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Completed

NCT Number: NCT05634837

Increase in MedDiet Adherence in Pregnancy

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Andriana Kaliora

Athens, 17671, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy pregnant women over 18 years

Exclusion criteria

  • any metabolic disorder

Treatment and study plan

Decision Support System counseling

Behavioral

Decision Support System counseling to improve diet and lifestyle in pregnancy

Standard nutritional counseling

Behavioral

Counseling to improve diet and lifestyle in pregnancy

Primary outcomes

  1. Change in the Mediterranean diet adherence

    Time frame: 3 months

    Differences in MedDiet adherence will be assessed by MedDiet score.

Secondary outcomes

  1. Changes in anthropometric parameters

    Time frame: 3 months

    Changes in fat free mass (%) assessed by bioelectrical impedance

  2. Changes in blood parameters

    Time frame: 3 months

    Changes in blood lipids measured in a biochemical analyzer

  3. Changes in dietary intake

    Time frame: 3 months

    Changes in nutrient intake estimated by the nutritionist Pro analysis of 24h recalls

  4. Changes in Hospital Anxiety and Depression Scale

    Time frame: 3 months

    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

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Collaborators

  • Iaso Maternity Hospital, Athens, Greece

Registry information

Official study title

Application of Clinical Decision Support System to Assist Pregnant Women to Increase Mediterranean Diet Adherence : A Randomised Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Dec 2, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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