Effective Implementation Control Trial

ConditionsChildren Family Engagement Oral Health Behavior Change

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age5-12

SponsorUniversiti Putra Malaysia

About this trial

This study will evaluate the effectiveness and implementation of a theory-driven, WhatsApp-based family engagement intervention designed to improve oral health among primary school children. Parents or primary caregivers will be randomly assigned (individually or by school, depending on the study design) to either receive the digital intervention or usual care. The intervention will deliver structured oral health education, behaviour-change messages, reminder prompts, short videos, interactive quizzes, and parent-child brushing activities through WhatsApp over a predefined intervention period (e.g., 6-12 months).

The primary effectiveness outcomes will include improvements in children's oral hygiene status (e.g., OHI-S, Plaque Index, Gingival Index, and dental caries where appropriate) and oral health behaviours such as twice-daily toothbrushing and reduced sugary snack consumption. Secondary outcomes may include parental oral health literacy, self-efficacy, and supervised brushing practices.

Alongside effectiveness, the study will assess implementation outcomes-including acceptability, feasibility, adoption, fidelity, reach, and sustainability-to determine whether the intervention can be successfully integrated into routine school and community oral health programmes. Findings will provide evidence on both whether the intervention works and how it can be implemented and scaled in low- and middle-income countries.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Parent or primary caregiver of a child enrolled in a participating primary school.

Child aged 5-12 years (or the age range specified by the study).

Parent or caregiver owns or has regular access to a smartphone with an active WhatsApp account.

Parent or caregiver is able to read and understand the study language(s) (e.g., Urdu and/or English).

Disqualifiers

Parent or caregiver declines or withdraws informed consent.

Child has a medical, developmental, or cognitive condition that would prevent participation in routine oral health assessments or toothbrushing activities, as determined by the investigators.

Child is currently participating in another oral health intervention or clinical trial that could influence the study outcomes.

Parent or caregiver plans to relocate or anticipates being unavailable during the study follow-up period.

Trial design

Design model

Parallel

Treatments tested in this trial

SmileConnect
Behavioral
SmileConnect is a theory-driven, WhatsApp-based family engagement programme designed to improve children's oral health by supporting parents with structured educational content, behaviour-change messages, reminder prompts, short videos, interactive quizzes, parent-child toothbrushing activities, motivational feedback, and reinforcement strategies. The intervention is grounded in behavioural science and aims to promote sustainable oral hygiene practices while facilitating scalable implementation within school and community settings.

Treatment groups

1,200 Participants

are divided into 2 treatment groups

Group A: Theory-Driven WhatsApp Family Engagement InterventionExperimental treatment 1 intervention

Group B: Usual Oral Health EducationNo intervention 0 interventions

Trial outcomes

Primary outcomes

Children's oral hygiene status

Children's oral hygiene status will be measured by Oral Hygiene Index-Simplified (OHI-S). Six index teeth examined. Debris Index (0-3) + Calculus Index (0-3); total score 0-6. Lower scores indicate better oral hygiene. Excellent: 0-1.2; Fair: 1.3-3.0; Poor: 3.1-6.0.

Time frame

6 Months

Secondary outcomes

Parent-supervised twice-daily toothbrushing

Number of days/week supervised (0-7) or Yes/No for morning and bedtime brushing. Higher scores indicate better supervision.

Time frame

6 Months

Child toothbrushing frequency

Times brushed/day (0-3+). Categorized as \<2/day or ≥2/day.

Time frame

6 Months

Toothbrushing technique

Checklist (e.g., 10-12 steps). Score 0-10 or 0-12. Higher scores indicate better brushing technique.

Time frame

6 Months

Dietary behaviours (sugary foods/drinks)

Frequency/week or/day. Lower frequency indicates healthier dietary behaviour.

Time frame

6 Months

Other outcomes

Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM)

The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) are measured by validated 4-item psychometric survey scales using a 5-point Likert scale ranging from 1 ("completely disagree") to 5 ("completely agree"), with a total score of 4-20 or a mean score. Higher scores indicate greater acceptability. There are no official cut-off scores or universal norms yet.

Time frame

6 Months

Fidelity

Percentage (%) of intervention components delivered as planned. Higher percentages indicate better fidelity.

Time frame

6 Months

Reach

Reach will be assessed as the proportion of eligible parents who enroll in and are exposed to the digital family engagement intervention. Measures will include: (1) participation rate, calculated as the number of parents enrolled divided by the number of eligible parents approached, multiplied by 100; (2) intervention exposure rate, calculated as the proportion of enrolled parents who successfully receive at least one WhatsApp intervention message; and (3) retention rate, calculated as the proportion of enrolled parents who remain contactable and continue participation at 6 months. Higher percentages indicate greater reach.

Time frame

6 months

Digital Engagement

Measured using indicators such as messages delivered, messages read, videos opened/viewed, quizzes completed, reactions or replies, and completion of weekly activities. Indicators may be reported separately and combined into a prespecified engagement score. Higher values indicate greater engagement.

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Putra Malaysia

Lead sponsor

Source ClinicalTrials.gov

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