Caries,DentalNCT04562675
Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries
A study testing LHA intervention and brochure-only in people with Caries,Dental, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- LHA intervention and brochure-only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2012to 31 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Vietnamese women whose children aged 2-6 years
Who cannot join
- None
About this study
Official title: 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.
Read the 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
- Caries,Dental
- Being tested
- LHA intervention, brochure-only
- Keywords
- Caries, immigrant, Lay health advisor, preventive behavior, oral hygiene
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHA interventionBehavioural
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.
brochure-onlyOther
brochure-only for control group (CG)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (IG) | Experimental | LHA intervention group (IG) Receives: Behavioral: LHA intervention |
| Control group (CG) | Placebo comparator | brochure-only control group (CG) Receives: Other: brochure-only |
What is being measured
The primary outcome is the main question the study is designed to answer.
dmft index
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.
Measured: Change from Baseline dmft at 1 weeks after intervention
dmft index
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.
Measured: Change from Baseline dmft at 2 months after intervention
dmft index
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.
Measured: Change from Baseline dmft at 8 months after intervention
Secondary outcomes (8)
Maternal preventive behavior
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).
Measured: Change from Baseline at 1 weeks after intervention
Maternal preventive behavior
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).
Measured: Change from Baseline at 8 months after intervention
Maternal caries-related knowledge
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.
Measured: Change from Baseline at 1 weeks after intervention
Maternal caries-related knowledge
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.
Measured: Change from Baseline at 8 months after intervention
Maternal attitude toward oral hygiene
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.
Measured: Change from Baseline at 1 weeks after intervention
Maternal attitude toward oral hygiene
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.
Measured: Change from Baseline at 8 months after intervention
Maternal self-efficacy toward oral hygiene
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.
Measured: Change from Baseline at 1 weeks after intervention
Maternal self-efficacy toward oral hygiene
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.
Measured: Change from Baseline at 8 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start27 Aug 2012
- Primary completion31 Oct 2015
- Study completion31 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsiao-Ling Huang, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562675
- Sponsor's protocol ID
- KMUHIRB-2014-04-05(Ⅰ)
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of a Lay Health Advisor Intervention on Immigrant Children's Caries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04562675
- Acronym / sponsor ID
- KMUHIRB-2014-04-05(Ⅰ)
- Conditions
- Caries,Dental
- Keywords
- Caries, immigrant, Lay health advisor, preventive behavior, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 27 Aug 2012 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG) | Experimental | Behavioral: LHA interventionLHA intervention group (IG) |
| Control group (CG) | Placebo comparator | Other: brochure-onlybrochure-only control group (CG) |
Who may qualify
- Ages
- 22 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Vietnamese women whose children aged 2-6 years
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LHA 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. | Behavioural | Intervention group (IG) |
| brochure-onlybrochure-only for control group (CG) | Other | Control group (CG) |
Primary outcome
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.
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.
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.
8 secondary outcomes
Maternal preventive behavior
Time frame: Change from Baseline at 1 weeks after intervention
Maternal preventive behavior
Time frame: Change from Baseline at 8 months after intervention
Maternal caries-related knowledge
Time frame: Change from Baseline at 1 weeks after intervention
Maternal caries-related knowledge
Time frame: 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
Time frame: Change from Baseline at 8 months after intervention
Maternal self-efficacy toward oral hygiene
Time frame: Change from Baseline at 1 weeks after intervention
Maternal self-efficacy toward oral hygiene
Time frame: Change from Baseline at 8 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsiao-Ling Huang principal investigator
Kaohsiung Medical University
Questions about this trial
What is this clinical trial studying?
A study testing LHA intervention and brochure-only in people with Caries,Dental, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dmft index (time frame: Change from Baseline dmft at 1 weeks after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020; AzTrials last refreshed its copy on 7 Nov 2026.