Polycystic Ovarian SyndromeEHBM-PCOSHSFSNCT07780214
EHBM-Based Intervention for Polycystic Ovarain Syndrome Among High Female School Students
A study testing Expanded health belief model based behavioural intervention for polycystic ovarain syndrome in people with Polycystic Ovarian Syndrome, run by Salwan Abed Laftah at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- Expanded health belief model based behavioural intervention for polycystic ovarain syndrome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2026to 10 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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%).
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
University of Baghdad
Baghdad, Baghdad Governorate
Salwan Abed Laftah, PhD, +9467816193527, solwan.abd1206a@conursing.uobaghdad.edu.iq
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Expanded health belief model based behavioural intervention for polycystic ovarain syndrome
- Keywords
- Expanded Health Belief Model, Polycystic Ovarian Syndrome, Randomized Controlled Trial
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded health belief model based behavioural intervention for polycystic ovarain syndromeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Expanded health belief model based behavioural intervention for polycystic ovarain syndrome |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion10 Mar 2027 (estimated)
- Study completion10 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salwan Abed Laftah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salwan Abed Laftah, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780214
- Sponsor's protocol ID
- Polycystic Ovarain Syndrome
- Acronym
- EHBM-PCOSHSFS
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared because the data contain potentially identifiable and sensitive information collected from adolescent participants.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07780214
- Acronym / sponsor ID
- EHBM-PCOSHSFS / Polycystic Ovarain Syndrome
- Conditions
- Polycystic Ovarian Syndrome
- Keywords
- Expanded Health Belief Model, Polycystic Ovarian Syndrome, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Salwan Abed LaftahUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 Apr 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Expanded health belief model based behavioural intervention for polycystic ovarain syndromethe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expanded health belief model based behavioural intervention for polycystic ovarain syndromeThis 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. | Behavioural | Experimental |
Primary outcome
Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Improving diet quality among adolescents, using health belief model in a collaborative learning context: a randomized field trial study."Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared because the data contain potentially identifiable and sensitive information collected from adolescent participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded health belief model based behavioural intervention for polycystic ovarain syndrome in people with Polycystic Ovarian Syndrome, run by Salwan Abed Laftah at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salwan Abed Laftah, PhD (+9467816193527, solwan.abd1206a@conursing.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Polycystic Ovary Syndrome Health-Protective Behaviors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.