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

Sponsor
Arkansas Children's Hospital Research Institute (Academic or other)
Enrollment
16 planned
Conditions
Pregnancies at Increased Risk for Excessive Gestational Weight Gain; Ecological Momentary Assessment and Intervention; Continuous Glucose Monitor
Interventions
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy
Ages
adults
Registry
NCT06666257

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention
  • Feasibility data of the modified EMI: SmartMomsAR - Acceptability
  • Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered