Food Insecurity, Social Determinants of Health

Completed · Not applicable

Conditions studied: Food Insecurity, Type 2 Diabetes Mellitus (T2DM), Hypertension

In brief

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.

Key facts

Study ID

NCT06784310

Run by

Alison Gustafson

People needed

56

Starts

2025-04-01

Expected to finish

2026-03-05

Last updated by the study team

2026-03-16

Who can join

Age: 6 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UofL Health — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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