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

Sponsor
Merna Ihab (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04923581
Collaborator
Alexandria University (Other)
160
1
8
6.3
25.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Oral Health Behavioral Interventions
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
A factorial trial following the Multiphase optimization Strategy (MOST)A factorial trial following the Multiphase optimization Strategy (MOST)
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.
Anticipated Study Start Date :
Aug 20, 2021
Anticipated Primary Completion Date :
Feb 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Condition 1

Participants will receive the constant component only.

Behavioral: 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.

Experimental: Condition 2

Participants will receive the constant component and storytelling videos .

Behavioral: 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.

Experimental: Condition 3

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

Behavioral: 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.

Experimental: Condition 4

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

Behavioral: 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.

Experimental: Condition 5

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

Behavioral: 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.

Experimental: Condition 6

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

Behavioral: 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.

Experimental: Condition 7

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

Behavioral: 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.

Experimental: Condition 8

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

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in the plaque index scores of participating children [at baseline, 3 and 6 months]

    Measured by the Plaque index (PII) of Silness and Loe

  2. Change in children's frequency of toothbrushing and use of fluoridated toothpaste [at baseline, 3 and 6 months]

    Using the World Health Organization (WHO) questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 (PlIā‰„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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria University, Faculty of Dentistry Alexandria Egypt

Sponsors and Collaborators

  • Merna Ihab
  • Alexandria University

Investigators

  • Principal Investigator: Merna Ihab, B.Sc, Alexandria University, Faculty of Dentistry
  • Study Director: Maha El Tantawi, PhD, Alexandria University, Faculty of Dentistry
  • Study Director: Wafaa E. El Din, PhD, Alexandria University, Faculty of Dentistry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merna Ihab, Teaching Assistant, Alexandria University
ClinicalTrials.gov Identifier:
NCT04923581
Other Study ID Numbers:
  • MOST2021
First Posted:
Jun 11, 2021
Last Update Posted:
Aug 11, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Merna Ihab, Teaching Assistant, Alexandria University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2021