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NOT YET RECRUITING
NCT06666257
NA

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

Sponsor: Arkansas Children's Hospital Research Institute

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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