Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-05-31
2023-01-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Decision Support System counseling
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.
Decision Support System counseling
Decision Support System counseling to improve diet and lifestyle in pregnancy
Standard nutritional counseling
Participants of the Control group did not have access to CDSS and only received general lifestyle guidelines.
Standard nutritional counseling
Counseling to improve diet and lifestyle in pregnancy
Interventions
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Decision Support System counseling
Decision Support System counseling to improve diet and lifestyle in pregnancy
Standard nutritional counseling
Counseling to improve diet and lifestyle in pregnancy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
FEMALE
Yes
Sponsors
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Iaso Maternity Hospital, Athens, Greece
OTHER
Harokopio University
OTHER
Responsible Party
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Andriana C Kaliora
Associate Professor
Principal Investigators
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Andriana C. Kaliora
Role: STUDY_DIRECTOR
HAROKOPIO UNIVERSITY OF ATHENS
Locations
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Andriana Kaliora
Athens, , Greece
Countries
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Other Identifiers
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PREGNANT_MEDDIET
Identifier Type: -
Identifier Source: org_study_id
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