Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Key facts
- Where
- Little Rock, Egyesült ÁllamokSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Where in Egyesült Államok
- Arkansas Children's Research Institute - Arkansas Children's Nutrition Center, University of Arkansas for Medical SciencesLittle Rock, Egyesült ÁllamokTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Arkansas Children's Hospital Research Institute
- Trial code
- NCT06666257
- Record updated
- 2026. október 9.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Contraindication to exercise (OB/GYN release is obtained prior to consent); Medications during pregnancy known to influence fetal growth (e.g., thyroid hormone, glucocorticoids, insulin, oral hypoglycemic agents); 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; Smoker; Conceived with assisted fertility treatments; Plans to move out of the state in the next 6 months following screening.
The formative phase (Phase I), classified as exempt by the institutional review board will seek participation from individuals meeting the following criteria:; 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; Clinical Trial (Phase 2).