A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study
- PMID: 33184151
- PMCID: PMC7818327
- DOI: 10.2337/dc20-1216
A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study
Abstract
Objective: SMART-GDM examined whether Habits-GDM, a smartphone application (app) coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control and maternal and neonatal outcomes in gestational diabetes mellitus (GDM).
Research design and methods: In this randomized controlled trial, women diagnosed with GDM between 12 and 30 weeks were randomly assigned to usual care (control) or to 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.
Results: In total, 340 women were randomized (170 intervention, 170 control; mean ± SD age 32.0 ± 4.2 years; mean BMI 25.6 ± 5.6 kg/m2). 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 the intervention group (mean difference -0.15 mmol/L [95% CI -0.26; -0.03], P = 0.011) as were the proportions of glucose above targets (premeal: 17.9% vs. 23.3%, odds ratio 0.68 [95% CI 0.53; 0.87], P = 0.003; 2-h postmeal: 19.9% vs. 50%, 0.54 [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, and perinatal death) were significantly lower in the intervention group (38.1% vs. 53.7%, 0.53 [0.34; 0.84], P = 0.006).
Conclusions: When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (nonprespecified) but did not reduce EGWG among women with GDM.
Trial registration: ClinicalTrials.gov NCT03249896.
© 2020 by the American Diabetes Association.
Comment in
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Apps and the Woman With Gestational Diabetes Mellitus.Diabetes Care. 2021 Feb;44(2):313-315. doi: 10.2337/dci20-0068. Diabetes Care. 2021. PMID: 33472965 No abstract available.
References
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- Yew TW, Khoo CM, Thai AC, Kale AS, Yong EL, Tai ES. The prevalence of gestational diabetes mellitus among Asian females is lower using the new 2013 World Health Organization diagnostic criteria. Endocr Pract 2014;20:1064–1069 - PubMed
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- Perkins JM, Dunn JP, Jagasia SM. Perspectives in gestational diabetes mellitus: a review of screening, diagnosis, and treatment. Clin Diabetes 2007;25:57–62
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