ClinConnect ClinConnect Logo
Search / Trial NCT06942598

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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 16, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Supplemental Nutrition Program For Women/Infants/Children Medically Tailored Meals Fruits And Vegetables

ClinConnect Summary

This clinical trial is exploring ways to help pregnant individuals who struggle with food insecurity, which means they may not have enough access to nutritious food. Food insecurity can lead to serious health problems for both the mother and the baby, such as an increased risk of diabetes and premature birth. The goal of this study is to find out how well different support programs can be tailored to meet the unique needs of pregnant women facing food challenges. By doing this, the researchers hope to develop a program that can effectively improve food security and overall health for mothers and their children.

To participate in this trial, individuals must be at least 18 years old, have a confirmed pregnancy, and experience food insecurity based on specific questions about hunger. They should also be in their first trimester of pregnancy and speak either English or Spanish. Participants will receive support for food insecurity, and the study will help researchers understand how to best provide this support in the future. It’s important to note that individuals who have certain health conditions, severe food allergies, or who are planning to move out of the area soon may not be eligible to join.

Gender

FEMALE

Eligibility 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)

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Deepak Palakshappa, MD, MSHP

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported