Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Eligible age
18–45 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this 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.
Sponsor: Arkansas Children's Hospital Research Institute
You may qualify if…
- ✓ pregnant women less than 20 weeks of gestation at time of screening
- ✓ 18-45 years of age
- ✓ BMI of 25 - 40 kg/m-2
- ✓ Expecting a singleton pregnancy
- ✓ Smartphone and/or reliable internet access
- ✓ Willing to be identifiable to other study participants in the study program .
You may not qualify if…
- ✕ 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)
- ✕ Conceived with assisted fertility treatments
- ✕ Medications during pregnancy known to influence fetal growth (e.g., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents)
- ✕ Plans to move out of the state in the next 6 months following screening.
Where it's recruiting
Little Rock
Source: ClinicalTrials.gov · NCT06666257 · last updated 2026-10-09