Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Who can join
Ages 18 to 45 · Women
Full eligibility criteria
The formative phase (Phase I), classified as exempt by the institutional review board will seek participation from individuals meeting the following criteria: 1. Currently pregnant or pregnant within the past 36 months. 2. Community partners with relevant perspectives to inform recruitment, adaptation approaches and feasibility of the phase 2 pilot trial. Clinical Trial (Phase 2) Inclusion Criteria: * 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 . Exclusion Criteria: * 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.
About the 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.
What is being tested
- Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy (behavioral)
Sponsor: Arkansas Children's Hospital Research Institute · Participants: 16 · Started: Mar 1, 2025
Contact the study team
- Lisa T Jansen, PhD · Phone: 5013646516
- Sharon E Sanders, PhD, MPH, CHES · Phone: 501-364-5118
Official record on ClinicalTrials.gov — NCT06666257
Locations in the U.S.
| Arkansas | Arkansas Children's Research Institute - Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.