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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05634837
Other study ID # PREGNANT_MEDDIET
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2019
Est. completion date January 13, 2023

Study information

Verified date May 2023
Source Harokopio University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 13, 2023
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - healthy pregnant women over 18 years Exclusion Criteria: - any metabolic disorder

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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

Locations

Country Name City State
Greece Andriana Kaliora Athens

Sponsors (2)

Lead Sponsor Collaborator
Harokopio University Iaso Maternity Hospital, Athens, Greece

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Mediterranean diet adherence Differences in MedDiet adherence will be assessed by MedDiet score. 3 months
Secondary Changes in anthropometric parameters Changes in fat free mass (%) assessed by bioelectrical impedance 3 months
Secondary Changes in blood parameters Changes in blood lipids measured in a biochemical analyzer 3 months
Secondary Changes in dietary intake Changes in nutrient intake estimated by the nutritionist Pro analysis of 24h recalls 3 months
Secondary Changes in Hospital Anxiety and Depression Scale Changes in well-being by applying a self-assessment scale (the Hospital Anxiety and Depression Scale) that comprises 14 items. Women with scores above 7 were at risk of having anxiety or depressive disorders 3 months
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