Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT07211893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of MyopiaEd Messaging on Improving Eye-use Behavior and Myopia Control Among Primary School Students in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1330}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of children having improved eye-use behaviors after 1 year.', 'timeFrame': '12 months', 'description': 'Children are considered to have improved behaviors if they meet three or more of the following criteria after 12 months:\n\nOutdoor Time: Increase of ≥ 30 minutes for those initially \\< 2 hours; maintain ≥ 2 hours for those initially ≥ 2 hours.\n\nNear Work Time: Reduce ≥ 30 minutes for those initially ≥ 1 hour; maintain \\< 1 hour for those initially \\< 1 hour.\n\nScreen Time: Reduce ≥ 30 minutes for those initially ≥ 1 hour; maintain \\< 1 hour for those initially \\< 1 hour.\n\nEye Exam Frequency: Increase of ≥ 1 exam for those with \\< 2 exams initially; maintain ≥ 2 for those with ≥ 2 exams.\n\nSitting Posture: Increase of ≥ 1 point for those with ≤ 3; maintain ≥ 4 for those with ≥ 4.\n\nResting Behavior During Near Work: Increase of ≥ 1 point for those with ≤ 3; maintain ≥ 4 for those with ≥ 4.\n\nSpectacle-Wearing: Children not wearing glasses begin after 12 months. Daily Spectacle Wear for Myopic Children: Increase of ≥ 1 hour for those wearing ≤ 8 hours; maintain \\> 8 hours for those wearing \\> 8 hour.'}], 'secondaryOutcomes': [{'measure': "Change in myopia-related knowledge score of students' guardians between baseline and 12 months", 'timeFrame': '12 months', 'description': "Change in myopia-related knowledge score of students' guardians between baseline and 12 months, assessed via questionnaire. The score ranged from 1 to 20, with higher scores indicating better knowledge."}, {'measure': 'Difference in incidence of myopia between the two groups after 12 months', 'timeFrame': '12 months', 'description': 'Difference in incidence of myopia between the two groups after 12 months'}, {'measure': 'Difference in the change of spherical equivalence between baseline and 12 months in the two groups', 'timeFrame': '12 months', 'description': 'Difference in the change of spherical equivalence between baseline and 12 months in the two groups. Spherical equivalence is calculated as sphere plus half of cylindrical power, as assessed by auto-refraction.'}, {'measure': 'The satisfaction of the MyopiaEd information by the guardians', 'timeFrame': '12 months', 'description': 'The satisfaction of the MyopiaEd information by the guardians, assessed by a study questionnaire. Satisfaction score ranges from 1 to 5, with higher scores indicating better satisfaction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Myopia represents a significant global public health challenge, with China experiencing particularly high myopia prevalence among children and adolescents. The World Health Organization (WHO) acknowledges the critical role of health education in eye care and has collaborated with the International Telecommunication Union (ITU) to launch the Be He@lthy, Be Mobile (BHBM) initiative, which includes MyopiaEd-a mobile health project specifically designed to address myopia. Developed in partnership with international experts and informed by evidence-based guidelines, MyopiaEd provides standardized, scientifically validated content for effective myopia control. The MyopiaEd library has been translated and adapted by the Zhongshan Ophthalmic Center for use in China. Therefore, we aim to investigate whether the Chinese version of MyopiaEd can improve eye care behaviors among primary school students and enhance parental knowledge regarding myopia prevention and control in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary school students in the third grade;\n* the guardians of students can receive, read, and understand multimedia (image-text) messages via WeChat on their mobile phones;\n* voluntary participation in this study, with guardians' consent and a signed informed consent form.\n\nExclusion Criteria:\n\n* with other ocular diseases that severely affect vision\n* with systematic diseases or mental disorders, inability to understand or cooperate with the study"}, 'identificationModule': {'nctId': 'NCT07211893', 'briefTitle': 'Effect of MyopiaEd Messaging on Improving Eye-use Behavior and Myopia Control Among Primary School Students in China', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'Effect of MyopiaEd Messaging on Improving Eye-use Behavior and Myopia Control Among Primary School Students in China: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2025KYPJ113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MyopiaEd Messaging', 'description': 'send myopia-related health education message from the MyopiaEd information repository', 'interventionNames': ['Other: Send myopia-related health education message']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no myopia-related health education message from the MyopiaEd information repository'}], 'interventions': [{'name': 'Send myopia-related health education message', 'type': 'OTHER', 'description': 'Guardians of students in the intervention group will receive regular myopia-related health education messages, comprising text and images, from the MyopiaEd information repository via class-based WeChat groups. The intervention will last for 12 months.', 'armGroupLabels': ['MyopiaEd Messaging']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lingyi Liang', 'role': 'CONTACT', 'email': 'lianglingyi@gzzoc.com', 'phone': '+8602087330487'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': "National Health Commission of the People's Republic of China", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}