Funding for this research was provided by:
Canadian Institutes of Health Research (FRN 123347)
Dairy Research Cluster Initiative (AIP-CL04)
Received: 14 April 2018
Accepted: 21 November 2018
First Online: 19 December 2018
Ethics approval and consent to participate
: After independent, full, external peer review the study protocol and subsequent amendments have been approved by the Hamilton Integrated Research Ethics Board (REB Project no. 12–469, McMaster University and its associated sites, Hamilton, ON), the Joseph Brant Hospital Research Ethics Committee (Project titled “Be Healthy in Pregnancy (B-HIP): An RCT to study nutrition and exercise approaches for healthy pregnancy,” Joseph Brant Hospital, Burlington, ON), and the Health Sciences Research Ethics Board (HSREB File no. 103272, Western University and its associated sites, London, ON). This study is being conducted in compliance with the protocol, Good Clinical Practice and the applicable regulatory requirements.The Research Ethics boards have approved changes to the protocol since the inception of the clinical trial. All changes were communicated to relevant parties and modified on the trial registries. Of significance, the inclusion criteria was modified: increasing BMI from 30 to 40 kg/m<sup>2</sup> to capture a representative sample of the community who presents an important percentage of obese women; participants have to be randomized to group allocation before 17 weeks 6 days (initially set at 11 weeks 6 days) to maximize participant enrolment while ensuring an intervention period of at least 20 weeks. Further, two groups originally excluded were added to the inclusion criteria: women whose pregnancy is a result of in vitro fertilization and women currently breastfeeding from a previous pregnancy. Exclusion criteria were also modified to redefine exclusion of participants with a prenatal depression score > 12 (rather than the initial score of 10) on the validated Edinburgh Depression scale as that is indicative of severe depression and should be referred for treatment.
: Not applicable.
: The authors declare that they have no competing interests.
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