Newly Married CouplesNCT07270913
The Effect of a Gender Education Program Based on the Com-B Model Developed for Newlywed Couples and Home Monitoring on Individuals and Families
A study testing information in people with Newly Married Couples and Gender Equality, run by Selma Kahraman.
Trial summary
Introduction and Aims: The family, recognized as the smallest and most powerful social unit that forms society, is an arena where gender roles, gender identities, and inequalities are reproduced and developed. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Newly Married Couples, Gender Equality, COM_B Model
- What is being tested?
- information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Married 1 month ago
- The woman and her husband are literate in Turkish
- Being a housewife
- Growing up in Şanlıurfa and residing in the center
- Authorizing participation.
Who cannot join
- - Married for more than 1 month or single
- Being a working woman
- Not knowing Turkish
- Not living in the center of Şanlıurfa
- Currently participating in any other intervention program
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Introduction and Aims:
The family, recognized as the smallest and most powerful social unit that forms society, is an arena where gender roles, gender identities, and inequalities are reproduced and developed. The establishment, maintenance, and continuation of a healthy marriage is the source of healthy families and, naturally, healthy individuals. Therefore, research on newly married individuals is valuable as it sheds light on future generations. This research began with the question, "How should effective gender education be designed to minimize gender inequality and the problems arising from it?" This research presents a study protocol to evaluate the effectiveness of a gender education program based on the Capacity, Opportunity, and Motivation to Behave (COM-B) model. Furthermore, this study aims to take solid steps in the first stage of family formation through a one-year follow-up of newly married couples and thus create healthy and strong families.
Read more
Method:
This study will be conducted as a two-phase, prospective, single-center, two-group (1:1) parallel design, pre-test-post-test randomized controlled trial. The Capacity, Opportunity, and Motivation Behavior (COM-B) model is a theoretical framework consisting of six components to understand and support behavior change. In the first phase, a gender education program based on the COM-B model (COMBTC) will be developed, and in the second phase, the effectiveness of COMBTC will be evaluated with 100 newly married couples. The sample will consist of 100 couples who have been married for no more than one month and live in central Şanlıurfa, divided into intervention and control groups at a 1:1 ratio. Participants in the intervention group will undergo a 3-week, multi-component education program based on the COM-B model, while participants in the control group will receive routine general advice. Assessments will be conducted at baseline, after the education, and at 6-11 months. Research data will be collected using a personal information form, a healthy family scale, a marital role expectations scale, a marital problem-solving scale, and a family harmony scale. The data will be evaluated using descriptive statistical analyses and relevant tests.
Read the detailed description
Gender-based issues typically manifest as discrimination and equity problems rooted in the different roles and stereotypes that society imposes on women and men. There is ample evidence that gender inequalities and restrictive norms negatively impact health; however, far fewer studies have focused on testing solutions. Identifying individuals' attitudes toward gender equality and potential sexist attitudes and behaviors is not sufficient on its own. In order for these sexist attitudes and behaviors to transform into more egalitarian attitudes, educational programs on gender equality must be designed, implemented, and their effects determined. This is because education is the best tool for bringing about and sustaining change in relation to gender equality. Education has a significant impact on individuals' awareness of gender inequalities in society, the formation of social consciousness regarding gender equality, and ensuring the continuation of this egalitarian structure in democratic societies. Discussions on gender education are intense but fragmented. Therefore, the aim of this research is to conduct a needs analysis regarding the level and content of gender education and to develop recommendations on the level and content of effective education.
In today's society, where divorces and unhappy marriages are rapidly increasing, healthy marriages are more difficult to achieve than in the past. The main reason for this is that societies undergoing rapid change are under pressure from modernism, weakening traditional structures and preventing new behavioral patterns from taking root. In our time, building strong families through healthy marriages has become much more important. The more solid and healthy the foundations of a family are within a community, the more solid and healthy the society formed by that family will be. Healthy generations are raised in a family environment. For this reason, this project focuses on newly married couples who are just starting to build a family. Gender education for newly married individuals, who are at the forefront of the family where gender roles are first observed and gender identities and inequalities are reproduced and developed, plays an important role in overcoming gender-related problems. This study focus on newly married couples, i.e., young people or young adults, also highlights the global opportunity to address gender-based constraints on health and well-being at an early age to ensure that young people benefit from their effects throughout their lives and offers the opportunity to prevent gender-based health inequalities through early intervention. Interventions targeting gender roles in newly married couples continue, but very few address the underlying causes expected for the intervention to be the underlying behavioral change mechanisms expected for the intervention to be effective. To increase the effectiveness of the intervention, new tools in behavioral science, such as the COM-B model (competence, opportunity, motivation, and behavior), have been used to understand behaviors in intervention development.
The main purpose of the COM-B model is to determine what needs to change to create behavioral change and what needs to be done. Behavioral change requires understanding the factors that drive behavior. To address this, researchers Michie and colleagues developed a model called the COM-B model. According to this model, for behavioral change to occur, the individual must have sufficient ability and opportunity, and their motivation must increase (West and Michie, 2020). In the model, to create behavioral change, individuals' abilities and opportunities are identified, their motivation is increased, and behavioral change is created. In the model, ability includes the physical and psychological capacity that the individual possesses to perform the behavior. Opportunity encompasses the physical and social factors that influence an individual's ability to perform the behavior. Motivation is a process that involves the individual's decision-making and implementation for the behavior to occur (West and Michie, 2020; Ögel and Şimşek, 2023). There are nine intervention initiatives around the center to implement the model: education, persuasion, encouragement, coercion, instruction, restrictions, environmental restructuring, modeling, and activation. Education ensures that the person's level of knowledge is increased. Persuasion is the use of communication to change the person's feelings about the behavior and to bring about behavioral change. Incentives reward the person for behavioral change. Pressure creates the expectation of punishment or penalty. Restrictions involve using rules to create change in the target behavior. Environmental restructuring involves changing the physical and social environment. Instruction involves acquiring and developing skills. Modeling provides a situation for the person to imitate or take as an example. Enabling refers to initiatives that reduce barriers by increasing skills and opportunities. Therefore, the COM-B model can provide a systematic framework for designing and implementing gender education interventions in newly married individuals to increase the effectiveness of intervention programs. This is because there is a lack of evidence on instilling and implementing egalitarian gender roles in newly married individuals, and research is needed to apply the COM-B model to objectively reflect its impact. In this study, numerous strategies and techniques will also be designed and adapted to optimize the gender education program and provide practical evidence, guided by this theoretical model.Improving quality in public health practices is possible by facilitating behavioral change in individuals (Michie et al., 2011). Controlling unhealthy behaviors is considered the ultimate goal of health professionals working in this field. The best way to achieve this goal is to provide services that comprehensively assess the individual's environment and surroundings. One such service is home visits. This is because home visits enable the creation of healthy communities and the provision of comprehensive healthcare in many areas to individuals, families, and community groups. Therefore, home visits are an important initiative in terms of monitoring couples in their environment, addressing all factors, observing mistakes made, and intervening immediately.
- Conditions
- Newly Married Couples, Gender Equality, COM_B Model, Home Monitoring Follow-up, Family Dynamics, Education
- Being tested
- information
- Keywords
- Gender, COM-B Model, Behavior Change, Newly married couples, Family Health, Home monitoring, Family harmony
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
informationBehavioural
Also called Home monitoring
COM-B Gender İnformation
| Study group | Role | What they receive |
|---|---|---|
| Gender education and home monitoring | Experimental | Not described Receives: Behavioral: information |
| 2. Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To ensure the formation of egalitarian role expectations in marriage
Change From Baseline in healthy family scale at 10 month. Change From Baseline in marital role expectations scale at 10 month. Change From Baseline in marital problem-solving scale at 10 month Change From Baseline in family harmony at 10 month
Measured: First 2 months of preparation and education Through study completion, an average of 10 month
Ensuring the formation of egalitarian role expectations in marriage
Research data will be collected using a personal information form, a healthy family scale, a marital role expectations scale, a marital problem-solving scale, and a family harmony scale.
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Married CouplesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selma Kahraman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Selma Kahraman, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270913
- Sponsor's protocol ID
- Date:11.13.2025, No: 2025/354
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Gender Education Program Based on the Com-B Model Developed for Newlywed Couples and Home Monitoring on Individuals and Families
- ClinicalTrials.gov ID
- NCT07270913
- Acronym / sponsor ID
- Date:11.13.2025, No: 2025/354
- Conditions
- Newly Married Couples, Gender Equality, COM_B Model, Home Monitoring Follow-up, Family Dynamics, Education
- Keywords
- Gender, COM-B Model, Behavior Change, Newly married couples, Family Health, Home monitoring, Family harmony
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Selma KahramanUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Dec 2025 (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.
Introduction and Aims:
The family, recognized as the smallest and most powerful social unit that forms society, is an arena where gender roles, gender identities, and inequalities are reproduced and developed. The establishment, maintenance, and continuation of a healthy marriage is the source of healthy families and, naturally, healthy individuals. Therefore, research on newly married individuals is valuable as it sheds light on future generations. This research began with the question, "How should effective gender education be designed to minimize gender inequality and the problems arising from it?" This research presents a study protocol to evaluate the effectiveness of a gender education program based on the Capacity, Opportunity, and Motivation to Behave (COM-B) model. Furthermore, this study aims to take solid steps in the first stage of family formation through a one-year follow-up of newly married couples and thus create healthy and strong families.
Method:
This study will be conducted as a two-phase, prospective, single-center, two-group (1:1) parallel design, pre-test-post-test randomized controlled trial. The Capacity, Opportunity, and Motivation Behavior (COM-B) model is a theoretical framework consisting of six components to understand and support behavior change. In the first phase, a gender education program based on the COM-B model (COMBTC) will be developed, and in the second phase, the effectiveness of COMBTC will be evaluated with 100 newly married couples. The sample will consist of 100 couples who have been married for no more than one month and live in central Şanlıurfa, divided into intervention and control groups at a 1:1 ratio. Participants in the intervention group will undergo a 3-week, multi-component education program based on the COM-B model, while participants in the control group will receive routine general advice. Assessments will be conducted at baseline, after the education, and at 6-11 months. Research data will be collected using a personal information form, a healthy family scale, a marital role expectations scale, a marital problem-solving scale, and a family harmony scale. The data will be evaluated using descriptive statistical analyses and relevant tests.
Detailed description
Gender-based issues typically manifest as discrimination and equity problems rooted in the different roles and stereotypes that society imposes on women and men. There is ample evidence that gender inequalities and restrictive norms negatively impact health; however, far fewer studies have focused on testing solutions. Identifying individuals' attitudes toward gender equality and potential sexist attitudes and behaviors is not sufficient on its own. In order for these sexist attitudes and behaviors to transform into more egalitarian attitudes, educational programs on gender equality must be designed, implemented, and their effects determined. This is because education is the best tool for bringing about and sustaining change in relation to gender equality. Education has a significant impact on individuals' awareness of gender inequalities in society, the formation of social consciousness regarding gender equality, and ensuring the continuation of this egalitarian structure in democratic societies. Discussions on gender education are intense but fragmented. Therefore, the aim of this research is to conduct a needs analysis regarding the level and content of gender education and to develop recommendations on the level and content of effective education.
In today's society, where divorces and unhappy marriages are rapidly increasing, healthy marriages are more difficult to achieve than in the past. The main reason for this is that societies undergoing rapid change are under pressure from modernism, weakening traditional structures and preventing new behavioral patterns from taking root. In our time, building strong families through healthy marriages has become much more important. The more solid and healthy the foundations of a family are within a community, the more solid and healthy the society formed by that family will be. Healthy generations are raised in a family environment. For this reason, this project focuses on newly married couples who are just starting to build a family. Gender education for newly married individuals, who are at the forefront of the family where gender roles are first observed and gender identities and inequalities are reproduced and developed, plays an important role in overcoming gender-related problems. This study focus on newly married couples, i.e., young people or young adults, also highlights the global opportunity to address gender-based constraints on health and well-being at an early age to ensure that young people benefit from their effects throughout their lives and offers the opportunity to prevent gender-based health inequalities through early intervention. Interventions targeting gender roles in newly married couples continue, but very few address the underlying causes expected for the intervention to be the underlying behavioral change mechanisms expected for the intervention to be effective. To increase the effectiveness of the intervention, new tools in behavioral science, such as the COM-B model (competence, opportunity, motivation, and behavior), have been used to understand behaviors in intervention development.
The main purpose of the COM-B model is to determine what needs to change to create behavioral change and what needs to be done. Behavioral change requires understanding the factors that drive behavior. To address this, researchers Michie and colleagues developed a model called the COM-B model. According to this model, for behavioral change to occur, the individual must have sufficient ability and opportunity, and their motivation must increase (West and Michie, 2020). In the model, to create behavioral change, individuals' abilities and opportunities are identified, their motivation is increased, and behavioral change is created. In the model, ability includes the physical and psychological capacity that the individual possesses to perform the behavior. Opportunity encompasses the physical and social factors that influence an individual's ability to perform the behavior. Motivation is a process that involves the individual's decision-making and implementation for the behavior to occur (West and Michie, 2020; Ögel and Şimşek, 2023). There are nine intervention initiatives around the center to implement the model: education, persuasion, encouragement, coercion, instruction, restrictions, environmental restructuring, modeling, and activation. Education ensures that the person's level of knowledge is increased. Persuasion is the use of communication to change the person's feelings about the behavior and to bring about behavioral change. Incentives reward the person for behavioral change. Pressure creates the expectation of punishment or penalty. Restrictions involve using rules to create change in the target behavior. Environmental restructuring involves changing the physical and social environment. Instruction involves acquiring and developing skills. Modeling provides a situation for the person to imitate or take as an example. Enabling refers to initiatives that reduce barriers by increasing skills and opportunities. Therefore, the COM-B model can provide a systematic framework for designing and implementing gender education interventions in newly married individuals to increase the effectiveness of intervention programs. This is because there is a lack of evidence on instilling and implementing egalitarian gender roles in newly married individuals, and research is needed to apply the COM-B model to objectively reflect its impact. In this study, numerous strategies and techniques will also be designed and adapted to optimize the gender education program and provide practical evidence, guided by this theoretical model.Improving quality in public health practices is possible by facilitating behavioral change in individuals (Michie et al., 2011). Controlling unhealthy behaviors is considered the ultimate goal of health professionals working in this field. The best way to achieve this goal is to provide services that comprehensively assess the individual's environment and surroundings. One such service is home visits. This is because home visits enable the creation of healthy communities and the provision of comprehensive healthcare in many areas to individuals, families, and community groups. Therefore, home visits are an important initiative in terms of monitoring couples in their environment, addressing all factors, observing mistakes made, and intervening immediately.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gender education and home monitoring | Experimental | Behavioral: information |
| 2. Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Married 1 month ago
- The woman and her husband are literate in Turkish
- Being a housewife
- Growing up in Şanlıurfa and residing in the center
- Authorizing participation.
Key exclusion criteria (5 listed)
- - Married for more than 1 month or single
- Being a working woman
- Not knowing Turkish
- Not living in the center of Şanlıurfa
- Currently participating in any other intervention program
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 |
|---|---|---|
| informationAlso: Home monitoringCOM-B Gender İnformation | Behavioural | Gender education and home monitoring |
Primary outcome
To ensure the formation of egalitarian role expectations in marriage
Time frame: First 2 months of preparation and education Through study completion, an average of 10 month
Change From Baseline in healthy family scale at 10 month. Change From Baseline in marital role expectations scale at 10 month. Change From Baseline in marital problem-solving scale at 10 month Change From Baseline in family harmony at 10 month
Ensuring the formation of egalitarian role expectations in marriage
Time frame: 10 month
Research data will be collected using a personal information form, a healthy family scale, a marital role expectations scale, a marital problem-solving scale, and a family harmony 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 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Norm, Social, Autonomy
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.
Questions about this trial
What is this clinical trial studying?
A study testing information in people with Newly Married Couples and Gender Equality, run by Selma Kahraman.
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 5 inclusion and 5 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Selma Kahraman, Professor, Doctor (9041431833000 ext. 1620, skahraman1308@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To ensure the formation of egalitarian role expectations in marriage (time frame: First 2 months of preparation and education Through study completion, an average of 10 month). The study lists 2 primary outcomes in all. 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 8 Dec 2025.