Polycystic Ovary SyndromeNCT06380010
Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome
A study testing Mediterranean diet group in people with Polycystic Ovary Syndrome, run by Iaso Maternity Hospital, Athens, Greece at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Mediterranean diet group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Dec 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Newly diagnosed with PCOS females <18 years of age.
- Females with guardians who provided signed participation consent.
Who cannot join
- Females ≥18 years of age.
- 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.
- Pregnant or lactating females.
- Females diagnosed with alcoholism or drug addiction.
- Females being under any drug treatment.
- 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.
- Females with guardians non able to read and understand the consent information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Dietary Habits in Adolescents With Polycystic Ovary Syndrome: Personalized Mediterranean Diet Intervention Via Clinical Decision Support System. A Randomized Controlled Trial
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.
Read the detailed description
The aim of the present randomised controlled trial was to investigate the effects of a Mediterranean Diet (MD) intervention delivered through a Clinical Decision Support System (CDSS) on various dietary, health parameters and anxiety in adolescent females, aged 15-17 years, with PCOS. A randomized controlled trial was conducted with 40 adolescent females diagnosed with PCOS, randomly assigned to either an Intervention group (IG) (n=20) or a Control group (CG) (n=20). The IG received personalized dietary guidance based on the MD principles, delivered through a CDSS, while the CG received general nutritional advice. Measurements of dietary intake, anthropometric indices, biochemical markers, and psychological well-being were collected at baseline and after a 3-month intervention period. After 3 months, significant improvements were observed in the IG compared to the CG. Adherence to the MD increased significantly in the IG, leading to decreased caloric intake, fat, saturated fatty acids, and dietary cholesterol, and increased intake of monounsaturated fatty acids. Conversely, the CG experienced an increase in fat and dietary cholesterol intake. Both groups exhibited an increase in fiber intake, with a more pronounced rise observed in the MD group. Psychological well-being showed a significant reduction in anxiety levels in the IG group, while no significant change was observed in the CG. The intervention led to improvements in dietary patterns, body composition, and psychological well-being. These results underscore the importance of dietary interventions tailored to the MD principles in the management of PCOS among adolescent females.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Mediterranean diet group
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet groupOther
Females who met the inclusion and exclusion criteria were allocated in groups of one to either the Control group or the Intervention (MD) group using a random assignment method applied by an independent statistician. During the trial, every participant in both groups had two individual sessions with the assigned researchers. These sessions took place at the beginning of the trial and three months later, and involved anthropometry measurements, evaluation of dietary habits, assessment of psychological well-being, and collection of blood samples. Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | 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. Receives: Other: Mediterranean diet group |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherance to the Mediterranean diet
Adherance was assessed with the Kidmed score
Measured: 3 months
Secondary outcomes (1)
Improvement of psychological well-being
Psychological well-being was assessed by the Hospital Anxiety-Depression Scale (HADS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Dec 2019
- Primary completion31 Mar 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruitment involved adolescents with polycystic ovary syndrome. Participants, who expressed their willingness to take part, attended personal meetings with the appointed dieticians who provided comprehensive explanations on the objectives, methods, and the potential benefits/risks of the study. A leaflet with related information was provided to all patients. Every eligible volunteer, and their guardian, signed a written informed consent and then kept a hard copy of the signed document. All eligible females were recruited in 12/2019 and were randomly allocated in groups of one to either the Control group (CG) or the Intervention group (IG). The IG received a personalized Mediterranean dietary plan, delivered through a clinical decision support system, while the CG received general dietary advice. Every participant had two individual sessions with the assigned dietician, at the beginning and at the trial endpoint, which involved anthropometry, dietary assessment, and blood withdrawal.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iaso Maternity Hospital, Athens, Greece
- Sponsor type
- University, hospital or other
- Collaborators
- Harokopio University, University of Peloponnese
- Responsible party
- Principal investigator, Panos Papandreou, Iaso Maternity Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380010
- Sponsor's protocol ID
- IASO HOSPITAL (ATHENS-GREECE)
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foscolou 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.
PubMed 38929215
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Dietary Habits in Adolescents With Polycystic Ovary Syndrome: Personalized Mediterranean Diet Intervention Via Clinical Decision Support System. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06380010
- Acronym / sponsor ID
- IASO HOSPITAL (ATHENS-GREECE)
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Iaso Maternity Hospital, Athens, GreeceUniversity, hospital or other
- Collaborators
- Harokopio University, University of Peloponnese
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of the present randomised controlled trial was to investigate the effects of a Mediterranean Diet (MD) intervention delivered through a Clinical Decision Support System (CDSS) on various dietary, health parameters and anxiety in adolescent females, aged 15-17 years, with PCOS. A randomized controlled trial was conducted with 40 adolescent females diagnosed with PCOS, randomly assigned to either an Intervention group (IG) (n=20) or a Control group (CG) (n=20). The IG received personalized dietary guidance based on the MD principles, delivered through a CDSS, while the CG received general nutritional advice. Measurements of dietary intake, anthropometric indices, biochemical markers, and psychological well-being were collected at baseline and after a 3-month intervention period. After 3 months, significant improvements were observed in the IG compared to the CG. Adherence to the MD increased significantly in the IG, leading to decreased caloric intake, fat, saturated fatty acids, and dietary cholesterol, and increased intake of monounsaturated fatty acids. Conversely, the CG experienced an increase in fat and dietary cholesterol intake. Both groups exhibited an increase in fiber intake, with a more pronounced rise observed in the MD group. Psychological well-being showed a significant reduction in anxiety levels in the IG group, while no significant change was observed in the CG. The intervention led to improvements in dietary patterns, body composition, and psychological well-being. These results underscore the importance of dietary interventions tailored to the MD principles in the management of PCOS among adolescent females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Recruitment involved adolescents with polycystic ovary syndrome. Participants, who expressed their willingness to take part, attended personal meetings with the appointed dieticians who provided comprehensive explanations on the objectives, methods, and the potential benefits/risks of the study. A leaflet with related information was provided to all patients. Every eligible volunteer, and their guardian, signed a written informed consent and then kept a hard copy of the signed document. All eligible females were recruited in 12/2019 and were randomly allocated in groups of one to either the Control group (CG) or the Intervention group (IG). The IG received a personalized Mediterranean dietary plan, delivered through a clinical decision support system, while the CG received general dietary advice. Every participant had two individual sessions with the assigned dietician, at the beginning and at the trial endpoint, which involved anthropometry, dietary assessment, and blood withdrawal.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Other: Mediterranean diet groupEach 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newly diagnosed with PCOS females <18 years of age.
- Females with guardians who provided signed participation consent.
Key exclusion criteria (7 listed)
- Females ≥18 years of age.
- 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.
- Pregnant or lactating females.
- Females diagnosed with alcoholism or drug addiction.
- Females being under any drug treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean diet groupFemales who met the inclusion and exclusion criteria were allocated in groups of one to either the Control group or the Intervention (MD) group using a random assignment method applied by an independent statistician. During the trial, every participant in both groups had two individual sessions with the assigned researchers. These sessions took place at the beginning of the trial and three months later, and involved anthropometry measurements, evaluation of dietary habits, assessment of psychological well-being, and collection of blood samples. Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes. | Other | Intervention Group |
Primary outcome
Adherance to the Mediterranean diet
Time frame: 3 months
Adherance was assessed with the Kidmed score
1 secondary outcome
Improvement of psychological well-being
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 38929215Foscolou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet group in people with Polycystic Ovary Syndrome, run by Iaso Maternity Hospital, Athens, Greece at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherance to the Mediterranean diet (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06380010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.