Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST).

NCT ID: NCT04923581

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-08

Study Completion Date

2023-11-30

Brief Summary

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In the current study, MOST approach is proposed, to engineer an oral health behavior modification intervention, to increase the engagement of mothers in brushing their pre-school children's teeth.

Detailed Description

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The first phase of this study will be the preparation phase. This will comprise the development of a conceptual framework and conducting a feasibility pilot study consisting of three intervention components: Motivational interviewing (MI), Oral health promotion messages (OHPm), and Storytelling (ST). The second phase of the study is the optimization phase which constitutes a factorial trial of the three selected intervention components (MI, OHPm and ST). Each component will be set at two levels: yes (the intervention is applied) vs no (the intervention is not applied).

Conditions

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Dental Caries in Children Early Childhood Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A factorial trial following the Multiphase optimization Strategy (MOST)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Condition 1

Participants will receive the constant component only.

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Condition 2

Participants will receive the constant component and storytelling videos .

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Condition 3

Participants will receive the constant component and oral health promotion messages.

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Condition 4

Participants will receive the constant component, oral health promotion messages, and storytelling videos.

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Condition 5

Participants will receive the constant component and motivational interview session.

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Condition 6

Participants will receive the constant component, motivational interview session, and storytelling videos.

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Condition 7

Participants will receive the constant component, motivational interview session, and oral health promotion messages.

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Condition 8

Participants will receive the constant component, motivational interview session, oral health promotion messages and storytelling videos

Group Type EXPERIMENTAL

Oral Health Behavioral Interventions

Intervention Type BEHAVIORAL

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Interventions

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Oral Health Behavioral Interventions

The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Has children between 2 and \<5 years of age
* Has children with high plaque index scores (PlI≄2 or visible plaque accumulation on maxillary anterior teeth).
* Literate and owns a mobile phone with already set-up or possibility to set-up Whats-App messenger application.
* Willing to participate in the study and receive periodic OHPm and ST videos.

Exclusion Criteria

* Mothers of children who are not willing to cooperate and show a definite negative behavior (Rating 1 Frankel's classification).
* Mothers of children who are physically disabled or medically compromised.
* Mothers of children in need of emergency dental treatments.
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role collaborator

Merna Ihab

OTHER

Sponsor Role lead

Responsible Party

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Merna Ihab

Teaching Assistant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Merna Ihab, B.Sc

Role: PRINCIPAL_INVESTIGATOR

Alexandria University, Faculty of Dentistry

Maha El Tantawi, PhD

Role: STUDY_DIRECTOR

Alexandria University, Faculty of Dentistry

Wafaa E. El Din, PhD

Role: STUDY_DIRECTOR

Alexandria University, Faculty of Dentistry

Locations

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Alexandria University, Faculty of Dentistry

Alexandria, , Egypt

Site Status

Department of Pediatric Dentistry and Dental Public Health, Alexandria University, Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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Ihab M, El Din WE, Ammar N, Yassin R, El Tantawi M. Using mHealth to promote parents' brushing of preschool children's teeth: a protocol for a randomized factorial trial using the Multi-phase Optimization Strategy (MOST). Trials. 2022 Jan 6;23(1):17. doi: 10.1186/s13063-021-05931-0.

Reference Type DERIVED
PMID: 34991701 (View on PubMed)

Other Identifiers

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MOST2021

Identifier Type: -

Identifier Source: org_study_id

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