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Motivational Interviewing Prevents Early Childhood Caries, 228 Mother-Infant Pairs, Malaysia

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Summary

NIH ClinicalTrials.gov registered a two-arm parallel cluster-randomized controlled trial (NCT07538219) in Malaysia comparing Motivational Interviewing-based Anticipatory Guidance versus conventional Ministry of Health Anticipatory Guidance for preventing early childhood caries. The study will recruit 228 mother-infant pairs from MOH Maternal and Child Health Clinics in Setiu and Hulu Terengganu, with data collection at infant ages 6, 9, and 12 months.

“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”

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What changed

NIH registered a new clinical trial (NCT07538219) on ClinicalTrials.gov describing a parallel cluster-randomized controlled trial comparing Motivational Interviewing-based Anticipatory Guidance against conventional Ministry of Health Anticipatory Guidance for early childhood caries prevention among 228 mother-infant pairs in Terengganu, Malaysia. The trial includes oral examinations using ICDAS at 6, 9, and 12 months and validated maternal questionnaires.

For maternal and child health clinics, dental professionals, and researchers in oral health intervention, this registry entry documents a structured comparison between behavioral coaching techniques (MI) and standard health guidance for preventing infant caries. No compliance obligations arise from this study registration.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.

N/A NCT07538219 Kind: NA Apr 20, 2026

Abstract

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.

Mothers 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.

Data 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.

The MI protocol will be developed based on established MI frameworks and be validated through expert review, will be pretested among mothers an...

Conditions: Healthy Women, Caries of Infancy

Interventions: Anticipatory Guidance Using Motivational Interviewing, Conventional Ministry of Health Anticipatory Guidance

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Oral health intervention Clinical trial participation Caries prevention
Geographic scope
MY MY

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Public Health Healthcare

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