[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551555":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","PLACEBO_COMPARATOR","Patients in the control group will receive traditional health education, which consist of routine oral health education and oral health instructions during their visits for orthodontic treatment.",[13],"Behavioral: Traditional Health Education",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention Group","EXPERIMENTAL","Patients in the intervention group will receive a health diary to plan and clock for their fixed orthodontic self-management behaviors in addition to the traditional health education.",[19],"Behavioral: Health Diary Program",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Health Diary Program","The health diary is constructed based on the theory of health action process approach, which is used to plan and clock for self-management behaviors of adolescent patients during fixed orthodontic treatment.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Traditional Health Education","Traditional health education is that the nurse orally teaches the patient about fixed orthodontic knowledge, and the patient obtains a paper information.",[9],[32],{"name":33,"affiliation":5,"role":34},"Wei Xia, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+8618823359471","xiaw23@mail.sysu.edu.cn",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Jie Chen, Master","+8613640838051","chenjttxs@163.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Guangzhou","Guangdong","510080","China","CN",{"type":53,"coordinates":54},"Point",[55,56],113.25,23.11667,{"lat":56,"lon":55},[59,60],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":61,"phoneExt":26,"email":43},"13640838051",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Wei XIA, PhD","Association Professor","100551555","effect-of-health-diary-on-self-management-in-adolescent-patients-with-fixed-orthodontic-appliance-100551555",false,"NCT06461611","Effect of Health Diary on Self-management in Adolescent Patients With Fixed Orthodontic Appliance","Effect of Health Diary on Self-management in Adolescent Patients With Orthodontic Fixed Appliance: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with malocclusion eligible for fixed appliance orthodontic treatment;\n* The age of patients ranged from 12 to 18 years;\n* The patients received orthodontic treatment for the first time;\n* The patient was alert and had no cognitive or psychiatric impairment;\n* The patient was able to read and fill out the questionnaires, and had good listening, speaking and understanding skills in Chinese.\n\nExclusion Criteria:\n\n* The patient's disease was diagnosed as jaw deformity associated with other diseases. Malocclusion secondary to trauma, tumor, cleft lip and palate;\n* Patients treated with orthodontic-orthognathic surgery;\n* The patient currently participating in other oral related intervention studies.","ALL","12 Years","18 Years",{"count":77,"type":78},140,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study aims to use two-arm randomized clinical trials to evaluate the effectiveness of the health diary in helping adolescents wearing fixed orthodontic appliances improve their oral hygiene status, self-management skills, oral health-related quality of life, self-efficacy, intention，number of breakages, and on-time and return visit status.",[84,85],"Oral Hygiene","Self-Management",[87,88,89,85,90,91,92,84],"Malocclusion","Fixed Orthodontic Treatment","Adolescent","Self-Efficacy","Health Diary","Oral Health-Related Quality of Life","2024-07-24",{"date":95,"type":96},"2024-07-25","ACTUAL",{"date":98,"type":96},"2024-06-01",{"date":100,"type":78},"2025-07-31",{"name":64,"class":6},1]