Increase in MedDiet Adherence in Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Behavioral: Decision Support System counseling; Behavioral: Standard nutritional counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 17671
    • Andriana Kaliora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• healthy pregnant women over 18 years

Exclusion Criteria:

• any metabolic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Decision Support System counseling; Decision Support System counseling to improve diet and lifestyle in pregnancy
Other: Standard nutritional counseling; Participants of the Control group did not have access to CDSS and only received general lifestyle guidelines.	Behavioral: Standard nutritional counseling; Counseling to improve diet and lifestyle in pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Mediterranean diet adherence	Differences in MedDiet adherence will be assessed by MedDiet score.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in anthropometric parameters	Changes in fat free mass (%) assessed by bioelectrical impedance	3 months
Changes in blood parameters	Changes in blood lipids measured in a biochemical analyzer	3 months
Changes in dietary intake	Changes in nutrient intake estimated by the nutritionist Pro analysis of 24h recalls	3 months
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

Collaborators and Investigators

• Sponsor: Harokopio University
• Collaborators: Iaso Maternity Hospital, Athens, Greece
• Investigators: Study Director: Andriana C. Kaliora, Harokopio University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2019
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: PREGNANT_MEDDIET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No