Clinical Trials Directory

Trials / Completed

CompletedNCT04562675

Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries

Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
Sex
Female
Age
22 Years – 48 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLHA interventionFor the IG, a 4-hour lesson consisting of 4 chapters and leaflets was delivered over 4 weeks, with one chapter per hour per week. Each LHA visited the assigned mother in the IG four times in a 4-week period.
OTHERbrochure-onlybrochure-only for control group (CG)

Timeline

Start date
2012-08-27
Primary completion
2015-10-31
Completion
2015-10-31
First posted
2020-09-24
Last updated
2020-09-24

Source: ClinicalTrials.gov record NCT04562675. Inclusion in this directory is not an endorsement.