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dc.contributor.authorJelsma, Judith GM
dc.contributor.authorvan Poppel, Mireille NM
dc.contributor.authorGaljaard, Sander
dc.contributor.authorDesoye, Gernot
dc.contributor.authorCorcoy, Rosa
dc.contributor.authorDevlieger, Roland
dc.contributor.authorvan Assche, Andre
dc.contributor.authorTimmerman, Dirk
dc.contributor.authorJans, Goele
dc.contributor.authorHarreiter, Jurgen
dc.contributor.authorKautzky-Willer, Alexandra
dc.contributor.authorDamm, Peter
dc.contributor.authorMathiesen, Elisabeth R
dc.contributor.authorJensen, Dorte M
dc.contributor.authorAndersen, Liselotte
dc.contributor.authorDunne, Fidelma
dc.contributor.authorLapolla, Annunziata
dc.contributor.authorDi Cianni, Graziano
dc.contributor.authorBertolotto, Alessandra
dc.contributor.authorWender-Oegowska, Ewa
dc.contributor.authorZawiejska, Agnieszka
dc.contributor.authorBlumska, Kinga
dc.contributor.authorHill, David
dc.contributor.authorRebollo, Pablo
dc.contributor.authorSnoek, Frank J
dc.contributor.authorSimmons, David
dc.date.accessioned2013-07-15T11:49:26Z
dc.date.available2013-07-15T11:49:26Z
dc.date.issued2013-07-05
dc.identifier.citationBMC Pregnancy and Childbirth. 2013 Jul 05;13(1):142
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2393-13-142
dc.identifier.urihttp://hdl.handle.net/10147/296002
dc.description.abstractAbstract Background Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Methods/design 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. Discussion 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. Trial registration ISRCTN70595832
dc.titleDALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial ¿ study protocol
dc.typeJournal Article
dc.language.rfc3066en
dc.rights.holderJudith GM Jelsma et al.; licensee BioMed Central Ltd.
dc.description.statusPeer Reviewed
dc.date.updated2013-07-12T11:49:15Z
refterms.dateFOA2018-08-23T06:13:58Z
html.description.abstractAbstract Background Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. Methods/design Pregnant women at risk of GDM (BMI&#8805;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&lt;5.1mmol; 1 hour glucose &lt;10.0 mmol; 2 hour glucose &lt;8.5 mmol) and randomized to one of the 8 intervention arms using a 2&#215;(2&#215;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 &lt;5kg and either 7 healthy eating &#8216;messages&#8217; and/or 5 physical activity &#8216;messages&#8217; 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&#8211;28 weeks, 35&#8211;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. Discussion 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. Trial registration ISRCTN70595832


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