DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol.
DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol.
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DOI：
10.1186/1471-2393-13-142
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发表时间：
2013-07-05
影响因子：
3.1
通讯作者：
Simmons D
中科院分区：
文献类型：
--
作者：
Jelsma JG;van Poppel MN;Galjaard S;Desoye G;Corcoy R;Devlieger R;van Assche A;Timmerman D;Jans G;Harreiter J;Kautzky-Willer A;Damm P;Mathiesen ER;Jensen DM;Andersen L;Dunne F;Lapolla A;Di Cianni G;Bertolotto A;Wender-Oegowska E;Zawiejska A;Blumska K;Hill D;Rebollo P;Snoek FJ;Simmons D
妊娠期糖尿病（GDM）是一个日益严重的世界性问题。生活方式干预和/或补充维生素D可能有助于预防一些女性的GDM。来自9个欧洲国家的有GDM风险（BMI≥29 (kg/m2)）的孕妇将被邀请参加，并在妊娠19+6周之前获得同意。在给予知情同意后，将纳入无GDM的女性（基于IADPSG标准：空腹血糖<5.1mmol； 1小时血糖<10.0 mmol； 2小时血糖<8.5 mmol），并使用2x （2×2）因子设计随机分为8个干预组之一：（1)健康饮食（HE）， 2）身体活动（PA）， 3) HE+PA, 4)对照，5)HE+PA+维生素D， 6) HE+PA+安慰剂，7)单独维生素D， 8)单独安慰剂)，每个部位进行预分层。总共将包括880名妇女，每支队伍分配110名妇女。在进入妊娠期至35周期间，分配到生活方式干预组的妇女将根据动机访谈原则接受5次面对面和4次电话指导。生活方式干预包括关于GDM风险的讨论，体重增加目标<5kg，以及7个健康饮食“信息”和/或5个身体活动“信息”（取决于随机分组）。保真度由个人数字辅助（PDA）系统监控。随机分配到维生素D干预组的参与者每天摄入1600国际单位的维生素D或安慰剂，直到分娩。在基线测量、妊娠24-28周、35-37周和分娩后收集数据。主要结局指标是妊娠期体重增加、空腹血糖和胰岛素敏感性，以及一系列产科次要结局指标，包括出生体重。DALI是一项独特的欧洲范围的随机对照试验，它将深入了解超重和肥胖妇女中预防GDM发展的措施。ISRCTN70595832
Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Pregnant women at risk of GDM (BMI≥29 (kg/m2)) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose<5.1mmol; 1 hour glucose <10.0 mmol; 2 hour glucose <8.5 mmol) and randomized to one of the 8 intervention arms using a 2×(2×2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5kg and either 7 healthy eating ‘messages’ and/or 5 physical activity ‘messages’ depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24–28 weeks, 35–37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight. DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women. ISRCTN70595832
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影响因子：
7.1
作者：
Anderson, N. G.;Notley, E.;McEwing, R.
通讯作者：
McEwing, R.
影响因子：
7.1
作者：
de Santis, M. S. Nobile;Taricco, E.;Cetin, I.
通讯作者：
Cetin, I.
DOI：
10.1016/s0002-9378(03)00828-7
发表时间：
2003-12-01
影响因子：
9.8
作者：
Catalano, PM;Thomas, A;Amini, SB
通讯作者：
Amini, SB
影响因子：
3.7
作者：
Brown MJ;Sinclair M;Liddle D;Hill AJ;Madden E;Stockdale J
通讯作者：
Stockdale J
DOI：
10.1038/oby.2001.61
发表时间：
2001-08-01
期刊：
OBESITY RESEARCH
影响因子：
--
作者：
Ben-Noun, L;Sohar, E;Laor, A
通讯作者：
Laor, A