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NCT06942598
Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
Conditions: Food Insecurity, Pregnancy
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Wake Forest University Health Sciences
Location: Wake Forest University Health Sciences Winston-Salem North Carolina
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 cardiometabolic chronic conditions (e.g., type 2 diabetes and obesity). Interventions are being utilized to address food insecurity in clinical care settings, but patients differ in the support needed to reduce food insecurity and health systems have limited resources to invest in these interventions. Rather than a single intervention, adaptively allocating interventions could be a more effective, equitable, and efficient approach to improve food security; the objectives of this pilot study are to determine the feasibility of recruiting, retaining, and adaptively providing food insecurity interventions to pregnant patients in anticipation of a large, definitive trial in the future.
Eligibility Criteria
Inclusion Criteria:
* ≥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 Criteria:
* 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)
Source: ClinicalTrials.gov (NCT06942598). StuddyBuddy aggregates publicly available trial information.