Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome

NCT06380010 | Completed

• 1 other identifier: IASO HOSPITAL (ATHENS-GREECE)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Adherance to the Mediterranean diet

  Adherance was assessed with the Kidmed score

  3 months

Secondary Outcomes (1)

• Improvement of psychological well-being

  3 months

Study Arms (2)

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.

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.

Interventions

Mediterranean diet group OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 15 Years - 17 Years
• Gender Eligibility Details: sex was biologically identified
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newly diagnosed with PCOS females \<18 years of age.
• Females with guardians who provided signed participation consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iaso Maternity Hospital, Athens, Greece: lead
• Harokopio University: collaborator
• University of Peloponnese: collaborator

Study Sites (1)

IASO Hospital

Athens, 15123, Greece

Location

Related Publications (1)

• 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.

  PMID: 38929215 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Treatment allocation was not revealed to the appointed statistician until the end of the study and release of the final outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maria Skouroliakou, Associate of Professor in Harokopio University of Athens

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: December 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: June 30, 2020
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)