DALI

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 an...

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Detalles Bibliográficos
Autores: Jelsma, Judith G. M.|||0000-0001-7943-9160, van Poppel, Mirelle N.M., Galjaard, Sander|||0000-0002-4254-6664, Desoye, Gernot|||0000-0002-5715-3230, Corcoy i Pla, Rosa|||0000-0001-5055-6814, Devlieger, Roland|||0000-0001-7837-4684, van Assche, Andre, Timmerman, Dirk|||0000-0002-3707-6645, Jans, Goele, Harreiter, Jurgen, Kautzky-Willer, Alexandra|||0000-0002-3520-4105, Damm, Peter|||0000-0002-2067-5246, Mathiesen, Elisabeth Reinhardt|||0000-0003-3279-0863, Jensen, Dorte M.|||0000-0002-3298-9824, Andersen, Lise-Lotte|||0000-0003-2997-2228, Dunne, Fidelma|||0000-0003-3682-9403, Lapolla, Annunziata, Di Cianni, Graziano, Bertolotto, Alessandra|||0000-0003-1578-5421, Wender-Oegowska, Ewa, Zawiejska, Agnieszka|||0000-0002-3616-6550, Blumska, Kinga, Hill, David, Rebollo Álvarez, Pablo, Snoek, Frank J., Simmons, David|||0000-0003-0560-0761
Tipo de recurso: artículo
Fecha de publicación:2013
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:303286
Acceso en línea:https://ddd.uab.cat/record/303286
https://dx.doi.org/urn:doi:10.1186/1471-2393-13-142
Access Level:acceso abierto
Palabra clave:Gestational diabetes mellitus
Healthy eating
Lifestyle intervention
Motivational interviewing
Overweight
Physical activity
Pregnancy
Prevention
Randomised controlled trial
Vitamin D
Descripción
Sumario: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.