Clinical trial NCT05634837: Increase in MedDiet Adherence in Pregnancy
Official title: Application of Clinical Decision Support System to Assist Pregnant Women to Increase Mediterranean Diet Adherence : A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: Iaso Maternity Hospital, Athens, Greece
First posted: 2022-12-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* healthy pregnant women over 18 years

Exclusion Criteria:

* any metabolic disorder

Primary outcomes:
measure: Change in the Mediterranean diet adherence
timeFrame: 3 months
Secondary outcomes:
measure: Changes in anthropometric parameters
timeFrame: 3 months
measure: Changes in blood parameters
timeFrame: 3 months
measure: Changes in dietary intake
timeFrame: 3 months
measure: Changes in Hospital Anxiety and Depression Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Andriana Kaliora
Study officials:
affiliation: HAROKOPIO UNIVERSITY OF ATHENS
name: Andriana C. Kaliora
role: STUDY_DIRECTOR
References: