Dali: vitamin d and lifestyle intervention for gestational diabetes mellitus (gdm) prevention: an european multicentre, randomised trial – study protocol
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2013-07-05Author
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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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 (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 ,
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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/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.