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

Hdl Handle:
http://hdl.handle.net/10147/296002
Title:
DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial ¿ study protocol
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
Citation:
BMC Pregnancy and Childbirth. 2013 Jul 05;13(1):142
Issue Date:
5-Jul-2013
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
Item Type:
Journal Article

Full metadata record

DC FieldValue Language
dc.contributor.authorJelsma, Judith GM-
dc.contributor.authorvan Poppel, Mireille NM-
dc.contributor.authorGaljaard, Sander-
dc.contributor.authorDesoye, Gernot-
dc.contributor.authorCorcoy, Rosa-
dc.contributor.authorDevlieger, Roland-
dc.contributor.authorvan Assche, Andre-
dc.contributor.authorTimmerman, Dirk-
dc.contributor.authorJans, Goele-
dc.contributor.authorHarreiter, Jurgen-
dc.contributor.authorKautzky-Willer, Alexandra-
dc.contributor.authorDamm, Peter-
dc.contributor.authorMathiesen, Elisabeth R-
dc.contributor.authorJensen, Dorte M-
dc.contributor.authorAndersen, Liselotte-
dc.contributor.authorDunne, Fidelma-
dc.contributor.authorLapolla, Annunziata-
dc.contributor.authorDi Cianni, Graziano-
dc.contributor.authorBertolotto, Alessandra-
dc.contributor.authorWender-Oegowska, Ewa-
dc.contributor.authorZawiejska, Agnieszka-
dc.contributor.authorBlumska, Kinga-
dc.contributor.authorHill, David-
dc.contributor.authorRebollo, Pablo-
dc.contributor.authorSnoek, Frank J-
dc.contributor.authorSimmons, David-
dc.date.accessioned2013-07-15T11:49:26Z-
dc.date.available2013-07-15T11:49:26Z-
dc.date.issued2013-07-05-
dc.identifier.citationBMC Pregnancy and Childbirth. 2013 Jul 05;13(1):142-
dc.identifier.urihttp://dx.doi.org/10.1186/1471-2393-13-142-
dc.identifier.urihttp://hdl.handle.net/10147/296002-
dc.description.abstractAbstract 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-
dc.titleDALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial ¿ study protocol-
dc.typeJournal Article-
dc.language.rfc3066en-
dc.rights.holderJudith GM Jelsma et al.; licensee BioMed Central Ltd.-
dc.description.statusPeer Reviewed-
dc.date.updated2013-07-12T11:49:15Z-
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