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EHBM-Based Intervention for Polycystic Ovarain Syndrome Among High Female School Students (EHBM-PCOSHSFS)

8 settembre 2026 aggiornato da: Salwan Abed Laftah

Efficacy of The Expanded Health Belief Model-Based Intervention in Enhancing Female High School Students' Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors: A Randomized Controlled Trial

This study aims to examine efficacy of The Expanded Health Belief model-based intervention in enhancing female high school students' adherence to polycystic ovary syndrome health-protective behaviors.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The study will involve female high school students and use a Randomized Controlled Trial (RCT) design. Participants will be randomly assigned to an intervention group receiving an educational/behavioral program based on the Expanded Health Belief Model, and a control group receiving usual or routine information.

The intervention will aim to improve students':

Knowledge and awareness about PCOS Perceived susceptibility and severity of PCOS Perceived benefits and barriers to preventive behaviors Self-efficacy and motivation Adherence to healthy behaviors, such as healthy eating, regular physical activity, weight management, and appropriate health-seeking behaviors The effectiveness of the intervention will be assessed by comparing changes in PCOS-related health-protective behaviors between the intervention and control groups.

Tipo di studio

Interventistico

Iscrizione (Stimato)

144

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Female high school students enrolled in the selected schools during the study period.
  • Be within the predefined age range specified in the research protocol (for example, 15-18 years).
  • Be able to read and understand the language used in the intervention and questionnaires.
  • Be willing to participate in the study.
  • Have no previously diagnosed PCOS.
  • Not be currently participating in another structured lifestyle or PCOS educational intervention.

Exclusion Criteria:

  • Have a previously diagnosed PCOS.
  • Have a medical condition that prevents or significantly limits physical activity recommended in the intervention.
  • Have a cognitive, learning, or communication difficulty that prevents them from understanding the intervention or completing the questionnaire.
  • Are currently participating in another structured lifestyle, weight-management, or PCOS educational program.
  • Are receiving a treatment or intervention that could substantially influence the study outcomes.
  • Are absent from a predetermined proportion of intervention sessions (for example, more than 20%-25%).
  • Fail to complete the baseline assessment or required post-intervention assessment.
  • Withdraw their consent/assent at any stage of the study.
  • Become unavailable because of transfer to another school, prolonged absence, or other circumstances that prevent completion of the

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental

the experimental group consists of female high school students who are randomly assigned to receive the Expanded Health Belief Model (EHBM)-based intervention.

The intervention is designed to improve their understanding of Polycystic Ovary Syndrome (PCOS) and encourage them to adopt and maintain health-protective behaviors.

The experimental group would receive a structured educational/behavioral program addressing the major components of the EHBM, such as:

Perceived susceptibility: Helping students understand their potential risk factors for PCOS.

Perceived severity: Increasing awareness of the possible health consequences of PCOS.

Perceived benefits: Explaining the benefits of healthy behaviors in preventing or reducing PCOS-related risks.

Perceived barriers: Identifying and overcoming obstacles to healthy eating, physical activity, and other protective behaviors.

Self-efficacy: Building students' confidence in their ability to practice healthy behaviors.
Comportamentale: Expanded health belief model based behavioural intervention for polycystic ovarain syndrome
This is a non-pharmacological, behavioral intervention designed to enhance adherence to polycystic ovary syndrome (PCOS) health-protective behaviors among female high school students. The intervention is based on the Expanded Health Belief Model and consists of structured educational and behavioral sessions addressing key determinants of preventive health behaviors. The intervention includes education about PCOS, increasing perceived susceptibility and severity, emphasizing the benefits of health-protective behaviors, identifying and reducing perceived barriers, enhancing self-efficacy, providing cues to action, and strengthening health motivation. Practical guidance on healthy dietary practices, regular physical activity, healthy weight management, and appropriate health-seeking behaviors is also provided to support participants in adopting and maintaining PCOS health-protective behaviors.
Nessun intervento: Control group

If by "non-interventional group" you mean the control group in your randomized controlled trial, it is the group that does not receive the Expanded Health Belief Model (EHBM)-based intervention.

Control (Non-intervention) Group The control group consists of female high school students who are randomly assigned not to receive the specific EHBM-based educational intervention during the study period.

They may continue to receive their usual school health education or routine information about general health, depending on the study protocol.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors
Lasso di tempo: 6 months

Number of female high school students who would adhere to Polycystic Ovary Syndrome Health-Protective Behaviors as measured by the Behavioral Intention Scale to Adhere to Polycystic Ovary Syndrome Health-Protective Behaviors.

The data will be collected using a self-reported tool. The Behavioral Intention Scale to Adhere to Polycystic Ovary Syndrome Health-Protective Behaviors includes the Dietary Intention subscale which encompasses 3 items (it ranges between 3-15).

The Physical Activity Intention Subscale which encompasses 2 items (it ranges between 2-10).

The Medical Engagement and Monitoring Intentions which encompasses 3 items (it ranges between 3-15).

All these items are measured on a 5-point Likert scale.
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Salwan Abed Laftah

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

10 marzo 2027

Completamento dello studio (Stimato)

10 aprile 2027

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 agosto 2026

Primo Inserito (Effettivo)

21 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Polycystic Ovarain Syndrome

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data (IPD) will not be publicly shared because the data contain potentially identifiable and sensitive information collected from adolescent participants.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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