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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05634837
Enrollment
40
Registered
2022-12-02
Start date
2019-05-31
Completion date
2023-01-13
Last updated
2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

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.

Interventions

BEHAVIORALDecision Support System counseling

Decision Support System counseling to improve diet and lifestyle in pregnancy

Counseling to improve diet and lifestyle in pregnancy

Sponsors

Iaso Maternity Hospital, Athens, Greece
CollaboratorOTHER
Harokopio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy pregnant women over 18 years

Exclusion criteria

* any metabolic disorder

Design outcomes

Primary

MeasureTime frameDescription
Change in the Mediterranean diet adherence3 monthsDifferences in MedDiet adherence will be assessed by MedDiet score.

Secondary

MeasureTime frameDescription
Changes in anthropometric parameters3 monthsChanges in fat free mass (%) assessed by bioelectrical impedance
Changes in blood parameters3 monthsChanges in blood lipids measured in a biochemical analyzer
Changes in dietary intake3 monthsChanges in nutrient intake estimated by the nutritionist Pro analysis of 24h recalls
Changes in Hospital Anxiety and Depression Scale3 monthsChanges 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

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026