NCT05634837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2023

Completed
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

November 8, 2022

Last Update Submit

May 17, 2023

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Change in the Mediterranean diet adherence

    Differences in MedDiet adherence will be assessed by MedDiet score.

    3 months

Secondary Outcomes (4)

  • Changes in anthropometric parameters

    3 months

  • Changes in blood parameters

    3 months

  • Changes in dietary intake

    3 months

  • Changes in Hospital Anxiety and Depression Scale

    3 months

Study Arms (2)

Decision Support System counseling

EXPERIMENTAL

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

Standard nutritional counseling

OTHER

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

Behavioral: Standard nutritional counseling

Interventions

Decision Support System counselingBEHAVIORAL

Decision Support System counseling to improve diet and lifestyle in pregnancy

Decision Support System counseling
Standard nutritional counselingBEHAVIORAL

Counseling to improve diet and lifestyle in pregnancy

Standard nutritional counseling

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women were eligible for the study
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy pregnant women over 18 years

You may not qualify if:

  • any metabolic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andriana Kaliora

Athens, 17671, Greece

Location

Study Officials

  • Andriana C. Kaliora

    HAROKOPIO UNIVERSITY OF ATHENS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 8, 2022

First Posted

December 2, 2022

Study Start

May 31, 2019

Primary Completion

May 31, 2022

Study Completion

January 13, 2023

Last Updated

May 18, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)