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

BMC Pregnancy and Childbirth

David Simmons⁴  Frank J Snoek⁹  Pablo Rebollo^1,12  David Hill²  Kinga Blumska^1,11  Agnieszka Zawiejska^1,11  Ewa Wender-Oegowska^1,11  Alessandra Bertolotto^1,15  Graziano Di Cianni^1,15  Annunziata Lapolla^1,10  Fidelma Dunne¹  Liselotte Andersen⁵  Dorte M Jensen⁵  Elisabeth R Mathiesen^1,13  Peter Damm^1,13  Alexandra Kautzky-Willer³  Jurgen Harreiter³  Goele Jans⁷  Dirk Timmerman⁷  Andre van Assche⁷  Roland Devlieger⁷  Rosa Corcoy⁶  Gernot Desoye^1,14  Sander Galjaard⁷  Mireille NM van Poppel⁸  Judith GM Jelsma⁸ 

[1] National University of Ireland, Galway, Ireland;6 Recherche en Santé Lawson SA, Bronschhofen, Switzerland;Medical University of Vienna, Vienna City, Austria;Institute of Metabolic Science, Addenbrookes Hospital, Cambridge, England;Odense University Hospital, Odense, Denmark;CIBER Bioengineering, Biomaterials and Nanotechnology, Instituto de Salud Carlos III, Madrid, Spain;KU Leuven Department of Development and Regeneration: Pregnancy, Fetus and Neonate, Gynaecology and Obstetrics, University Hospitals Leuven, Leuven, Belgium;Department of Public and Occupational Health, EMGO+−Institute for Health and Care Research, VU University Medical Centre, Van der Boechorststraat 7, 1081BT Amsterdam, the Netherlands;Department of Medical Psychology, EMGO+−Institute for Health and Care Research, VU University Medical Centre, Amsterdam, the Netherlands;Universita Degli Studi di Padova, Padua, Italy;Uniwersytet Medyczny im Karola Marcinkowskiego W Poznaniu, Poznan, Poland;BAP Health Outcomes Research SL, Oviedo, Spain;Center for Pregnant Women with Diabetes, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark;Department of Obstetrics and Gynecology, Medizinische Universitaet Graz, Graz, Austria;Università di Pisa, Pisa, Italy

关键词: Vitamin D;    Prevention;    Motivational interviewing;    Overweight;    Physical activity;    Healthy eating;    Randomised controlled trial;    Lifestyle intervention;    Pregnancy;    Gestational diabetes mellitus;   

Others  :  1137968
DOI  :  10.1186/1471-2393-13-142

 received in 2013-05-23, accepted in 2013-07-01,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Jelsma et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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