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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
Summary
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.
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2025-10-01
Completion Date
2026-07-30
Last Updated
2025-08-15
Healthy Volunteers
No
Conditions
Interventions
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy
The intervention we are basing our adaptations on is a ecological momentary intervention, meaning it is integrated into participants daily lifestyle and schedule. Using an established framework for tracking daily body weight and physical activity, a gestational weight gain trajectory is estimated. Based on the data, recommendation prompts for exercise and diet will be discussed with participants during motivational interviewing. For the CGM piece, participants will wear unblinded CGM devices and have access to CGM linked app features that allow insights and reactivity to personal glycemic data