What is this study trying to find out about food insecurity and pregnancy?

This study is evaluating different ways to provide support to pregnant people who experience food insecurity to improve their health and their babies' health. Researchers want to see if it is possible to recruit and keep participants in the study while offering various food support programs. The study is sponsored by Wake Forest University Health Sciences and aims to inform a larger future trial.

Who may be eligible for this food insecurity and pregnancy clinical trial?

Women aged 18 years or older who are pregnant with a confirmed viable pregnancy and experience food insecurity may be eligible. Participants must speak English or Spanish and not currently be enrolled in WIC. They must be in their first trimester at their initial prenatal visit. Please review eligibility criteria for more details.

Is there any cost to participate in this food insecurity and pregnancy clinical trial?

Study-related care, including the study interventions and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for their visit-related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

FEMALE

Healthy Volunteers

ID06942598

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

Led by Wake Forest University Health Sciences · Updated on 2026-03-03

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Food insecurity affects nearly 30 of pregnancies and is linked to poorer health outcomes for pregnant individuals and their children, including higher risks of gestational diabetes, preterm birth, and long-term chronic conditions like type 2 diabetes and obesity. This research aims to test the feasibility of recruiting, retaining, and adaptively providing food insecurity interventions to pregnant patients, paving the way for a larger future trial. The study responds to the increasing rates of maternal mortality in the US, much of which is related to nutrition-related chronic diseases and food insecurity during pregnancy. Participants will be randomly assigned to one of four groups referral to the Women, Infants and Children WIC program via electronic health record electronic WIC referral plus care navigation with personalized support weekly produce deliveries worth 10 for three months or weekly deliveries of medically tailored meals planned by a dietitian, also for three months. The study includes a care navigator who helps some participants overcome barriers to accessing WIC and connects them with community resources. All interventions aim to address food insecurity in pregnancy through different supportive approaches. Participants will be followed over several months with assessments at enrollment, three months, and six months. Researchers will measure recruitment and retention rates, changes in food insecurity scores, and health outcomes such as gestational diabetes, gestational weight gain, pre-eclampsia, and infant birth outcomes. Adherence to meal plans and use of community resources will be tracked. The study includes safety and follow-up monitoring to evaluate the feasibility and impact of these adaptive food insecurity interventions during pregnancy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

FEMALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

18 years of age or older
Confirmed viable pregnancy by urine pregnancy test and ultrasound
Experience food insecurity based on the 2-item Hunger Vital Sign
Speaks English or Spanish
Not currently enrolled in Women, Infants and Children (WIC) program
In first trimester at the initial prenatal visit

You will not qualify if you...

Planning to move out of the area within 6 months
Severe cognitive impairment or major psychiatric illness preventing consent
Serious medical condition limiting life expectancy or requiring active management
Lack of safe, stable residence or unable to store medically tailored meals
Lack of a telephone
Severe food allergy or need for a specialized diet such as for Celiac disease

Research Team

Deepak Palakshappa, MD, MSHP

Rebecca Stone, MPH

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