Dali: vitamin d and lifestyle intervention for gestational diabetes mellitus (gdm) prevention: an european multicentre, randomised trial – study protocol
Jelsma, Judith GM van Poppel, Mireille NM Galjaard, Sander Desoye, Gernot Corcoy, Rosa Devlieger, Roland van Assche, Andre Timmerman, Dirk Jans, Goele Harreiter, Jurgen
Jelsma, Judith GM
van Poppel, Mireille NM
Galjaard, Sander
Desoye, Gernot
Corcoy, Rosa
Devlieger, Roland
van Assche, Andre
Timmerman, Dirk
Jans, Goele
Harreiter, Jurgen
Publication Date
2013-07-05
Keywords
gestational diabetes mellitus, pregnancy, lifestyle intervention, randomised controlled trial, healthy eating, physical activity, overweight, motivational interviewing, prevention, vitamin d, neonatal body-composition, obese pregnant-women, fetal liver length, physical-activity, insulin-resistance, weight-gain, lean mass, skinfold measurements, venous doppler, growth
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Article
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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 ,
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.
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Springer Nature
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Attribution-NonCommercial-NoDerivs 3.0 Ireland