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

8 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

144

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Salwan Abed Laftah

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

10 maart 2027

Studie voltooiing (Geschat)

10 april 2027

Studieregistratiedata

Eerst ingediend

11 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 augustus 2026

Eerst geplaatst (Werkelijk)

21 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Polycystic Ovarain Syndrome

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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