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

Sponsor: Arkansas Children's Hospital Research Institute • ClinicalTrials.gov ID: NCT06666257

Registry updated: 2026-10-09

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Description

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.

Interventions

Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy (Behavioral)
The intervention we are basing our adaptations on is a ecological momentary intervention, meaning it is integrated into participants daily lifestyle and schedule. Using an established framework for tracking daily body weight and physical activity, a gestational weight gain trajectory is estimated. Based on the data, recommendation prompts for exercise and diet will be discussed with participants during motivational interviewing. For the CGM piece, participants will wear unblinded CGM devices and have access to CGM linked app features that allow insights and reactivity to personal glycemic data

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.

Conditions

Pregnancies at Increased Risk for Excessive Gestational Weight Gain Ecological Momentary Assessment and Intervention Continuous Glucose Monitor

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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