Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:52 AM
Study NCT ID:
NCT07460661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gamified Healthy Lifestyle Training in Women Undergoing Assisted Reproductive Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthy Lifestyle Behaviors', 'timeFrame': 'At baseline and at 4 and 12 weeks', 'description': 'Change in healthy lifestyle behaviors measured using the Healthy Lifestyle Behaviors Scale II (HLBS-II). The scale assesses health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. Higher scores indicate better healthy lifestyle behaviors.The scale has no cut-off value. Total scores range from 52 to 208, with higher scores indicating better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Infertility Self-Efficacy', 'timeFrame': 'At baseline and at 4 and 12 weeks', 'description': 'Change in infertility self-efficacy measured using the Infertility Self-Efficacy Scale Short Form. Total scores range from 8 to 32; higher scores indicate greater perceived ability to cope with infertility-related challenges and treatment processes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Assisted Reproductive Treatment, Infertility, Healthy Lifestyle, Gamification, Self-Efficacy'], 'conditions': ['Infertility in Women Undergoing Assisted Reproductive Treatment', 'Infertility', 'Assisted Reproductive Technology', 'Health Lifestyle Behaviors', 'Self-Efficacy']}, 'descriptionModule': {'briefSummary': 'Objective: A prospective randomized controlled trial with a pretest-posttest design was planned to evaluate the effects of a gamified healthy lifestyle behaviors training intervention using the D6 model, to be administered to women undergoing assisted reproductive treatment (ART), on healthy lifestyle behaviors and infertility self-efficacy.\n\nAim: Reproductive health and Assisted Reproductive Technologies (ART) have undergone rapid technological and clinical development in recent years, offering a variety of treatment options to couples struggling with infertility. Methods such as Intrauterine Insemination (IUI), In Vitro Fertilization (IVF), and Intracytoplasmic Sperm Injection (ICSI) are the most common practices aimed at increasing pregnancy rates. However, these treatments are complex processes affected by high stress levels, emotional burden, and lifestyle factors. Strengthening individuals\' sense of self-efficacy strengthens their motivation to adapt to treatment and achieve health-related goals. In this intense and complex treatment process, it is essential to strengthen the self-efficacy perceptions of infertile couples, as this can enhance their motivation to achieve health-related goals by improving their adaptation to the treatment process. Although the literature reveals findings indicating that the development of healthy lifestyle behaviors positively influences the treatment outcomes of individuals undergoing infertility treatment, it is an undeniable fact that developing and sustaining such behaviors is often challenging-even for healthy individuals. For those experiencing infertility, which represents a complex life crisis both psychologically and physiologically, this process can become even more difficult. In this context, gamification is intended to be utilized as an innovative approach by integrating it into the process of promoting healthy lifestyle behaviors among infertile women.\n\nMethod: This study will be a prospective randomized controlled trial with a pretest-posttest model. The study population will consist of women undergoing assisted reproductive treatment who presented to the In Vitro Fertilization Unit in the Infertility and Reproductive Endocrinology Department at Istanbul University, Istanbul Faculty of Medicine Service Building, between October 2025 and October 2026. The sample will consist of 105 infertile women who met the study criteria based on a power analysis and agreed to participate in the study. After obtaining informed consent from infertile women who meet the study criteria and agree to participate, the women will be randomly assigned to three groups based on age, type of ART (IUI, IVF, ICSI), and number of treatments to ensure equality between the groups. These groups will be divided into three groups: a group receiving gamified healthy lifestyle behaviors education and a booklet during the ART process, a group receiving only the booklet, and a group receiving standard ART clinic training. All study groups will complete an Introductory Information Form, the Healthy Lifestyle Behavior Follow-up Form for Infertile Women, the Healthy Lifestyle Behavior Scale II (HLBS II), and the Infertility Self-Efficacy Scale Short Form (SES). One group will receive the gamified healthy lifestyle behaviors education program and a booklet, while the second group will receive the healthy lifestyle behaviors education booklet. The third group will receive standard ART clinic training. Post-tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form) and "Gamified Healthy Lifestyle Behaviors Training Program Evaluation Form" was given to the group receiving gamified healthy lifestyle behaviors training will be administered to all groups at the end of Month 1. Repeat tests (Healthy Lifestyle Behaviors for Infertile Women Follow-up Form, Healthy Lifestyle Behaviors Scale II, Infertility Self-Efficacy Scale Short Form, and Gamified Healthy Lifestyle Behaviors Education Program Evaluation Form) will be administered at Month 3.\n\nAs part of the study, the effects of gamified healthy lifestyle behaviors and self-efficacy on the healthy lifestyle behaviors and self-efficacy of infertile women who received gamified healthy lifestyle behaviors education and an educational booklet during the ART process will be compared with those of infertile women who received only the educational booklet, compared to those who received standard ART clinic training. This will scientifically demonstrate the contribution of the gamification approach to the behavioral change processes of infertile women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female who undergoing assisted reproductive treatment are eligible to participate in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-49 years\n* Diagnosed with primary infertility\n* Currently undergoing assisted reproductive treatment (IUI, IVF, or ICSI)\n* Able to read, understand, and communicate in Turkish\n* Have access to a digital device (mobile phone, tablet, or computer) and internet connection\n* Provide voluntary written informed consent\n\nExclusion Criteria:\n\n* Diagnosed psychiatric disorder that may interfere with participation\n* Presence of a severe medical condition (e.g., active cancer or other serious systemic disease) that may affect treatment outcomes\n* Medical complications requiring hospitalization during the study period\n* Communication barriers preventing completion of study procedures\n* Withdrawal of consent at any time during the study'}, 'identificationModule': {'nctId': 'NCT07460661', 'briefTitle': 'Gamified Healthy Lifestyle Training in Women Undergoing Assisted Reproductive Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'The Effect of Gamified Healthy Lifestyle Behavior Training on Healthy Lifestyle and Self-Efficacy in Women Undergoing Assisted Reproductive Treatment', 'orgStudyIdInfo': {'id': 'Doktora1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gamified Healthy Lifestyle Education + Digital Healthy Lifestyle Education Booklet', 'description': 'Gamified Healthy Lifestyle Education:\n\nA structured gamified healthy lifestyle behaviors education program based on the D6 gamification model. The intervention includes digital interactive modules covering nutrition, physical activity, stress management, health responsibility, and social support, delivered via an online platform during the assisted reproductive treatment process.', 'interventionNames': ['Behavioral: Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet']}, {'type': 'EXPERIMENTAL', 'label': 'Digital Healthy Lifestyle Education Booklet', 'description': 'A digital healthy lifestyle education booklet developed based on current evidence, including information on nutrition, physical activity, stress management for women undergoing assisted reproductive treatment.', 'interventionNames': ['Behavioral: Digital Healthy Lifestyle Education Booklet']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No Intervention Standard ART Clinic Education'}], 'interventions': [{'name': 'Gamified Healthy Lifestyle Education+Digital Healthy Lifestyle Education Booklet', 'type': 'BEHAVIORAL', 'description': 'A structured, theory-based gamified healthy lifestyle education program developed in accordance with the D6 gamification model. The program is delivered via a digital platform and includes modules focusing on nutrition, physical activity, stress management, and social support. Gamification elements such as points, badges integrated to enhance motivation and participant engagement. In addition to gamified healthy lifestyle behavior training, a digital training booklet is also provided. The intervention is implemented alongside routine clinical care.', 'armGroupLabels': ['Gamified Healthy Lifestyle Education + Digital Healthy Lifestyle Education Booklet']}, {'name': 'Digital Healthy Lifestyle Education Booklet', 'type': 'BEHAVIORAL', 'description': 'An evidence-based, digitally delivered healthy lifestyle education booklet. The booklet contains structured information on nutrition, physical activity, stress management, health responsibility, and social support for women undergoing assisted reproductive treatment. Participants receive this booklet in addition to their routine clinical training.', 'armGroupLabels': ['Digital Healthy Lifestyle Education Booklet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'state': 'Uskudar', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Belgin Devranoglu, PhD', 'role': 'CONTACT', 'email': 'belgin.devranoglu@sbu.edu.tr', 'phone': '+902163910680'}], 'facility': 'Istanbul Provincial Health Directorate Zeynep Kamil Women and Children Diseases Traning and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Duygu DOKUMACI, MSc, PhD Candidate', 'role': 'CONTACT', 'email': 'duygu.dokumaci@gmail.com', 'phone': '+905076503518'}, {'name': 'Dilek COSKUNER POTUR, PhD', 'role': 'CONTACT', 'email': 'dilekcp@yahoo.com'}], 'overallOfficials': [{'name': 'Dilek COSKUNER POTUR, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marmara University'}, {'name': 'DUYGU DOKUMACI, MSc, PhD Candidate', 'role': 'STUDY_CHAIR', 'affiliation': 'Marmara University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dilek Potur', 'investigatorAffiliation': 'Marmara University'}}}}