Back to search results

Study on Food Security and Maternal-Child Health in Pregnant Individuals

This study is looking at different ways to help pregnant individuals who are experiencing food insecurity (not having reliable access to enough affordable, nutritious food). Food insecurity can lead to health problems for both the pregnant person and their baby. The study will test several interventions: a produce prescription (weekly fruit and vegetable delivery), medically tailored meals (weekly prepared meals designed by a dietitian), an electronic health record WIC referral (connecting you to the WIC program), or an electronic health record WIC referral plus care navigation (with extra support to access WIC). Researchers want to see how easy it is to find and keep participants, and to offer these different types of support. You may be able to join if you are at least 18 years old, have a confirmed pregnancy, experience food insecurity, speak English or Spanish, are not currently enrolled in WIC, and are in your first trimester.

Study design
This is an interventional study planning to enroll 60 participants. It will test different behavioral interventions to address food insecurity.
What's involved
Participants in the produce prescription or medically tailored meals groups will receive weekly deliveries for 3 months. The study aims to measure retention up to 6 months.
Compensation
Not stated in the trial record.
Follow-up
The study aims to measure participant retention up to 6 months after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06942598

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

Recruiting
NAAges 18+InterventionalHealth services
Wake Forest University Health Sciences
~60 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Produce prescriptionMedically tailored mealsElectronic health record WIC referralElectronic health record WIC referral + care navigation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of recruitment - Proportion of eligible patients who enroll
Measured over Baseline
+3 more outcomes measured

Conditions

Food Insecurity
Pregnancy

Explore related trials

Food InsecurityPregnancy

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Deepak Palakshappa, MD, MSHP · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Deepak Palakshappa, MD, MSHP
[email protected]
336-716-1795
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

≥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

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)

What this trial measures

  • Feasibility of recruitment - Proportion of eligible patients who enrollBaseline

    Proportion of eligible patients who enroll in the study based on study logs

  • Feasibility of retention - Proportion of eligible participantsMonth 6

    The proportion of eligible participants who complete 3-month and 6-month follow-up data collection based on study log

  • Feasibility of re-randomization - Proportion of eligible participantsMonth 3

    The proportion of eligible participants who are re-randomized to a stage 2 intervention based on study log.

  • Food insecurity ScoresMonth 6

    Survey participants using the validated 10-item USDA Adult FSSM, with a 30-day look back period. The tool measures food security over the prior 30 days. Using the standardized scoring provided by the USDA to assess participants responses. This produces a raw score that ranges from 0 to 10 with higher scores indicating worse FI. High Food Security: Raw score of 0. Marginal Food Security: Raw score of 1-2. Low Food Security: Raw score of 3-5. Very Low Food Security: Raw score of 6-1