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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.identifier.citationJelsma, Judith GM; van Poppel, Mireille NM; Galjaard, Sander; Desoye, Gernot; Corcoy, Rosa; Devlieger, Roland; van Assche, Andre; Timmerman, Dirk; Jans, Goele; Harreiter, Jurgen; Kautzky-Willer, Alexandra; Damm, Peter; Mathiesen, Elisabeth R; Jensen, Dorte M; Andersen, Liselotte; Dunne, Fidelma; Lapolla, Annunziata; Di Cianni, Graziano; Bertolotto, Alessandra; Wender-Oegowska, Ewa; Zawiejska, Agnieszka; Blumska, Kinga; Hill, David; Rebollo, Pablo; Snoek, Frank J; Simmons, David (2013). Dali: vitamin d and lifestyle intervention for gestational diabetes mellitus (gdm) prevention: an european multicentre, randomised trial – study protocol. BMC Pregnancy and Childbirth 13 ,
dc.description.abstractBackground: 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/m(2))) 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 2x(2x2) 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.
dc.publisherSpringer Nature
dc.relation.ispartofBMC Pregnancy and Childbirth
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 Ireland
dc.subjectgestational diabetes mellitus
dc.subjectlifestyle intervention
dc.subjectrandomised controlled trial
dc.subjecthealthy eating
dc.subjectphysical activity
dc.subjectmotivational interviewing
dc.subjectvitamin d
dc.subjectneonatal body-composition
dc.subjectobese pregnant-women
dc.subjectfetal liver length
dc.subjectlean mass
dc.subjectskinfold measurements
dc.subjectvenous doppler
dc.titleDali: vitamin d and lifestyle intervention for gestational diabetes mellitus (gdm) prevention: an european multicentre, randomised trial – study protocol

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