Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial
Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial
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DOI：
10.1016/j.cct.2015.11.018
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发表时间：
2016-01-01
影响因子：
2.2
通讯作者：
McAuliffe, Fionnuala M.
中科院分区：
文献类型：
--
作者：
Kennelly, Maria A.;Ainscough, Kate;McAuliffe, Fionnuala M.
目的：母亲肥胖增加妊娠期GDM的风险。低血糖指数（GI）的饮食干预已被发现，以改善葡萄糖稳态和减少妊娠体重增加。移动的健康（mHealth）技术辅助的干预措施作为治疗许多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与常规护理相比，以mHealth智能手机技术为支持的“健康生活方式套餐”对超重和肥胖孕妇GDM发病率的影响。方法：我们提出了一项随机对照试验，在BMI >= 25 kg/m（2）-39.9 kg/m（2）的孕妇中比较mHealth辅助健康生活方式干预包与标准产科护理。2）。患者以1：1的比例随机分配至对照组或干预组。干预组健康生活方式套餐包括鼓励行为改变的动机咨询会议，包括有针对性的低GI营养建议和妊娠18周前提供的日常体力活动处方，以及智能手机应用程序，以在整个妊娠期间提供持续的健康生活方式建议和支持。主要结果是妊娠29周时GDM的发生率，功效分析表明每组需要253名妇女才能检测出差异。这将是第一个临床试验，以评估智能手机技术辅助的有针对性的健康生活方式干预的有效性，这是基于行为改变理论和技术，支持对超重和肥胖孕妇进行产前管理，以预防GDM。(C)© 2015 Elsevier Inc版权所有。
Objective: 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.Methods: We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI >= 25 kg/m(2)-39.9 kg/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 18 weeks 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 29 weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference.Conclusion: 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. (C) 2015 Elsevier Inc All rights reserved.