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    DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial ¿ study protocol

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    Authors
    Jelsma, 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
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    Issue Date
    2013-07-05
    
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    Citation
    BMC Pregnancy and Childbirth. 2013 Jul 05;13(1):142
    URI
    http://dx.doi.org/10.1186/1471-2393-13-142
    http://hdl.handle.net/10147/296002
    Abstract
    Abstract 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
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