Increase in MedDiet Adherence in Pregnancy

Harokopio University

Status: Completed

Conditions: Pregnancy Related

Treatments: Behavioral: Standard nutritional counseling; Behavioral: Decision Support System counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT05634837

PREGNANT_MEDDIET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy pregnant women over 18 years

Exclusion criteria

• any metabolic disorder

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Decision Support System counseling

Experimental group

Description:

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.

Treatment:

Behavioral: Decision Support System counseling

Standard nutritional counseling

Other group

Description:

Participants of the Control group did not have access to CDSS and only received general lifestyle guidelines.

Treatment:

Behavioral: Standard nutritional counseling