Clinical trial NCT04562675: Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries
Official title: Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries,Dental
Keywords: Caries
immigrant
Lay health advisor
preventive behavior
oral hygiene
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 55
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the long-term effectiveness of a lay health advisor (LHA) intervention on immigrant children's caries and preventive behaviors.This randomized controlled trial included mother-child pairs in the intervention group (IG) and a brochure-only control group (CG), respectively. The IG received a four-week one-on-one session by an LHA on caries-related knowledge and brushing techniques. Baseline and follow-up surveys were used to collect the data in caries experience and maternal caries preventive behavior.

Detailed description: A randomized experimental design was used. Vietnamese women whose children aged 2-6 years were recruited through churches, Chinese schools, immigrant service centers, kindergarten, or recommendations from LHAs in Kaohsiung City in Taiwan. Overall, 30 and 25 Vietnamese mother-child pairs were randomized into the IG and CG. G\*Power (version 3.1.9.4) was used for power analysis. A power analysis was established by effect size as the mean difference of filled teeth change between baseline and 8-month follow-up measurement between the IG and CG, with sample size and 0.05 alpha level. The power was greater than 0.802, and research results have adequate power.All children underwent oral examination at baseline and at 1-week, 2- and 8-month follow-ups. Each child was examined by a dentist in accordance with the primary dentition caries experience.Each immigrant mother completed surveys at baseline and at 1-week and 8-month follow-ups.

Eligibility criteria: Inclusion Criteria:

* Vietnamese women whose children aged 2-6 years

Exclusion Criteria:

* None

Primary outcomes:
measure: dmft index
timeFrame: Change from Baseline dmft at 1 weeks after intervention
measure: dmft index
timeFrame: Change from Baseline dmft at 2 months after intervention
measure: dmft index
timeFrame: Change from Baseline dmft at 8 months after intervention
Secondary outcomes:
measure: Maternal preventive behavior
timeFrame: Change from Baseline at 1 weeks after intervention
measure: Maternal preventive behavior
timeFrame: Change from Baseline at 8 months after intervention
measure: Maternal caries-related knowledge
timeFrame: Change from Baseline at 1 weeks after intervention
measure: Maternal caries-related knowledge
timeFrame: Change from Baseline at 8 months after intervention
measure: Maternal attitude toward oral hygiene
timeFrame: Change from Baseline at 1 weeks after intervention
measure: Maternal attitude toward oral hygiene
timeFrame: Change from Baseline at 8 months after intervention
measure: Maternal self-efficacy toward oral hygiene
timeFrame: Change from Baseline at 1 weeks after intervention
measure: Maternal self-efficacy toward oral hygiene
timeFrame: Change from Baseline at 8 months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Kaohsiung Medical University
name: Hsiao-Ling Huang
role: PRINCIPAL_INVESTIGATOR
References: