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.
Currently pregnant or pregnant within the past 36 months.
Community partners with relevant perspectives to inform recruitment, adaptation approaches and feasibility of the phase 2 pilot trial.
pregnant women less than 20 weeks of gestation at time of screening
18-45 years of age
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)
Single group
Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancy
BehavioralThe 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
Feasibility data of the modified EMI: AR-GEM Study - Recruitment and Retention
Maternal recruitment and retention rates (total number of participants recruited and retained)
Feasibility data of the modified EMI: SmartMomsAR - Acceptability
Acceptability scores from online intervention satisfaction questionnaires, 5 point Likert Scale system
Feasibility data of the modified EMI: SmartMomsAR - Protocol Adherence
Adherence to study protocol via process measures. (Percentage of complete data points)
Incidence of appropriate gestational weight gain per 2009 NASM guidelines.
Frequencies (percentage) of appropriate gestational weight gain incidence. Maternal weight (lbs) over time.
Change in healthful lifestyle behaviors - HEI
Change scores for healthy eating index (HEI)
Change in healthful lifestyle behaviors - Steps (Physical Activity)
Change scores for physical activity counts (steps) as assessed commercial accelerometer.
Change in healthful lifestyle behaviors - Glycemic profile
Summary of glycemic profile data (mg/dL) as assessed by CGM.
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Arkansas Children's Hospital Research Institute
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator
