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NOT YET RECRUITING
NCT07736443
NA

Effective Implementation Control Trial

Sponsor: Universiti Putra Malaysia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

5 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2026-08-01

Completion Date

2027-05-31

Last Updated

2026-07-30

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

SmileConnect

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.

Locations (1)

Baqai Medical University

Karachi, Sindh, Pakistan