Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
Recruiting now · Not applicable
Conditions studied: Food Insecurity, Pregnancy
In brief
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.
Key facts
- Study ID
- NCT06942598
- Run by
- Wake Forest University Health Sciences
- People needed
- 60
- Starts
- 2025-06-17
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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)
Where it is running
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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