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

Primary Purpose

Dental Caries in Children, Early Childhood Caries

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oral Health Behavioral Interventions
Sponsored by
Merna Ihab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring MOST, behavioural intervention, early childhood caries

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria for mother's of children enrolled in study:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Condition 1

Condition 2

Condition 3

Condition 4

Condition 5

Condition 6

Condition 7

Condition 8

Arm Description

Participants will receive the constant component only.

Participants will receive the constant component and storytelling videos .

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

Participants will receive the constant component and a motivational interview session.

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

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

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

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

Outcomes

Primary Outcome Measures

Change in the plaque index scores of participating children
Measured by the Plaque index (PII) of Silness and Loe
Change in children's frequency of toothbrushing and use of fluoridated toothpaste
Using the World Health Organization (WHO) questionnaire

Secondary Outcome Measures

Full Information

First Posted
June 8, 2021
Last Updated
July 18, 2023
Sponsor
Merna Ihab
Collaborators
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04923581
Brief Title
Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST).
Official Title
Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Merna Ihab
Collaborators
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children, Early Childhood Caries
Keywords
MOST, behavioural intervention, early childhood caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A factorial trial following the Multiphase optimization Strategy (MOST)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Condition 1
Arm Type
Experimental
Arm Description
Participants will receive the constant component only.
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
Participants will receive the constant component and storytelling videos .
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
Participants will receive the constant component and oral health promotion messages.
Arm Title
Condition 4
Arm Type
Experimental
Arm Description
Participants will receive the constant component and a motivational interview session.
Arm Title
Condition 5
Arm Type
Experimental
Arm Description
Participants will receive the constant component, oral health promotion messages and storytelling videos.
Arm Title
Condition 6
Arm Type
Experimental
Arm Description
Participants will receive the constant component, oral health promotion messages, storytelling videos, and a motivational interview session.
Arm Title
Condition 7
Arm Type
Experimental
Arm Description
Participants will receive the constant component, oral health promotion messages and a motivational interview session.
Arm Title
Condition 8
Arm Type
Experimental
Arm Description
Participants will receive the constant component, storytelling videos, and a motivational interview session.
Intervention Type
Behavioral
Intervention Name(s)
Oral Health Behavioral Interventions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the plaque index scores of participating children
Description
Measured by the Plaque index (PII) of Silness and Loe
Time Frame
at baseline, 3 and 6 months
Title
Change in children's frequency of toothbrushing and use of fluoridated toothpaste
Description
Using the World Health Organization (WHO) questionnaire
Time Frame
at baseline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for mother's of children enrolled in study: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Merna Ihab, B.Sc
Phone
00201141156952
Email
merna.ihab@alexu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merna Ihab, B.Sc
Organizational Affiliation
Alexandria University, Faculty of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maha El Tantawi, PhD
Organizational Affiliation
Alexandria University, Faculty of Dentistry
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Wafaa E. El Din, PhD
Organizational Affiliation
Alexandria University, Faculty of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Alexandria University, Faculty of Dentistry
City
Alexandria
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merna Ihab
Phone
00201141156952
Facility Name
Department of Pediatric Dentistry and Dental Public Health, Alexandria University, Faculty of Dentistry
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ihab, BSc

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34991701
Citation
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.
Results Reference
derived

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

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