NCT07270913

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

November 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

December 8, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 18, 2025

Last Update Submit

November 26, 2025

Conditions

Keywords

GenderCOM-B ModelBehavior ChangeNewly married couplesFamily HealthHome monitoringFamily harmony

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    10 month

Study Arms (2)

Gender education and home monitoring

EXPERIMENTAL
Behavioral: information

2. Control

NO INTERVENTION

Interventions

informationBEHAVIORAL

COM-B Gender İnformation

Also known as: Home monitoring
Gender education and home monitoring

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coitus

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative Techniques

Central Study Contacts

Selma Kahraman, Professor, Doctor

CONTACT

Zeliha Turan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 8, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

December 8, 2025

Record last verified: 2025-11