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NCT Number: NCT07736443

Effective Implementation Control 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.

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Key information

Conditions

Children Family Engagement Oral Health Behavior Change

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • Parent or caregiver is willing to receive WhatsApp messages throughout the intervention period.
  • Parent or caregiver provides written informed consent; child provides assent where age-appropriate.

Exclusion criteria

  • 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.
  • Child requires urgent medical or dental care that would preclude participation, as judged by the study dentist (children identified with urgent dental needs during screening will be referred for appropriate care and their eligibility will be determined by the study protocol).
  • More than one eligible child from the same household is enrolled; in such cases, one child will be selected according to the study protocol to maintain independence of observations.

Treatment and study plan

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.

Primary outcomes

  1. Children's oral hygiene status

    Time frame: 6 Months

    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.

Secondary outcomes

  1. Parent-supervised twice-daily toothbrushing

    Time frame: 6 Months

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

  2. Child toothbrushing frequency

    Time frame: 6 Months

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

  3. Toothbrushing technique

    Time frame: 6 Months

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

  4. Dietary behaviours (sugary foods/drinks)

    Time frame: 6 Months

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

Other outcomes

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

    Time frame: 6 Months

    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.

  2. Fidelity

    Time frame: 6 Months

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

  3. Reach

    Time frame: 6 months

    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.

  4. Digital Engagement

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Muhammad Arshed, MBBS, MPH, PhD

CONTACT

[email protected]

+923337474464

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

A Theory-Driven Digital Family Engagement Intervention to Improve Children's Oral Health: A Hybrid Effectiveness-Implementation Cluster Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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