Food Insecurity, Social Determinants of Health
Launched by ALISON GUSTAFSON · Jan 14, 2025
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, titled "Food is Medicine for the Whole," is exploring how providing healthy food options can help improve health for families facing challenges like food insecurity, high blood pressure, and type 2 diabetes. The study will offer participants either specially prepared meals, grocery vouchers, or a combination of both to see how these resources can positively impact health markers such as blood pressure and cholesterol levels.
To be eligible for this trial, you need to have at least one child aged 6 to 17 living with you most of the time, and you should have been diagnosed with high blood pressure (stage 3 or 4) or type 2 diabetes within the last year. You must also be experiencing food insecurity and be able to communicate in English. Participants will be asked to engage in study activities and will receive text messages about the study. It’s important to note that the trial is not open for recruitment yet, but if you meet the criteria, it could be an opportunity to receive support that might improve your family's health.
Gender
ALL
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.
About Alison Gustafson
Alison Gustafson is a dedicated clinical trial sponsor with a strong focus on advancing innovative healthcare solutions through rigorous research and development. With extensive experience in managing clinical trials across various therapeutic areas, Alison is committed to ensuring the integrity, safety, and efficacy of new treatments. Her leadership emphasizes collaboration with research institutions, regulatory bodies, and key stakeholders to facilitate the successful execution of trials, ultimately aiming to improve patient outcomes and contribute to the advancement of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Louisville, Kentucky, United States
Patients applied
Trial Officials
Alison Gustafson, PhD, MPH, RD
Principal Investigator
University of Kentucky
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported