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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

Qualifiers

≥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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Produce prescription
  • Medically tailored meals
  • Electronic health record WIC referral
  • Electronic health record WIC referral + care navigation

Treatment groups

60 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

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

Collaborator