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

Effect of Optimized Behavioural Intervention Using The Multi-Phase Optimization Strategy (MOST) on Oral Hygiene Habits of Pre-school Children in Egypt.

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Caries in Children; Early Childhood Caries
• Intervention / Treatment: Behavioral: Oral Health Behavioral Interventions

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 Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merna Ihab, B.Sc; Phone Number: 00201141156952; Email: merna.ihab@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Not yet recruiting
    • Alexandria University, Faculty of dentistry
    • Contact: Merna Ihab; Phone Number: 00201141156952
  • Alexandria, Egypt
    • Recruiting
    • Department of Pediatric Dentistry and Dental Public Health, Alexandria University, Faculty of Dentistry
    • Contact: Ihab, BSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the plaque index scores of participating children	Measured by the Plaque index (PII) of Silness and Loe	at baseline, 3 and 6 months
Change in children's frequency of toothbrushing and use of fluoridated toothpaste	Using the World Health Organization (WHO) questionnaire	at baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: Merna Ihab
• Collaborators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: MOST, behavioural intervention, early childhood caries
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: MOST2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No