meals
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
June 30, 2026

Study 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).

Connect with a study center

  • UofL Health

    Louisville, Kentucky 40211
    United States

    Site Not Available

  • UofL Health

    Louisville 4299276, Kentucky 6254925 40211
    United States

    Site Not Available

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