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

Study acronym: ADAPT-MCH
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Nov 2026 → Aug 2027
See other at-risk trials from Wake Forest University Health Sciences

Record History

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  1. Primary completion pushed from Nov 2026 to Aug 2027 Show 5 more changesShow less
    • Study completion pushed from Feb 2027 to Nov 2027
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 10 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Interventions: Medically tailored meals (Behavioral), Produce prescription (Behavioral) to Electronic health record WIC referral (Behavioral), Electronic health record WIC referral + care navigation (Behavioral), Medically…
    • Study arms: 2 to 4
    v5
  3. Start date changed from estimate of Jun 2025 to Jun 17, 2025v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 2025 to Nov 2026
    • Site details revised
    v3
  5. Start date: May 2025 to Jun 2025v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06942598
Lead Sponsor Wake Forest University Health Sciences
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Food Insecurity, Pregnancy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov