Increase in MedDiet Adherence in Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Behavioral: Standard nutritional counseling; Behavioral: Decision Support System counseling

• Registration Number: NCT05634837
• Lead Sponsor: Harokopio University

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.

Study Timeline

• Study Start: 2019-05-31
• Primary Completion: 2022-05-31
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-23
• Study First Posted: 2022-12-02
• Study Completion: 2023-01-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• healthy pregnant women over 18 years

Exclusion Criteria

• any metabolic disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard nutritional counseling	Standard nutritional counseling	Participants of the Control group did not have access to CDSS and only received general lifestyle guidelines.
Decision Support System counseling	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.

Primary Outcome Measures

Name	Time	Method
Change in the Mediterranean diet adherence	3 months	Differences in MedDiet adherence will be assessed by MedDiet score.

Secondary Outcome Measures

Name	Time	Method
Changes in anthropometric parameters	3 months	Changes in fat free mass (%) assessed by bioelectrical impedance
Changes in blood parameters	3 months	Changes in blood lipids measured in a biochemical analyzer
Changes in Hospital Anxiety and Depression Scale	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
Changes in dietary intake	3 months	Changes in nutrient intake estimated by the nutritionist Pro analysis of 24h recalls

Trial Locations

Locations (1)

Andriana Kaliora; 🇬🇷 Athens, Greece