Health Belief Model and Family-based Mobile-health Intervention to Promote Oral Health in Adolescents: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Caries increment
研究概览
简要总结
The aim of this study is to investigate the effectiveness of the family and behavioral theory based mobile-health behavioral intervention in enhancing adolescents'good oral health behaviors (mainly oral hygiene practice and free sugar intake control) and preventing common oral diseases (dental caries and periodontal diseases).
详细描述
The investigators propose a 30-months clustered randomized controlled trial to investigate the effectiveness of Health Belief Model (HBM) and family-based mobile-health intervention in enhancing the adolescents' good oral health behaviors and preventing oral diseases.
This is a three-arm parallel-design cluster-randomized controlled trial. Parents and their children (12 to 15-year-old) will be recruited and randomized into 3 groups based on the school sites.
Messages targeted on six domains guided by HBM will be sent to the adolescents and their parents via mobile phone. Two blocks of HBM-based oral health messages, reminders, feedback and reinforcement messages will be delivered to both students and parents by mobile phone for 24 weeks; while the intervention of the other 2 groups will target on students only or using prevailing oral health education.
The primary outcomes will be caries increment of the adolescents 2-year post-intervention. Change in oral health self-efficacy and behaviors, dental plaque and gingival bleeding index will be the secondary outcomes.
The investigators anticipate the proposed family- and HBM-based behavioral intervention is more effective than HBM-based mobile-health intervention on adolescents alone or prevailing oral health education in improving the adolescents' oral hygiene behaviors, reducing free-sugar intake and preventing oral diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese ethnicity;
- •Student living with their own parent(s) or primary caregivers;
- •Both student and parent(s) or primary caregiver having their own access to a personal mobile phone with certain Apps to receive the messages in time
排除标准
- •Student currently on a special diet (e.g. severe inflammatory bowel disease);
- •Student has medical conditions know to affect growth or eating (e.g. diabetes, cystic fibrosis);
- •Enrollment in other oral health promotion programs or research studies.
结局指标
主要结局
Caries increment
时间窗: 2 years
Dental caries increment (by tooth level) from baseline to 2 years follow up
次要结局
- Change of oral health self-efficacy(2 years)
- Change of gingival status(2 years)
- Change of free-sugar intake(2 years)
- Change of toothbrushing behavior(2 years)
研究者
Dr Liu, Pei Pearl
Principal Investigator
The University of Hong Kong