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

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.

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	2025-10-01
Primary Completion	2026-04-30 (estimated)
Study Completion	2026-07-30 (estimated)
Updated on ClinicalTrials.gov	2025-08-15