Kennelly Maria A, Ainscough Kate, Lindsay Karen, Gibney Eileen, Mc Carthy Mary, McAuliffe Fionnuala M
UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland.
UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland.
Contemp Clin Trials. 2016 Jan;46:92-99. doi: 10.1016/j.cct.2015.11.018. Epub 2015 Nov 25.
Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chronic diseases. The aim of this study is to assess the impact of a 'healthy lifestyle package' with mHealth smart phone technology as support compared with usual care on the incidence of GDM in an overweight and obese pregnant population.
We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI ≥25kg/m(2)-39.9kg/m(2). Patients are randomized to control or intervention group in a 1:1 ratio. The intervention arm healthy lifestyle package includes a motivational counseling session to encourage behavior change, involving targeted, low GI nutritional advice and daily physical activity prescription delivered before 18weeks gestation, as well as a smart phone app to provide ongoing healthy lifestyle advice and support throughout pregnancy. The primary outcome is the incidence of GDM at 29weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference.
This will be the first clinical trial to evaluate the effectiveness of a smart phone technology-assisted targeted healthy lifestyle intervention, which is grounded in behavior change theories and techniques, to support antenatal management of an overweight and obese pregnant population in preventing GDM.
孕期母体肥胖会增加患妊娠期糖尿病（GDM）的风险。已发现低血糖指数（GI）饮食干预可改善葡萄糖稳态并减少孕期体重增加。移动健康（mHealth）技术辅助干预作为治疗多种慢性病的辅助手段正变得越来越普遍。本研究的目的是评估以mHealth智能手机技术为支持的“健康生活方式套餐”与常规护理相比，对超重和肥胖孕妇群体中GDM发病率的影响。
我们提议对BMI≥25kg/m² - 39.9kg/m²的孕妇进行一项mHealth辅助健康生活方式干预套餐与标准产科护理的随机对照试验。患者按1:1的比例随机分为对照组或干预组。干预组的健康生活方式套餐包括一次激励咨询会议以鼓励行为改变，涉及在妊娠18周前提供有针对性的低GI营养建议和每日体育活动处方，以及一个智能手机应用程序，在整个孕期提供持续的健康生活方式建议和支持。主要结局是妊娠29周时GDM的发病率，功效分析表明每组需要253名女性才能检测到差异。
这将是第一项评估基于行为改变理论和技术的智能手机技术辅助针对性健康生活方式干预在支持超重和肥胖孕妇群体预防GDM的产前管理方面有效性的临床试验。
