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

Wake Forest University Health Sciences · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT06942598

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
June 17, 2025
Record last updated
October 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Produce prescription; Medically tailored meals; Electronic health record WIC referral; Electronic health record WIC referral + care navigation

Conditions: Food Insecurity; Pregnancy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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)

Recruiting US locations

  • Wake Forest University Health Sciences

    Winston-Salem, NC 27157

    Site contact: Deepak Palakshappa, MD, MSHP · 336-716-1795 · dpalaksh@wakehealth.edu

Study contacts (from the official record)

  • Deepak Palakshappa, MD, MSHP · 336-716-1795 · deepak.palakshappa@wfusm.edu
  • Rebecca Stone, MPH · 336-713-5544 · rebecca.j.stone@advocatehealth.org
All nutrition & metabolism studies in North Carolina →
Feasibility of an ADAPTive Intervention to Improve Food Security… (NCT06942598) | Bored Studies