Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study

Launched by ARKANSAS CHILDREN'S HOSPITAL RESEARCH INSTITUTE · Oct 28, 2024

Keywords

ClinConnect Summary

The GEM Study is a clinical trial designed to help pregnant women who are at risk of gaining too much weight during pregnancy. Specifically, the researchers want to see how well a Continuous Glucose Monitor (CGM) can work as a tool for self-monitoring alongside an existing program called SmartMoms, which provides support and information to pregnant women. This study involves two phases: the first phase gathers feedback from participants about the SmartMoms program and the CGM, while the second phase will involve pregnant women who are less than 14 weeks along. Participants will be placed in one of two groups: one will use the regular SmartMoms program, and the other will use SmartMoms along with the CGM.

To be eligible for this study, women must be between 18 and 45 years old, have a body mass index (BMI) between 25 and 40, and be expecting a single baby. They will also need to have a smartphone or reliable internet access. However, women with certain health conditions, including diabetes or serious mental health issues, cannot participate. If you join the study, you can expect to provide feedback and data about your experience, which will help researchers understand how effective and acceptable these tools are for managing weight during pregnancy. This study is not yet recruiting participants, so keep an eye out for updates if you're interested!

Gender

FEMALE

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 14 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 10 months following screening.