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.
