title: DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol.
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
  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<5.1 mmol; 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 <5 kg 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN70595832.
authors.affiliation: 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. mnm.vanpoppel@vumc.nl.
authors.forename: Judith G M
authors.initials: JG
authors.lastname: Jelsma
authors.forename: Mireille N M
authors.initials: MN
authors.lastname: van Poppel
authors.forename: Sander
authors.initials: S
authors.lastname: Galjaard
authors.forename: Gernot
authors.initials: G
authors.lastname: Desoye
authors.forename: Rosa
authors.initials: R
authors.lastname: Corcoy
authors.forename: Roland
authors.initials: R
authors.lastname: Devlieger
authors.forename: Andre
authors.initials: A
authors.lastname: van Assche
authors.forename: Dirk
authors.initials: D
authors.lastname: Timmerman
authors.forename: Goele
authors.initials: G
authors.lastname: Jans
authors.forename: Jurgen
authors.initials: J
authors.lastname: Harreiter
authors.forename: Alexandra
authors.initials: A
authors.lastname: Kautzky-Willer
authors.forename: Peter
authors.initials: P
authors.lastname: Damm
authors.forename: Elisabeth R
authors.initials: ER
authors.lastname: Mathiesen
authors.forename: Dorte M
authors.initials: DM
authors.lastname: Jensen
authors.forename: Liselotte
authors.initials: L
authors.lastname: Andersen
authors.forename: Fidelma
authors.initials: F
authors.lastname: Dunne
authors.forename: Annunziata
authors.initials: A
authors.lastname: Lapolla
authors.forename: Graziano
authors.initials: G
authors.lastname: Di Cianni
authors.forename: Alessandra
authors.initials: A
authors.lastname: Bertolotto
authors.forename: Ewa
authors.initials: E
authors.lastname: Wender-Oegowska
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Zawiejska
authors.forename: Kinga
authors.initials: K
authors.lastname: Blumska
authors.forename: David
authors.initials: D
authors.lastname: Hill
authors.forename: Pablo
authors.initials: P
authors.lastname: Rebollo
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Snoek
authors.forename: David
authors.initials: D
authors.lastname: Simmons
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose; D016640:Diabetes, Gestational / Q000097:blood / Q000517:prevention & control*; D004032:Diet; D019587:Dietary Supplements; D005060:Europe; D005260:Female; D006801:Humans; D007333:Insulin Resistance; D008019:Life Style; D062405:Motivational Interviewing; D009043:Motor Activity; D010353:Patient Education as Topic; D011247:Pregnancy; D012107:Research Design; D014807:Vitamin D / Q000008:administration & dosage*; D014815:Vitamins / Q000008:administration & dosage*; D015430:Weight Gain; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D014815:Vitamins; D014807:Vitamin D