School of Agriculture and Food Science, University College Dublin, Belfield, Dublin, Ireland.
UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.
Trials. 2021 Dec 28;22(1):963. doi: 10.1186/s13063-021-05892-4.
Gestational diabetes (GDM) impacts 8-18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM.
Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks' gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received.
Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation.
Australian New Zealand Clinical Trials Registry ACTRN12620001240932 . Registered on 19 November 2020.
妊娠糖尿病（GDM）影响 8-18%的妊娠，大大增加了母亲和儿童患 2 型糖尿病和肥胖等非传染性疾病的风险。虽然孕期和产后的生活方式干预可以降低这种风险，但在提供具有足够人群渗透力和参与度的可实施干预措施方面，仍存在研究转化方面的差距。“糖尿病撞击婴儿（Impact Diabetes Bump2Baby）”项目是一个循证护理系统的实施项目，旨在预防超重和肥胖。Bump2Baby and Me 是一项多中心随机对照试验，旨在研究孕期和产后使用移动健康（mHealth）教练方案对有发展为 GDM 高风险的妇女的有效性。
将从爱尔兰、英国、西班牙和澳大利亚的 4 个临床站点在孕早期招募 800 名妇女。将使用经过验证的 Monash GDM 筛查工具对妇女进行资格筛查。参与者将在 12-24 周妊娠时入组，并按照 1:1 的比例随机分配到干预组或对照组。除了常规护理外，干预措施还包括通过智能手机应用程序进行 mHealth 教练，该应用程序使用同步和异步视频及短信相结合的方式，并允许与经过培训的健康教练进行个性化支持和目标设定。对照组接受常规护理。所有妇女及其儿童将从孕早期一直随访至产后 12 个月。主要结局是产后 12 个月时产妇体重指数（BMI）的差异为 0.8kg/m。次要的产妇和婴儿结局包括 GDM 的发展、妊娠体重增加、妊娠结局、饮食、身体活动、睡眠以及新生儿体重和婴儿生长模式的改善。这个为期 5 年的项目由欧盟委员会的 Horizon 2020 和澳大利亚国家卫生和医学研究委员会资助。已获得伦理批准。
以前的干预措施并未从严格控制的疗效试验转移到常规服务提供中。本项目旨在提供循证、可持续的支持，以便在孕期和产后纳入妇女的常规护理。这项研究将提供证据，以告知母亲和下一代早期预防肥胖和糖尿病等非传染性疾病。
澳大利亚和新西兰临床试验注册 ACTRN12620001240932 。于 2020 年 11 月 19 日注册。
