Food Insecurity, Social Determinants of Health

NCT ID: NCT06784310

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-06-30

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MTM (medically tailored meals)

Fully prepared meals are delivered on a weekly basis, and tailored to specific health needs

Group Type: ACTIVE_COMPARATOR

Medically Tailored Meals

Intervention Type: 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.

Nutritional Counseling

Intervention Type: BEHAVIORAL

30 minutes per week of nutrition counseling and assistance.

GP (grocery prescription)

cards are issued to each participant per month to be spent on eligible healthy food items

Group Type: ACTIVE_COMPARATOR

Grocery Prescription

Intervention Type: 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

Nutritional Counseling

Intervention Type: BEHAVIORAL

30 minutes per week of nutrition counseling and assistance.

MTM + GP (medically tailored meals and grocery prescription)

delivered weekly MTM meals and the GP monthly grocery funds

Group Type: ACTIVE_COMPARATOR

Medically Tailored Meals and Grocery Prescription

Intervention Type: BEHAVIORAL

will receive both tailored MTM meals per week for adult and child(ren) and the GP monthly grocery funds

Nutritional Counseling

Intervention Type: BEHAVIORAL

30 minutes per week of nutrition counseling and assistance.

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

Group Type: PLACEBO_COMPARATOR

Nutritional Counseling

Intervention Type: BEHAVIORAL

30 minutes per week of nutrition counseling and assistance.

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Nutritional Counseling

30 minutes per week of nutrition counseling and assistance.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alison Gustafson

OTHER

Sponsor Role: lead

Responsible Party

Alison Gustafson

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alison Gustafson, PhD, MPH, RD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

UofL Health

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

96706

Identifier Type: -

Identifier Source: org_study_id