EHBM-Based Intervention for Polycystic Ovarain Syndrome Among High Female School Students (EHBM-PCOSHSFS)
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Salwan Abed Laftah, PhD
- Phone Number: +9467816193527
- Email: solwan.abd1206a@conursing.uobaghdad.edu.iq
Study Locations
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Iraq
- University of Baghdad
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Contact:
- Salwan Abed Laftah, PhD
- Phone Number: +9467816193527
- Email: solwan.abd1206a@conursing.uobaghdad.edu.iq
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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No Intervention: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors
Time Frame: 6 months
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Polycystic Ovarain Syndrome
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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