RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06942598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * Confirmed viable pregnancy by their obstetrician or midwife based on urine pregnancy test and ultrasound
  3. * Experience Food Insecurity (FI) based on the 2-item Hunger Vital Sign
  4. * Speaks English or Spanish
  5. * Not currently enrolled in WIC
  6. * First trimester at the time of the initial prenatal visit
  1. * Planning on moving out of the area within 6 months
  2. * 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)
  3. * Lack safe, stable residence or the ability to store the medically tailored meals (MTM)
  4. * Lack of a telephone
  5. * Severe food allergy or require a specialized diet (e.g., Celiac)

Contacts and Locations

Study Contact

Deepak Palakshappa, MD, MSHP
CONTACT
336-716-1795
dpalaksh@wakehealth.edu
Rebecca Stone, MPH
CONTACT
336-713-5544
rjstone@wakehealth.edu

Principal Investigator

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

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2027-02

Study Record Updates

Study Start Date2025-06
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Supplemental Nutrition Program for Women/Infants/Children
  • Medically tailored meals
  • Fruits and vegetables

Additional Relevant MeSH Terms

  • Food Insecurity
  • Pregnancy