Effective Implementation Control Trial

NCT07736443 | Not Yet Recruiting DMC

• 1 other identifier: BMUUUUU
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children; Family Engagement; Oral Health Behavior Change

Keywords

Children; Parents; Family Engagement; Children's oral health, family engagement, parents, caregiver engagement, WhatsApp, digital health, mHealth, oral health promotion, oral hygiene,

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Secondary Outcomes (4)

• Parent-supervised twice-daily toothbrushing

  6 Months

• Child toothbrushing frequency

  6 Months

• Toothbrushing technique

  6 Months

• Dietary behaviours (sugary foods/drinks)

  6 Months

Other Outcomes (4)

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

  6 Months

• Fidelity

  6 Months

• Reach

  6 months

Study Arms (2)

Theory-Driven WhatsApp Family Engagement Intervention

EXPERIMENTAL

Parents receive a theory-driven digital oral health programme via WhatsApp, including educational messages, reminder prompts, short videos, interactive quizzes, parent-child brushing activities, and behavioural support in addition to routine oral health education.

Behavioral: SmileConnect

Usual Oral Health Education

NO INTERVENTION

Parents and children receive routine oral health education currently provided through schools or community health services, with no additional digital family engagement.

Interventions

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.

Theory-Driven WhatsApp Family Engagement Intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Baqai Medical University

Karachi, Sindh, 75340, Pakistan

Location

Central Study Contacts

Dr. Muhammad Arshed, MBBS, MPH, PhD

CONTACT

+923337474464; drarshedchaudhary@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Care Provider, Investigator and Outcomes Assessor are masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Schools will serve as the unit of randomization and will be randomly allocated in a 1:1 ratio to either the intervention or control arm using a computer-generated randomization sequence. Parents of children attending intervention schools will receive a theory-driven WhatsApp-based family engagement programme consisting of oral health education, behaviour-change messages, reminders, short videos, interactive activities, and parent-child toothbrushing challenges in addition to routine school oral health education. Parents of children in control schools will receive routine school oral health education only. Clinical and behavioural outcomes will be measured among participating children at baseline and follow-up by blinded, calibrated assessors. The trial will also evaluate implementation outcomes, including acceptability, adoption, feasibility, fidelity, reach, and sustainability, using a Hybrid Type 2 effectiveness-implementation design.

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)