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

Tong Wei Yew, Claudia Chi, Shiao-Yng Chan, Rob M van Dam, Clare Whitton, Chang Siang Lim, Pin Sym Foong, Winni Fransisca, Chieu Leng Teoh, Jeannie Chen, Su Tin Ho-Lim, Su Lin Lim, Kai Wen Ong, Peck-Hoon Ong, Bee Choo Tai, E Shyong Tai, Tong Wei Yew, Claudia Chi, Shiao-Yng Chan, Rob M van Dam, Clare Whitton, Chang Siang Lim, Pin Sym Foong, Winni Fransisca, Chieu Leng Teoh, Jeannie Chen, Su Tin Ho-Lim, Su Lin Lim, Kai Wen Ong, Peck-Hoon Ong, Bee Choo Tai, E Shyong Tai

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.

References

    1. Chong YS, Cai S, Lin H, et al. .; GUSTO study group . Ethnic differences translate to inadequacy of high-risk screening for gestational diabetes mellitus in an Asian population: a cohort study. BMC Pregnancy Childbirth 2014;14:345.
    1. 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
    1. Perkins JM, Dunn JP, Jagasia SM. Perspectives in gestational diabetes mellitus: a review of screening, diagnosis, and treatment. Clin Diabetes 2007;25:57–62
    1. Horvath K, Koch K, Jeitler K, et al. . Effects of treatment in women with gestational diabetes mellitus: systematic review and meta-analysis. BMJ 2010;340:c1395.
    1. Kominiarek MA, Saade G, Mele L, et al. .; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network . Association between gestational weight gain and perinatal outcomes. Obstet Gynecol 2018;132:875–881
    1. Kim SY, Sharma AJ, Sappenfield W, Wilson HG, Salihu HM. Association of maternal body mass index, excessive weight gain, and gestational diabetes mellitus with large-for-gestational-age births. Obstet Gynecol 2014;123:737–744
    1. Margerison Zilko CE, Rehkopf D, Abrams B. Association of maternal gestational weight gain with short- and long-term maternal and child health outcomes. Am J Obstet Gynecol 2010;202:574.e1–574.e8
    1. Al Mamun A, Mannan M, O’Callaghan MJ, Williams GM, Najman JM, Callaway LK. Association between gestational weight gain and postpartum diabetes: evidence from a community based large cohort study. PLoS One 2013;8:e75679.
    1. Bogaerts AFL, Devlieger R, Nuyts E, Witters I, Gyselaers W, Van den Bergh BRH. Effects of lifestyle intervention in obese pregnant women on gestational weight gain and mental health: a randomized controlled trial. Int J Obes 2013;37:814–821
    1. Hui AL, Back L, Ludwig S, et al. . Effects of lifestyle intervention on dietary intake, physical activity level, and gestational weight gain in pregnant women with different pre-pregnancy Body Mass Index in a randomized control trial. BMC Pregnancy Childbirth 2014;14:331.
    1. Ronnberg AK, Ostlund I, Fadl H, Gottvall T, Nilsson K. Intervention during pregnancy to reduce excessive gestational weight gain—a randomised controlled trial. BJOG 2015;122:537–544
    1. Garabedian LF, Ross-Degnan D, Wharam JF. Mobile phone and smartphone technologies for diabetes care and self-management. Curr Diab Rep 2015;15:109.
    1. Wu X, Guo X, Zhang Z. The efficacy of mobile phone apps for lifestyle modification in diabetes: systematic review and meta-analysis. JMIR Mhealth Uhealth 2019;7:e12297.
    1. Tufano JT, Karras BT. Mobile eHealth interventions for obesity: a timely opportunity to leverage convergence trends. J Med Internet Res 2005;7:e58.
    1. Wigginton C, Curran M, Brodeur C, Curran M, Brodeur C. Global Mobile Consumer Trends. 2nd ed. New York, Deloitte Touche Tohmatsu Ltd., 2017
    1. Miremberg H, Ben-Ari T, Betzer T, et al. . The impact of a daily smartphone-based feedback system among women with gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized controlled trial. Am J Obstet Gynecol 2018;218:453.e1–453.e7
    1. Hirst JE, Mackillop L, Loerup L, et al. . Acceptability and user satisfaction of a smartphone-based, interactive blood glucose management system in women with gestational diabetes mellitus. J Diabetes Sci Technol 2015;9:111–115
    1. Skar JB, Garnweidner-Holme LM, Lukasse M, Terragni L. Women’s experiences with using a smartphone app (the Pregnant+ app) to manage gestational diabetes mellitus in a randomised controlled trial. Midwifery 2018;58:102–108
    1. Garnweidner-Holme LM, Borgen I, Garitano I, Noll J, Lukasse M. Designing and developing a mobile smartphone application for women with gestational diabetes mellitus followed-up at diabetes outpatient clinics in Norway. Healthcare (Basel) 2015;3:310–323
    1. Lau Y, Klainin-Yobas P, Htun TP, et al. . Electronic-based lifestyle interventions in overweight or obese perinatal women: a systematic review and meta-analysis. Obes Rev 2017;18:1071–1087
    1. Ming W-K, Mackillop LH, Farmer AJ, et al. . Telemedicine technologies for diabetes in pregnancy: a systematic review and meta-analysis. J Med Internet Res 2016;18:e290.
    1. Guo H, Zhang Y, Li P, Zhou P, Chen L-M, Li S-Y. Evaluating the effects of mobile health intervention on weight management, glycemic control and pregnancy outcomes in patients with gestational diabetes mellitus. J Endocrinol Invest 2019;42:709–714
    1. Mackillop L, Hirst JE, Bartlett KJ, et al. . Comparing the efficacy of a mobile phone-based blood glucose management system with standard clinic care in women with gestational diabetes: randomized controlled trial. JMIR Mhealth Uhealth 2018;6:e71.
    1. Al-Ofi EA, Mosli HH, Ghamri KA, Ghazali SM. Management of postprandial hyperglycaemia and weight gain in women with gestational diabetes mellitus using a novel telemonitoring system. J Int Med Res 2019;47:754–764
    1. Borgen I, Garnweidner-Holme LM, Jacobsen AF, et al. . Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial. BMJ Open 2017;7:e013117
    1. World Health Organization Diagnostic criteria and classification of hyperglycaemia first detected in pregnancy. Geneva, Switzerland, World Health Organization, 2013. Accessed 27 April 2020. Available from
    1. Jena S, Ranjani H, Anjana RM, Mohan V Reality-TV based diabetes prevention for millions of people in India. Abstract presented at the 41st Annual Conference of the Research Society for the Study of Diabetes, New Delhi, India, 8–10 November 2013
    1. Carpenter CJ A meta-analysis of the effectiveness of health belief model variables in predicting behavior. Health Commun 2010;25:661–669
    1. Pearce EE, Evenson KR, Downs DS, Steckler A. Strategies to promote physical activity during pregnancy: a systematic review of intervention evidence. Am J Lifestyle Med 2013;7:38–50
    1. Carter BL, Day SX, Cinciripini PM. Momentary health interventions: where are we and where are we going? In The Science of Real-Time Data Capture: Self-Reports in Health Research. Stone AA, Ed. Oxford, Oxford University Press, 2007, pp. 289–307
    1. Runyan JD, Steenbergh TA, Bainbridge C, Daugherty DA, Oke L, Fry BN. A smartphone ecological momentary assessment/intervention “app” for collecting real-time data and promoting self-awareness. PLoS One 2013;8:e71325.
    1. Institute of Medicine, National Research Council Weight gain during pregnancy: reexamining the guidelines. Washington, DC, The National Academies Press, 2009. Accessed 27 April 2020. Available from
    1. Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry 1987;150:782–786
    1. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA, Consulting Psychologists Press, 1983
    1. Willcox JC, Wilkinson SA, Lappas M, et al. . A mobile health intervention promoting healthy gestational weight gain for women entering pregnancy at a high body mass index: the txt4two pilot randomised controlled trial. BJOG 2017;124:1718–1728
    1. Olson CM, Groth SW, Graham ML, Reschke JE, Strawderman MS, Fernandez ID. The effectiveness of an online intervention in preventing excessive gestational weight gain: the e-moms roc randomized controlled trial. BMC Pregnancy Childbirth 2018;18:148.
    1. Champion ML, Harper LM. Gestational weight gain: update on outcomes and interventions. Curr Diab Rep 2020;20:11.
    1. Bonomo M, Corica D, Mion E, et al. . Evaluating the therapeutic approach in pregnancies complicated by borderline glucose intolerance: a randomized clinical trial. Diabet Med 2005;22:1536–1541
    1. Garner P, Okun N, Keely E, et al. . A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study. Am J Obstet Gynecol 1997;177:190–195
    1. Shepherd E, Gomersall JC, Tieu J, Han S, Crowther CA, Middleton P. Combined diet and exercise interventions for preventing gestational diabetes mellitus. Cochrane Database Syst Rev 2017;11:CD010443.

Source: PubMed

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