NCT06784310

Food Insecurity, Social Determinants of Health

Feeding the Family: Nutrition Security Intervention to Improve Physical and Mental Health Among Low-resource Families

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Alison Gustafson · Academic / Other
• Sex: All
• Age: 6 Years – 64 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Food Insecurity
• Type 2 Diabetes Mellitus (T2DM)
• Hypertension

Interventions

Type	Name	Description
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	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
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
BEHAVIORAL	Nutritional Counseling	30 minutes per week of nutrition counseling and assistance.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-03-05
• Completion: 2026-03-05
• First posted: 2025-01-20
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States