Status:
RECRUITING
Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Food Insecurity
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Food insecurity affects up to 30% of pregnancies and leads to worse health in pregnant people and their children, including an increased risk of gestational diabetes, pre-term birth, and future cardio...
Detailed Description
The US is facing a maternal and infant health crisis. Each year in the US there are \>700 maternal deaths and \>60,000 life-threatening pregnancy events. Despite decreasing in other high-income countr...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Confirmed viable pregnancy by their obstetrician or midwife based on urine pregnancy test and ultrasound
- Experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
- Speaks English or Spanish
- Not currently enrolled in WIC
- First trimester at the time of the initial prenatal visit
Exclusion
- Planning on moving out of the area within 6 months
- Severe cognitive impairment or major psychiatric illness that prevents consent or serious medical condition which either limits life expectancy or requires active management (e.g., certain cancers)
- Lack safe, stable residence or the ability to store the medically tailored meals (MTM)
- Lack of a telephone
- Severe food allergy or require a specialized diet (e.g., Celiac)
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06942598
Start Date
June 17 2025
End Date
February 1 2027
Last Update
June 27 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157