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

NCT04562675 | Completed

• 1 other identifier: KMUHIRB-2014-04-05(Ⅰ)
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries,Dental

Keywords

Caries; immigrant; Lay health advisor; preventive behavior; oral hygiene

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Change from Baseline dmft at 8 months after intervention

Secondary Outcomes (8)

• Maternal preventive behavior

  Change from Baseline at 1 weeks after intervention

• Maternal preventive behavior

  Change from Baseline at 8 months after intervention

• Maternal caries-related knowledge

  Change from Baseline at 1 weeks after intervention

• Maternal caries-related knowledge

  Change from Baseline at 8 months after intervention

• Maternal attitude toward oral hygiene

  Change from Baseline at 1 weeks after intervention

Study Arms (2)

Intervention group (IG)

EXPERIMENTAL

LHA intervention group (IG)

Behavioral: LHA intervention

Control group (CG)

PLACEBO COMPARATOR

brochure-only control group (CG)

Other: brochure-only

Interventions

LHA intervention BEHAVIORAL

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.

Intervention group (IG)

brochure-only OTHER

brochure-only for control group (CG)

Control group (CG)

Eligibility Criteria

• Age: 22 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Vietnamese women whose children aged 2-6 years

You may not qualify if:

• None

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hsiao-Ling Huang

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 24, 2020
• Study Start: August 27, 2012
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share