2.2. Study Design
Eligible women were randomly assigned in blocks of one to either the control arm or the intervention arm. Researchers and patients were aware of the treatment allocation, except for the appointed statistician, who was blinded. The statistician applied simple randomisation through a computer-generated randomisation sequence, and the randomisation list was available only to the principal investigator.Throughout the trial, each enrolled subject from both groups attended two personal sessions with the appointed researchers, at baseline and at follow-up (3 months later), during which anthropometry, dietary assessment, and blood withdrawal were performed. More specifically, at baseline, before the start of the trial, each participant was appointed to a well-experienced dietician. In the intervention group (the CDSS group), the dietician administered a personalised daily dietary plan based on the MD that was generated by the CDSS software, according to the participant’s needs, habits, and preferences. All components needed for the dietary plan synthesis, i.e., current and pre-pregnancy body weight, basal metabolic range (BMR), physical activity level based on the concept of metabolic equivalent of task (MET), gestational age, as well as macronutrient distribution, were calculated using the CDSS database as previously described [Participants in the control group did not have access to CDSS and only received general lifestyle guidelines based on the “National Dietary Guidelines for Pregnancy” through phone call sessions with the dieticians every 15 days. The women in the control group were instructed to keep a 3 day food diary every week, which was sent by email to the appointed dietician. Again, unexpected phone calls were made to obtain 24 h dietary recalls.