Clinical trial · Interventional
Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome
Optimizing Dietary Habits in Adolescents With Polycystic Ovary Syndrome: Personalized Mediterranean Diet Intervention Via Clinical Decision Support System. A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean diet group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intervention Group
- description
- Each participant was assigned to a highly skilled dietician. The dietician implemented an individualized daily dietary regimen according to the Mediterranean diet produced by the clinical decision support system (CDSS) software. The CDSS was utilized to calculate all necessary components for the synthesis of the dietary plan, which was renewed every 15 days. Participants of the Intervention group obtained unique login credentials for the CDSS and received instruction on its operation from the designated dietitians. They were directed to access their CDSS account remotely on a weekly basis in order to monitor their nutritional status (body weight and healthy eating) and to complete a three-day dietary journal; this information was automatically accessible to the dietitians. Telephone interviews were conducted every other week in order to supplement the nutritional and lifestyle consultations. In addition, unanticipated phone calls requesting 24-hour dietary recalls were received.
- interventionNames
- Other: Mediterranean diet group
- type
- NO_INTERVENTION
- label
- Control Group
- description
- The Control group participants were not provided with CDSS. They simply got basic lifestyle instructions based on the "National Dietary Guidelines for Children and Adolescents" during phone call sessions with the dieticians every 15 days. The ladies in the Control group were directed to maintain a food diary for three consecutive days each week, which they then transmitted to the designated dietician via email. Once again, unsolicited phone calls were conducted in order to acquire 24-hour dietary recalls.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: 1. Newly diagnosed with PCOS females \<18 years of age. 2. Females with guardians who provided signed participation consent. Exclusion Criteria: 1. Females ≥18 years of age. 2. Females suffering from severe illnesses (i.e., organ failure, autoimmune diseases, congenital metabolic disorders), psychiatric disease or with emerging health issues that could hinder the trial. 3. Pregnant or lactating females. 4. Females diagnosed with alcoholism or drug addiction. 5. Females being under any drug treatment. 6. Females followed a specific type of diet within the past 5 years or have used nutrient or non-nutrient supplements within the last 6 months. 7. Females with guardians non able to read and understand the consent information.
References
Publications (1)
- DERIVEDFoscolou A, Papandreou P, Gioxari A, Skouroliakou M. Optimizing Dietary Habits in Adolescents with Polycystic Ovary Syndrome: Personalized Mediterranean Diet Intervention via Clinical Decision Support System-A Randomized Controlled Trial. Children (Basel). 2024 May 24;11(6):635. doi: 10.3390/children11060635. PMID 38929215