Increase in MedDiet Adherence in Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Related

Intervention / Treatment
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* Behavioral: Decision Support System counseling
* Behavioral: Standard nutritional counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy pregnant women over 18 years Exclusion Criteria: any metabolic disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |