Clinical trial NCT04665219: HBM for Empowering Parental Toothbrushing and Sugar Intake Control
Official title: Health Belief Model for Empowering Parental Toothbrushing and Sugar Intake Control in Reducing Early Childhood Caries Among Young Children - a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Mobile Phone Use
Early Childhood Caries
Keywords: Health Belief Model
Mobile Health
Early Childhood Caries
Oral Health Promotion
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It has been recognized that oral health education for parents is critical for the prevention of early childhood caries (ECC). Few parents practiced caries prevention procedures for their children in daily life, though. Inspired by Health Belief Model (HBM) and using text messaging as a vehicle, a novel intervention scheme will be developed in this study. The objective of the present randomized clinical trial (RCT) is to investigate the effectiveness of the HBM-based behavioral intervention using text message to reduce early childhood caries of children at age 4 through promoting the parental oral health care behaviors (toothbrushing and sugar intake control) for their young children compared to conventional oral health education. This RCT will recruit child-parent dyads in 26-36 child help centers or kindergartens with nursery classes located in Hong Kong. A total of 518-628 dyads will be recruited and randomly allocated into the test or control group with a 1:1 ratio. For parents in the test group, the intervention will consist of a set of HBM-based text messages sent regularly in the following 48 weeks. A standard text message will be sent to the parents in the control group. The primary outcome will be dental caries measured by dmft/dmfs of the children at 4 years old.

By HBM-based intervention via a low-cost text messaging vehicle, it should be able to help the parents establish proper oral health behaviors for their children and safeguard the oral health of children in Hong Kong.


Eligibility criteria: Inclusion Criteria:

* young child aged18-30 months
* young children not having any severe medical conditions complicating oral health and dental examination
* parents having a mobile phone with certain Apps to receive the text messages in time (e.g. WhatsApp or WeChat)
* parents who can read Chinese

Exclusion Criteria:

* families that have been participating in another oral health promotion program

Primary outcomes:
measure: dmft/dmfs scores of the children at 4 years old
timeFrame: The children will be examined at the 24 months follow up. The tooth status of the erupted primary teeth would be assessed by careful visual inspection.
Secondary outcomes:
measure: average frequency of parental toothbrushing per day
timeFrame: 24 months
measure: average frequency of intake of sugary snack/drink per day
timeFrame: 24 months
measure: oral hygiene status using the Visible Plaque Index
timeFrame: 24 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The University of Hong Kong
Study officials:
References:
citation: Wang K, Lee GHM, Liu P, Gao X, Wong SYS, Wong MCM. Health belief model for empowering parental toothbrushing and sugar intake control in reducing early childhood caries among young children-study protocol for a cluster randomized controlled trial. Trials. 2022 Apr 12;23(1):298. doi: 10.1186/s13063-022-06208-w.