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Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health

Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health (ADAPT-MCH)

Who can join

Ages 18 and older · Women · Healthy volunteers welcome

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)

About the study

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.

What is being tested

• Produce prescription (behavioral)
• Medically tailored meals (behavioral)
• Electronic health record WIC referral (behavioral)
• Electronic health record WIC referral + care navigation (behavioral)

Sponsor: Wake Forest University Health Sciences · Participants: 60 · Started: Jun 17, 2025

Contact the study team

• Deepak Palakshappa, MD, MSHP · Phone: 336-716-1795
• Rebecca Stone, MPH · Phone: 336-713-5544

Official record on ClinicalTrials.gov — NCT06942598

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.