Sukumar Nithya, Dallosso Helen, Saravanan Ponnusamy, Yates Tom, Telling Carol, Shorthose Karen, Northern Alison, Schreder Sally, Brough Christopher, Gray Laura J, Davies Melanie J, Khunti Kamlesh
Population, Evidence & Technologies, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Academic Centre for Diabetes and Endocrinology, George Eliot Hospital, Nuneaton, CV10 7DJ, UK.
Trials. 2018 Dec 12;19(1):682. doi: 10.1186/s13063-018-3067-8.
BACKGROUND: A diagnosis of gestational diabetes (GDM) is associated with an over sevenfold increase in the risk of developing type 2 diabetes (T2D), while among parous women with T2D, up to 30% have a history of GDM. Lifestyle interventions have been shown to reduce the risk of incident T2D in adults with impaired glucose tolerance, including in women with a history of GDM. The aim of this study is to establish whether a group self-management education programme, supported by a mobile web application, can improve levels of physical activity at 12 months in women who have had GDM. METHODS: The study is a randomised controlled trial with follow-up at 6 and 12 months. Primary outcome is change in objectively measured average daily physical activity at 12 months. Secondary outcomes include lipid profile, blood pressure, glycated haemoglobin, obesity, smoking and alcohol status, self-reported physical activity, anxiety, depression and quality of life. Participants are recruited from maternity and diabetes departments in hospital trusts in two sites in the UK. Women aged > 18 years, with a diagnosis of GDM during any pregnancy in the previous 60 months are eligible. Participants need to have a good understanding of written and verbal English, be able to give informed consent and have access to a smart-phone. Women who are pregnant or have type 1 or type 2 diabetes are not eligible. In total, 290 participants will be recruited and randomly assigned, with stratification for age and ethnicity, to either the control group, receiving usual care, or the intervention group who are invited to participate in the Baby Steps programme. This comprises a group education programme and access to a mobile web application which provides an education component and interacts with a wrist-worn activity monitor providing automated messages, setting challenges and encouraging motivation. DISCUSSION: If effective, the Baby Steps programme could be translated into a primary care-based intervention that women with GDM are referred to in the postnatal period. This could help them make lifestyle changes that could reduce their future risk of T2D. TRIAL REGISTRATION: ISRCTN, ISRCTN17299860 . Registered on 5 April 2017.
背景：妊娠期糖尿病（GDM）的诊断与患2型糖尿病（T2D）风险增加逾7倍相关，而在患有T2D的经产妇中，高达30%有GDM病史。生活方式干预已被证明可降低糖耐量受损成年人发生T2D的风险，包括有GDM病史的女性。本研究的目的是确定在移动网络应用程序支持下的小组自我管理教育计划能否在12个月时提高有GDM病史女性的身体活动水平。 方法：该研究为一项随机对照试验，随访6个月和12个月。主要结局是12个月时客观测量的平均每日身体活动变化。次要结局包括血脂谱、血压、糖化血红蛋白、肥胖、吸烟和饮酒状况、自我报告的身体活动、焦虑、抑郁和生活质量。参与者从英国两个地点的医院信托机构的产科和糖尿病科招募。年龄大于18岁、在过去60个月内任何一次妊娠期间被诊断为GDM的女性符合条件。参与者需要具备良好的书面和口头英语理解能力，能够给予知情同意并能使用智能手机。怀孕或患有1型或2型糖尿病的女性不符合条件。总共将招募290名参与者，并根据年龄和种族分层，随机分配到接受常规护理的对照组或被邀请参加“小步计划”的干预组。该计划包括小组教育计划和使用移动网络应用程序，该应用程序提供教育内容，并与佩戴在手腕上的活动监测器互动，提供自动信息、设定挑战并鼓励积极性。 讨论：如果有效，“小步计划”可转化为基于初级保健的干预措施，供产后有GDM的女性使用。这有助于她们做出生活方式改变，降低未来患T2D的风险。 试验注册：ISRCTN，ISRCTN17299860。于2017年4月5日注册。
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