Adaptive program to improve food access and maternal and child health during pregnancy
Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health (ADAPT-MCH)
This pilot will test whether giving food-insecure pregnant people different supports—like WIC referrals, produce prescriptions, or medically tailored meals—based on their needs helps improve food access and health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06942598 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people aged 18 or older in their first trimester of a viable pregnancy, who speak English or Spanish, are not currently enrolled in WIC, and screen positive for food insecurity on the 2-item Hunger Vital Sign.
Not a fit: People planning to move away within six months, lacking safe storage for meals, with severe food allergies or specialized diets, without a telephone, or already enrolled in WIC are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could help pregnant people get the right food support at the right time, improving nutrition and lowering risks linked to food insecurity such as gestational diabetes and poor birth outcomes.
How similar studies have performed: Individual interventions like produce prescriptions, medically tailored meals, and WIC support have shown improvements in diet and food access in other settings, but using an adaptive allocation strategy in pregnancy is largely untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.