Increase in MedDiet Adherence in Pregnancy
Condition: Pregnancy Related
Study type: Interventional

Summary: 
      In the present randomised-controlled 3-month dietary intervention, we aim to a) increase
      Mediterranean diet adherence among apparently healthy pregnant women with the support of
      CDSS, and b) assess nutritional status and psychological parameters (anxiety and depression).
      To our knowledge, this is the first attempt investigating the effectiveness of CDSS in
      Mediterranean diet adherence of pregnant women.
    

Detailed description: 
      In this two-armed, single center, randomised controlled 3-month trial, apparently healthy
      pregnant women are randomly assigned to either the Control or the Intervention arm. The
      appointed statistician applies simple randomisation through a computer-generated
      randomization sequence. Treatment allocation is exposed to the statistician only after the
      assessment of outcomes.

      At baseline before the start of the trial, each enrolled participant is appointed to a
      well-experienced dietician. In the Intervention group (CDSS group), women receive a
      personalised daily dietary plan based on the Mediterranean diet and according to
      participant's needs, habits and preferences. All elements needed for the synthesis of the
      dietary plan i.e., gestational age, body mass index (BMI) before the fetus conception, daily
      total energy expenditure, physical activity level based on the concept of metabolic
      equivalent of task (MET), caloric needs according to nutritional status, and macronutrient
      distribution are calculated using the CDSS database. The CDSS-dietary regimen consists of a
      daily eating program that was renewed every 15 days, paired with nutritional recommendations
      that are in line with the "National Dietary Guidelines for Pregnancy"
      [http://www.diatrofikoiodigoi.gr/?page=summary-women].

      Before the start of the trial, women are trained to use the CDSS and receive individual login
      passwords. On a weekly basis, participants are instructed to input a 3-day food diary in the
      CDSS, made automatically available to the dieticians. When entering the CDSS, women monitor
      their personal goals i.e., body weight, physical activity, consumption of fruits and
      vegetables. Every other week, phone interviews are also performed to support nutritional and
      lifestyle consultation. Additionally, unexpected phone calls are made to obtain 24-hour
      dietary recalls.

      Participants of the Control group do not have access to CDSS and only received general
      lifestyle guidelines based on the "National Dietary Guidelines for Pregnancy" via scheduled
      phone calls every 15 days with the appointed dietician. Women of the Control group are
      instructed to keep a 3-day food diary every week, sent by e-mail to the appointed dietician.
      Again, unexpected phone calls are made to obtain 24-hour dietary recalls.
    

Intervention name(s): Decision Support System counseling; Standard nutritional counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Decision Support System counseling to improve diet and lifestyle in pregnancy; Counseling to improve diet and lifestyle in pregnancy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research