Adaptive program to improve food access and maternal and child health during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot, single-site interventional study using an adaptive approach to allocate food-security supports to pregnant people who screen positive for food insecurity. Participants in early pregnancy will be randomized or adaptively assigned to receive one of several interventions, including electronic WIC referral, WIC referral plus care navigation, produce prescriptions, or medically tailored meals. The primary focus is feasibility: can the team recruit and retain participants and deliver the adaptive intervention as planned in preparation for a larger definitive trial. Outcomes will include measures of food security, participation rates, and implementation metrics rather than definitive clinical endpoints.

Why it matters

Who can join: the full rules

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)

Where it's running

• Wake Forest University Health Sciences
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Deepak Palakshappa, MD, MSHP — Wake Forest University Health Sciences
• Study coordinator: Deepak Palakshappa, MD, MSHP
• Email: deepak.palakshappa@wfusm.edu
• Phone: 336-716-1795

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.