Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Intervention delivery will include weekly virtual motivational interview sessions with a trained health coach."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
The GEM Study tests whether an online program to support healthy weight gain during pregnancy is practical and well-liked. It is for pregnant women with overweight or obesity. Everyone who joins gets weekly video coaching, tracks weight, steps, and blood sugar, and gets food and activity guidance.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For Phase 2: pregnant and less than 20 weeks along at screening.
- Age 18–45.
- Body mass index (BMI), a measure based on height and weight, of 25–40.
- Expecting one baby.
- Have a smartphone and/or reliable internet access.
- Willing for other people in the study to know who you are.
- Phase 1 seeks input from people who are pregnant or were pregnant in the past 36 months, and community partners with relevant views.
Who can't join
- For Phase 2: you smoke.
- Have a health condition that pregnancy could worsen, such as diabetes, long-term kidney failure, high blood pressure, cancer, seizures, lupus, drug or alcohol abuse, or a serious mental illness.
- Have a current mental health condition or eating disorder.
- Cannot exercise safely. Approval from your pregnancy doctor is needed before you agree to join.
- Became pregnant with fertility treatments.
- Take medicines during pregnancy known to affect the baby's growth, such as thyroid hormone, certain steroids, insulin, or blood sugar pills.
- Plan to move out of the state within 6 months after screening.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
AR
- Arkansas Children's Research Institute - Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences · Little Rock, AR 72205Elizabeth Hayes, Recruitment Coordinator · Study contact · 501-364-3309 · ACNCStudies@uams.eduLisa T Jansen, PhD · Principal investigatorMore trials in Little Rock