DALI : Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: An European multicentre, randomised trial - study protocol
Jelsma, Judith G. M (VU University Medical Centre (Amsterdam, Països Baixos))
van Poppel, Mirelle N.M. (VU University Medical Centre (Amsterdam, Països Baixos))
Galjaard, Sander (University Hospitals Leuven (Bèlgica))
Desoye, Gernot (Medizinische Universitaet Graz (Graz, Àustria))
Corcoy i Pla, Rosa (Institut d'Investigació Biomèdica Sant Pau)
Devlieger, Roland (University Hospitals Leuven (Bèlgica))
van Assche, Andre (University Hospitals Leuven (Bèlgica))
Timmerman, Dirk (University Hospitals Leuven (Bèlgica))
Jans, Goele (University Hospitals Leuven (Bèlgica))
Harreiter, Jurgen (Medical University of Vienna)
Kautzky-Willer, Alexandra (Medical University of Vienna)
Damm, Peter (University of Copenhagen)
Mathiesen, Elisabeth Reinhardt (University of Copenhagen)
Jensen, Dorte M. (Odense University Hospital (Dinamarca))
Andersen, Lise-Lotte (Odense University Hospital (Dinamarca))
Dunne, Fidelma (National University of Ireland)
Lapolla, Annunziata (Universita Degli Studi di Padova)
Di Cianni, Graziano (Università di Pisa)
Bertolotto, Alessandra (Università di Pisa)
Wender-Oegowska, Ewa (Uniwersytet Medyczny im Karola Marcinkowskiego W Poznaniu)
Zawiejska, Agnieszka (Uniwersytet Medyczny im Karola Marcinkowskiego W Poznaniu)
Blumska, Kinga (Uniwersytet Medyczny im Karola Marcinkowskiego W Poznaniu)
Hill, David (6 Recherche en Santé Lawson SA (Suïssa))
Rebollo Álvarez, Pablo (BAP Health Outcomes Research SL (Oviedo, Espanya))
Snoek, Frank J. (VU University Medical Centre (Amsterdam, Països Baixos))
Simmons, David (Addenbrookes Hospital (Cambridge, Regne Unit))
Universitat Autònoma de Barcelona. Departament de Medicina

Data:	2013
Resum:	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/m)) 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. © 2013 Jelsma et al. ; licensee BioMed Central Ltd.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Gestational diabetes mellitus ; Healthy eating ; Lifestyle intervention ; Motivational interviewing ; Overweight ; Physical activity ; Pregnancy ; Prevention ; Randomised controlled trial ; Vitamin D
Publicat a:	BMC pregnancy and childbirth, Vol. 13 (may 2013) , p. 142, ISSN 1471-2393

DOI: 10.1186/1471-2393-13-142
PMID: 23829946

16 p, 477.2 KB

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