Not Yet RecruitingNot Applicable

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

16 participantsStarted 2025-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention

Timeframe: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

Feasibility data of the modified EMI: SmartMomsAR - Acceptability

Timeframe: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence

Timeframe: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

Trial details

NCT IDNCT06666257

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

Lisa T Jansen, PhD

5013646516 ltjansen@uams.edu

View on ClinicalTrials.gov More Pregnancies at Increased Risk for Excessive Gestational Weight Gain trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention

Timeframe: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

Feasibility data of the modified EMI: SmartMomsAR - Acceptability

Timeframe: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months

Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence

Timeframe: continuous, from study enrollment at 16-20 weeks until study completion, an average of 6 months