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

September 23, 2020 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Vietnamese women whose children aged 2-6 years

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group (IG)
LHA intervention group (IG)
Behavioral: LHA intervention
For 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.
Placebo Comparator: Control group (CG)
brochure-only control group (CG)
Other: brochure-only
brochure-only for control group (CG)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
dmft index
Time Frame: Change from Baseline dmft at 1 weeks after intervention
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
Change from Baseline dmft at 1 weeks after intervention
dmft index
Time Frame: Change from Baseline dmft at 2 months after intervention
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
Change from Baseline dmft at 2 months after intervention
dmft index
Time Frame: Change from Baseline dmft at 8 months after intervention
The caries status of each tooth was recorded using the dmft index, as follows: decayed (d), missing (m), or filled (f) tooth (t). For each child, caries experience was measured using the dmft index of primary teeth.
Change from Baseline dmft at 8 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal preventive behavior
Time Frame: Change from Baseline at 1 weeks after intervention
Item including that"Do you ask your child to brush his/her teeth?" The response was coded as zero (not/seldom/sometimes) or one (always). "How many times you help your child to brush his/her teeth every day?" The response was coded as zero (no/less than two times/day) or one (two or more times/day). "How long do you help your child brush his/her teeth every time?" The response was coded as zero (no/less than three minutes) or one (three or more minutes). "When was the last time that you took your child for a dental visit?" and "Why did you take your child for a dental visit?" The responses were coded as zero (last dental visit more than six months or dental visit for oral or tooth discomfort) or one (last dental visit six months or less and dental visit for regular checkup).
Change from Baseline at 1 weeks after intervention
Maternal preventive behavior
Time Frame: Change from Baseline at 8 months after intervention
Item including that"Do you ask your child to brush his/her teeth?" The response was coded as zero (not/seldom/sometimes) or one (always). "How many times you help your child to brush his/her teeth every day?" The response was coded as zero (no/less than two times/day) or one (two or more times/day). "How long do you help your child brush his/her teeth every time?" The response was coded as zero (no/less than three minutes) or one (three or more minutes). "When was the last time that you took your child for a dental visit?" and "Why did you take your child for a dental visit?" The responses were coded as zero (last dental visit more than six months or dental visit for oral or tooth discomfort) or one (last dental visit six months or less and dental visit for regular checkup).
Change from Baseline at 8 months after intervention
Maternal caries-related knowledge
Time Frame: Change from Baseline at 1 weeks after intervention
Maternal caries preventive behaviors toward children were collected by questionnaire.Ten statements were used to evaluate mothers' caries preventive knowledge, such as "Dental plaque is a major factor for oral disease" and "The Bureau of National Health Insurance (BNHI) provides children with fluoride varnish twice a year." Possible scores ranged from zero to ten, with higher scores indicating a higher level of caries preventive knowledge. The Kuder-Richardson reliability test was 0.72 for this scale.
Change from Baseline at 1 weeks after intervention
Maternal caries-related knowledge
Time Frame: Change from Baseline at 8 months after intervention
Maternal caries preventive behaviors toward children were collected by questionnaire.Ten statements were used to evaluate mothers' caries preventive knowledge, such as "Dental plaque is a major factor for oral disease" and "The Bureau of National Health Insurance (BNHI) provides children with fluoride varnish twice a year." Possible scores ranged from zero to ten, with higher scores indicating a higher level of caries preventive knowledge. The Kuder-Richardson reliability test was 0.72 for this scale.
Change from Baseline at 8 months after intervention
Maternal attitude toward oral hygiene
Time Frame: Change from Baseline at 1 weeks after intervention
Maternal attitude toward oral hygiene were collect by questionnaire.Eleven statements measured mothers' attitude toward their children's oral hygiene, based on the research by Skeie et al. The responses were rated on a five-point Likert-scale ranging from one ("strongly disagree") to five ("strongly agree"), with the total possible score ranging from 11 to 55. Higher scores indicated more positive attitudes toward children's oral hygiene. Cronbach's α was 0.84 for this scale.
Change from Baseline at 1 weeks after intervention
Maternal attitude toward oral hygiene
Time Frame: Change from Baseline at 8 months after intervention
Maternal attitude toward oral hygiene were collect by questionnaire.Eleven statements measured mothers' attitude toward their children's oral hygiene, based on the research by Skeie et al. The responses were rated on a five-point Likert-scale ranging from one ("strongly disagree") to five ("strongly agree"), with the total possible score ranging from 11 to 55. Higher scores indicated more positive attitudes toward children's oral hygiene. Cronbach's α was 0.84 for this scale.
Change from Baseline at 8 months after intervention
Maternal self-efficacy toward oral hygiene
Time Frame: Change from Baseline at 1 weeks after intervention
The following three statements were used to evaluate mothers' self-efficacy toward children's oral hygiene, based on the research by Hsu et al. "It is easy for me to help my children brush their teeth"; "I can help my children brush their teeth before bedtime" and "I can take my children to visit a dentist regularly." The scores ranged from one ("strongly disagree") to four ("strongly agree"), with the total possible score ranging from three to twelve. High scores meant that mothers were confident that they could appropriately manage their children's oral hygiene behaviors. Cronbach's α was 0.72 for this scale.
Change from Baseline at 1 weeks after intervention
Maternal self-efficacy toward oral hygiene
Time Frame: Change from Baseline at 8 months after intervention
The following three statements were used to evaluate mothers' self-efficacy toward children's oral hygiene, based on the research by Hsu et al. "It is easy for me to help my children brush their teeth"; "I can help my children brush their teeth before bedtime" and "I can take my children to visit a dentist regularly." The scores ranged from one ("strongly disagree") to four ("strongly agree"), with the total possible score ranging from three to twelve. High scores meant that mothers were confident that they could appropriately manage their children's oral hygiene behaviors. Cronbach's α was 0.72 for this scale.
Change from Baseline at 8 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMUHIRB-2014-04-05(Ⅰ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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