Healthy WomenNCT07538219
The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.
A study testing Anticipatory Guidance Using Motivational Interviewing and Conventional Ministry of Health Anticipatory Guidance in people with Healthy Women and Caries of Infancy, run by Universiti Sains Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women, Caries of Infancy
- What is being tested?
- Anticipatory Guidance Using Motivational Interviewing and Conventional Ministry of Health Anticipatory Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 12 Apr 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers:
- Malaysian citizens
- Can read and understand Bahasa Malaysia
- Aged 18 years old and above
- Infants:
- Aged 6 months old (with or without erupted teeth)
- Born full-term (≥37 weeks of gestation)
- Without diagnosed congenital anomalies or syndromes
Who cannot join
- Mothers
- o Mothers experiencing postpartum depression or other significant postnatal issues
- Infants
- Diagnosed with special needs, chronic diseases, or developmental defects
- Infants who are at risk for oral health problems due to pre-existing medical conditions
- Infants requiring specialized oral healthcare, such as those with cleft lip and palate, enamel hypoplasia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries: A Cluster Randomised Controlled Trial Among Mothers of Infants in Terengganu.
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.
Read more
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 and dental officers/therapists 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.
Data will be analysed using descriptive statistics, paired t-tests, independent t-tests, McNemar's test, and Chi-Square test with significance set at p < 0.05.
Ethical approval was obtained from Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM)/ 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.
- Conditions
- Healthy Women, Caries of Infancy
- Being tested
- Anticipatory Guidance Using Motivational Interviewing, Conventional Ministry of Health Anticipatory Guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipatory Guidance Using Motivational InterviewingBehavioural
A collaborative, patient-centered communication approach that helps strengthen patients' motivation to change health behaviors
Conventional Ministry of Health Anticipatory GuidanceBehavioural
A process of providing practical developmentally appropriate health information about their children to parents so that they know what to expect during the child's current and approaching stage of development.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Anticipatory Guidance through Motivational Interviewing Receives: Behavioral: Anticipatory Guidance Using Motivational Interviewing |
| Control group | Experimental | Conventional Ministry of Health anticipatory guidance Receives: Behavioral: Conventional Ministry of Health Anticipatory Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' knowledge regarding infant oral health care
Questionnaire from Mukhtar et al., 2023
Measured: 6 months
Mother's practice regarding infant oral health care
Questionnaire from Mukhtar et al., 2023
Measured: 6 months
Secondary outcomes (2)
Incidence of ECC of infants
Incidence of early childhood caries on infants (using charts from Evans et al., 2017)
Measured: 6 months
Dental caries risk status of infants
Dental caries risk status of infants (using Caries Risk Assessment from Evans et al., 2017)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start12 Apr 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nor Aida Abdul Malik, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538219
- Sponsor's protocol ID
- USM/JEPeM/KK/25080733
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries: A Cluster Randomised Controlled Trial Among Mothers of Infants in Terengganu.
- ClinicalTrials.gov ID
- NCT07538219
- Acronym / sponsor ID
- USM/JEPeM/KK/25080733
- Conditions
- Healthy Women, Caries of Infancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 12 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 and dental officers/therapists 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.
Data will be analysed using descriptive statistics, paired t-tests, independent t-tests, McNemar's test, and Chi-Square test with significance set at p < 0.05.
Ethical approval was obtained from Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM)/ 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: Anticipatory Guidance Using Motivational InterviewingAnticipatory Guidance through Motivational Interviewing |
| Control group | Experimental | Behavioral: Conventional Ministry of Health Anticipatory GuidanceConventional Ministry of Health anticipatory guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mothers:
- Infants:
Key exclusion criteria (6 listed)
- Mothers
- o Mothers experiencing postpartum depression or other significant postnatal issues
- Infants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticipatory Guidance Using Motivational InterviewingA collaborative, patient-centered communication approach that helps strengthen patients' motivation to change health behaviors | Behavioural | Study group |
| Conventional Ministry of Health Anticipatory GuidanceA process of providing practical developmentally appropriate health information about their children to parents so that they know what to expect during the child's current and approaching stage of development. | Behavioural | Control group |
Primary outcome
Mothers' knowledge regarding infant oral health care
Time frame: 6 months
Questionnaire from Mukhtar et al., 2023
Mother's practice regarding infant oral health care
Time frame: 6 months
Questionnaire from Mukhtar et al., 2023
2 secondary outcomes
Incidence of ECC of infants
Time frame: 6 months
Dental caries risk status of infants
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipatory Guidance Using Motivational Interviewing and Conventional Ministry of Health Anticipatory Guidance in people with Healthy Women and Caries of Infancy, run by Universiti Sains Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABDUL MALIK NOR AIDA, DOCTOR OF DENTAL SURGERY (+60139127520, aidafgg05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mothers' knowledge regarding infant oral health care (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.