Providing tailored meals and nutrition support to families facing food insecurity
Feeding the Family: Nutrition Security Intervention to Improve Physical and Mental Health Among Low-resource Families
This study is testing whether providing customized meals and nutrition help to families with kids who are facing food insecurity can improve health for adults with high blood pressure or diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 6 Years to 64 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06784310 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on addressing food insecurity by providing medically tailored meals, grocery vouchers, and nutritional counseling to families with children aged 5-18. The study aims to evaluate the effectiveness of these resources in improving health outcomes, particularly for adults diagnosed with hypertension or Type 2 Diabetes Mellitus. Utilizing a pragmatic randomized control trial design, the research will engage families in a user-centered approach while establishing sustainable community partnerships. The trial will take place in Louisville, Kentucky, targeting Medicaid families experiencing food insecurity.
Who should consider this trial
Good fit: Ideal candidates include Medicaid families with at least one child aged 5-18, where an adult has hypertension or Type 2 Diabetes and the family is experiencing food insecurity.
Not a fit: Patients who are not experiencing food insecurity or do not have a child living in the household may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for families dealing with food insecurity and chronic health conditions.
How similar studies have performed: Other studies have shown promise in using food as medicine approaches, indicating potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Louisville, Kentucky
- UofL Health — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Alison Gustafson, PhD, MPH, RD — University of Kentucky
- Study coordinator: Alison Gustafson, PhD, MPH, RD
- Email: christa.mayfield@uky.edu
- Phone: alison.gustafson@uky.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.