A Theory-Driven Digital Family Engagement Intervention to Improve Children's Oral Health: A Hybrid Effectiveness-Implementation Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Children's oral hygiene status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Care Provider, Investigator and Outcomes Assessor are masked.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Children's oral hygiene status
时间窗: 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.
次要结局
- Parent-supervised twice-daily toothbrushing(6 Months)
- Child toothbrushing frequency(6 Months)
- Toothbrushing technique(6 Months)
- Dietary behaviours (sugary foods/drinks)(6 Months)
研究者
Arshed Muhammad
PhD
Universiti Putra Malaysia