Continuous glucose and e-monitoring to support healthy weight gain during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm pilot study to assess the feasibility and acceptability of a remotely delivered behavioral lifestyle intervention, adapted from the SmartMoms framework, for pregnant women with overweight or obesity. Participants receive weekly virtual coaching, review weight, step count, and CGM data, and get tailored guidance on activity and diet, with educational content and peer support. A mock control arm will be created from existing records for preliminary comparisons, and all enrolled participants receive the intervention. The study focuses on feasibility, acceptability, and early signals of impact to inform a future randomized trial, with activities tailored to patients in Arkansas and aligned with current gestational weight gain guidelines.

Why it matters

Who can join: the full rules

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.

Where it's running

• Arkansas Children's Research Institute - Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting

Study contacts

• Principal investigator: Lisa T Jansen, PhD — Arkansas Children's Hospital Research Institute; University of Arkansas for Medical Sciences
• Study coordinator: Lisa T Jansen, PhD
• Email: ltjansen@uams.edu
• Phone: 5013646516

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.