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Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study

Study acronym: GEM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Apr 30, 2026 → Jul 30, 2027
See other at-risk trials from Arkansas Children's Hospital Research Institute

Record History

  1. Primary completion pushed from Apr 30, 2026 to Jul 30, 2027 Recruitment opened · Lead sponsor: Arkansas Children's Hospital Research Institute to Arkansas Children's Hospital Research Institute · Completion pushed from Jul 30, 2026 to Sep 30, 2027 · 5 more Show 8 more changesShow less
    • Recruitment opened
    • Lead sponsor: Arkansas Children's Hospital Research Institute to Arkansas Children's Hospital Research Institute
    • Completion pushed from Jul 30, 2026 to Sep 30, 2027
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2025 to Mar 1, 2025
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description revised
  2. Enrollment target: 44 to 16 Start date: May 1, 2025 to Oct 1, 2025 · Primary endpoints revised (3) · Completion date: Apr 30, 2026 to Jul 30, 2026 · 5 morev3 Show 8 more changesShow less
    • Start date: May 1, 2025 to Oct 1, 2025
    • Primary endpoints revised (3)
    • Completion date: Apr 30, 2026 to Jul 30, 2026
    • Interventions: Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy (Behavioral), E-Monitoring to Support Healthy Weight Gain… to Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy (Behavioral)
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 28 words
    • Study arms: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Nov 1, 2024 to May 1, 2025v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This single-arm pilot study will evaluate the feasibility and acceptability of a remotely delivered behavioral lifestyle intervention, adapted from the SmartMoms framework, to promote health gestational weight gain in pregnant women with overweight and obesity. Twelve to sixteen participants will receive weekly virtual motivational interview sessions with trained health coaches, review their daily weight data, step count, and continuous glucose monitoring data, and tailored guidance on physical activity and nutrition. Educational content will be delivered electronically, with peer support provided through a closed online group. A simulated (mock) control arm will be created post hoc from existing records for preliminary comparisons; all enrolled participants will receive the intervention.
Trial Details
NCT Number NCT06666257
Lead Sponsor Arkansas Children's Hospital Research Institute
Collaborators: National Institute of General Medical Sciences (NIGMS)
Conditions Pregnancies at Increased Risk for Excessive Gestational Weight Gain, Ecological Momentary Assessment and Intervention, Continuous Glucose Monitor
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov