[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"caries-of-infancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:caries-of-infancy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100634325","the-effectiveness-of-motivational-interviewing-in-preventing-early-childhood-caries-among-mothers-of-infants-in-terengganu-100634325",false,"NCT07538219","The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.","The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries: A Cluster Randomised Controlled Trial Among Mothers of Infants in Terengganu.","Inclusion Criteria:\n\n* Mothers:\n\n  * Malaysian citizens\n  * Can read and understand Bahasa Malaysia\n  * Aged 18 years old and above\n* Infants:\n\n  * Aged 6 months old (with or without erupted teeth)\n  * Born full-term (≥37 weeks of gestation)\n  * Without diagnosed congenital anomalies or syndromes\n\nExclusion Criteria:\n\n* Mothers\n\n  o Mothers experiencing postpartum depression or other significant postnatal issues\n* Infants\n\n  * Diagnosed with special needs, chronic diseases, or developmental defects\n  * Infants who are at risk for oral health problems due to pre-existing medical conditions\n  * Infants requiring specialized oral healthcare, such as those with cleft lip and palate, enamel hypoplasia",true,"FEMALE","18 Years",{"count":20,"type":21},228,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study will be conducted in Ministry of Health (MOH) Maternal and Child Health Clinics (MCHCs) and MOH dental clinics in Setiu and Hulu Terengganu, selected for their similar sociodemographic characteristics. A two-arm, parallel cluster-randomized controlled trial (1:1 allocation) will be implemented, where the study group receives Anticipatory Guidance (AG) through Motivational Interviewing (MI), and the control group receives conventional MOH AG.\n\nMothers aged ≥18 years who can understand Bahasa Malaysia and their healthy 6-month-old infants (full-term, without congenital conditions) are eligible. Mothers with postpartum depression and infants requiring special oral healthcare are excluded. A total of 228 mother-infant pairs will be recruited using multistage sampling. Three MCHCs from Setiu and three randomly selected MCHCs from Hulu Terengganu will participate. Systematic sampling will be applied within each clinic.\n\nData collection occurs at infant ages 6, 9, and 12 months during routine immunization visits. At each visit, infants undergo oral examination using ICDAS and a caries risk assessment. Mothers complete age-specific validated questionnaires on knowledge and practices. The study group receives two MI sessions (at 6 and 9 months) with follow-up phone calls, while the control group receives routine AG by MOH staff.\n\nThe MI protocol will be developed based on established MI frameworks and be validated through expert review, will be pretested among mothers and dental officers\u002Ftherapists in MOH MCHC and MOH dental clinic in Besut district. While fidelity assessment of MI sessions conducted will be done using MITI 4.2.1 guidelines. All MI sessions will be delivered by the trained principal investigator. Approximately 8 minutes are required for infant oral examination, 7 minutes for questionnaire completion, and 30 minutes for MI.\n\nData will be analysed using descriptive statistics, paired t-tests, independent t-tests, McNemar's test, and Chi-Square test with significance set at p \\\u003C 0.05.\n\nEthical approval was obtained from Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM)\u002F Human Research Ethics Committee USM (HREC) and Medical Research and Ethics Committee (MREC) MOH. Participation is voluntary, with confidentiality ensured. No major risks are expected.",[27,28],"Healthy Women","Caries of Infancy","NOT_YET_RECRUITING","2026-04-12",{"date":32,"type":33},"2026-04-20","ACTUAL",{"date":30,"type":21},{"date":36,"type":21},"2026-11-30",{"name":38,"class":39},"Universiti Sains Malaysia","OTHER"]