Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06942598

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

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

60

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Food insecurity affects up to 30% of pregnancies and leads to worse health in pregnant people and their children, including an increased risk of gestational diabetes, pre-term birth, and future cardiometabolic chronic conditions (e.g., type 2 diabetes and obesity). Interventions are being utilized to address food insecurity in clinical care settings, but patients differ in the support needed to reduce food insecurity and health systems have limited resources to invest in these interventions. Rather than a single intervention, adaptively allocating interventions could be a more effective, equitable, and efficient approach to improve food security; the objectives of this pilot study are to determine the feasibility of recruiting, retaining, and adaptively providing food insecurity interventions to pregnant patients in anticipation of a large, definitive trial in the future.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Confirmed viable pregnancy by obstetrician or midwife using urine pregnancy test and ultrasound
  • Experience food insecurity based on the 2-item Hunger Vital Sign
  • Speaks English or Spanish
  • Not currently enrolled in WIC
  • In first trimester at the time of initial prenatal visit
Not Eligible

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 (e.g., certain cancers)
  • Lack of safe, stable residence or inability to store medically tailored meals
  • Lack of a telephone
  • Severe food allergy or need for a specialized diet (e.g., Celiac)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

Loading map...

Research Team

D

Deepak Palakshappa, MD, MSHP

CONTACT

R

Rebecca Stone, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here