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

8 september 2026 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

144

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

10 mars 2027

Avslutad studie (Beräknad)

10 april 2027

Studieregistreringsdatum

Först inskickad

11 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

19 augusti 2026

Första postat (Faktisk)

21 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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