NCT06666257Recruiting
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 22 Oct 2024
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Jul 2027
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Diseases
- Obesity
- NCT number
- NCT06666257
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 1 Mar 2025 to the primary completion date, 30 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- Smoker
- Conceived with assisted fertility treatments
- Plans to move out of the state in the next 6 months following screening.
Who the study is looking for
- 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 .
Criteria the registry did not label
- 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)
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arkansas Children's Research Institute - Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.