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

Judith G M Jelsma; Mireille N M van Poppel; Sander Galjaard; Gernot Desoye; Rosa Corcoy; Roland Devlieger; Andre van Assche; Dirk Timmerman; Goele Jans; Jurgen Harreiter; Alexandra Kautzky-Willer; Peter Damm; Elisabeth R Mathiesen; Dorte Kold Jensen; Liselotte Andersen; Fidelma Dunne; Annunziata Lapolla; Graziano Di Cianni; Alessandra Bertolotto; Ewa Wender-Oegowska; Agnieszka Zawiejska; Kinga Blumska; David Hill; Pablo Rebollo; Frank J Snoek; David Simmons

doi:10.1186/1471-2393-13-142

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

Judith G M Jelsma, Mireille N M van Poppel, Sander Galjaard, Gernot Desoye, Rosa Corcoy, Roland Devlieger, Andre van Assche, Dirk Timmerman, Goele Jans, Jurgen Harreiter, Alexandra Kautzky-Willer, Peter Damm, Elisabeth R Mathiesen, Dorte Kold Jensen, Liselotte Andersen, Fidelma Dunne, Annunziata Lapolla, Graziano Di Cianni, Alessandra Bertolotto, Ewa Wender-OegowskaAgnieszka Zawiejska, Kinga Blumska, David Hill, Pablo Rebollo, Frank J Snoek, David Simmons

Department of Clinical Medicine

69 Citations (Scopus)

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.

Original language	English
Article number	142
Journal	B M C Pregnancy and Childbirth
Volume	13
Number of pages	16
ISSN	1471-2393
DOIs	https://doi.org/10.1186/1471-2393-13-142
Publication status	Published - 5 Jul 2013

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10.1186/1471-2393-13-142

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Jelsma, J. G. M., van Poppel, M. N. M., Galjaard, S., Desoye, G., Corcoy, R., Devlieger, R., van Assche, A., Timmerman, D., Jans, G., Harreiter, J., Kautzky-Willer, A., Damm, P., Mathiesen, E. R., Jensen, D. K., Andersen, L., Dunne, F., Lapolla, A., Di Cianni, G., Bertolotto, A., ... Simmons, D. (2013). DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial – study protocol. B M C Pregnancy and Childbirth, 13, [142]. https://doi.org/10.1186/1471-2393-13-142

DALI : Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial – study protocol. / Jelsma, Judith G M; van Poppel, Mireille N M; Galjaard, Sander et al.

In: B M C Pregnancy and Childbirth, Vol. 13, 142, 05.07.2013.

Research output: Contribution to journal › Journal article › Research › peer-review

Jelsma, JGM, van Poppel, MNM, Galjaard, S, Desoye, G, Corcoy, R, Devlieger, R, van Assche, A, Timmerman, D, Jans, G, Harreiter, J, Kautzky-Willer, A, Damm, P , Mathiesen, ER, Jensen, DK, Andersen, L, Dunne, F, Lapolla, A, Di Cianni, G, Bertolotto, A, Wender-Oegowska, E, Zawiejska, A, Blumska, K, Hill, D, Rebollo, P, Snoek, FJ & Simmons, D 2013, 'DALI: Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial – study protocol', B M C Pregnancy and Childbirth, vol. 13, 142. https://doi.org/10.1186/1471-2393-13-142

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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/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.",

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T2 - Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial – study protocol

AU - Jelsma, Judith G M

AU - van Poppel, Mireille N M

AU - Galjaard, Sander

AU - Desoye, Gernot

AU - Corcoy, Rosa

AU - Devlieger, Roland

AU - van Assche, Andre

AU - Timmerman, Dirk

AU - Jans, Goele

AU - Harreiter, Jurgen

AU - Kautzky-Willer, Alexandra

AU - Damm, Peter

AU - Mathiesen, Elisabeth R

AU - Jensen, Dorte Kold

AU - Andersen, Liselotte

AU - Dunne, Fidelma

AU - Lapolla, Annunziata

AU - Di Cianni, Graziano

AU - Bertolotto, Alessandra

AU - Wender-Oegowska, Ewa

AU - Zawiejska, Agnieszka

AU - Blumska, Kinga

AU - Hill, David

AU - Rebollo, Pablo

AU - Snoek, Frank J

AU - Simmons, David

PY - 2013/7/5

Y1 - 2013/7/5

N2 - 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.

AB - 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.

U2 - 10.1186/1471-2393-13-142

DO - 10.1186/1471-2393-13-142

M3 - Journal article

C2 - 23829946

SN - 1471-2393

VL - 13

JO - B M C Pregnancy and Childbirth

JF - B M C Pregnancy and Childbirth

M1 - 142

ER -

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

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