A Randomized Controlled Trial to Evaluate the Effects of a Smartphone App-based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, Maternal and Neonatal Outcomes in Women with Gestational Diabetes: The SMART-GDM Study
SMART-GDM examined whether Habits-GDM, a smartphone app coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control, maternal and neonatal outcomes in gestational diabetes mellitus (GDM).
RESEARCH DESIGN AND METHODS
In this randomized controlled trial, women diagnosed with GDM between 12-30 weeks were randomly assigned usual care (Control) or additional support from Habits-GDM that integrated dietary, physical activity, weight and glucose monitoring (Intervention). The primary outcome was the proportion of participants with EGWG. Secondary outcomes included absolute gestational weight gain (GWG), glycemic control, and maternal, delivery and neonatal outcomes.
In total, 340 women were randomized (170 Intervention, 170 Control; mean age 32.0 years [SD 4.2]; mean BMI 25.6kg/m2 [SD 5.6]). There were no statistically significant differences in the proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes between experimental groups. Average glucose readings were lower in Intervention (mean difference -0.15mmol/L [95% CI -0.26; -0.03]; P=0.011), so were the proportions of glucose above targets (pre-meal 17.9% vs. 23.3%, OR=0.68 [95% CI 0.53; 0.87]; P=0.003; 2-hours post-meal 19.9% vs. 50%, OR=0.54 [95% CI 0.42; 0.70]; P<0.001). When regarded as a composite (although not prespecified), the overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, perinatal death) were significantly lower in Intervention (38.1% vs. 53.7%, OR=0.53 [95% CI 0.34; 0.84]; P=0.006).
When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (non-prespecified), but did not reduce EGWG among women with GDM.