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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorArkansas Children's Hospital Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

Currently pregnant or pregnant within the past 36 months.

Community partners with relevant perspectives to inform recruitment, adaptation approaches and feasibility of the phase 2 pilot trial.

pregnant women less than 20 weeks of gestation at time of screening

18-45 years of age

Disqualifiers

Smoker

Preexisting medical conditions that might be exacerbated by pregnancy (e.g., diabetes mellitus, chronic renal failure, hypertension, malignancies, seizure disorder, lupus, drug or alcohol abuse, serious psychiatric disorders)

Current mental health or eating disorder

Contraindication to exercise (OB/GYN release is obtained prior to consent)

Trial design

Treatments tested in this trial

  • Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy

Treatment groups

16 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Arkansas Children's Hospital Research Institute

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator