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

NCT04923581 | Completed

• 1 other identifier: MOST2021
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Dental Caries in Children; Early Childhood Caries

Keywords

MOST, behavioural intervention, early childhood caries

Outcome Measures

Primary Outcomes (2)

• Change in the plaque index scores of participating children

  Measured by the Plaque index of Silness and Loe. Lower plaque scores indicate better oral hygiene

  at baseline, 3 and 6 months

• Change in children's frequency of toothbrushing and use of fluoridated toothpaste

  Using the World Health Organization questionnaire. Highrr tooth brushing frequency indicates better oral hygiene

  at baseline, 3 and 6 months

Study Arms (8)

Condition 1

EXPERIMENTAL

Participants will receive the constant component only.

Behavioral: Oral Health Behavioral Interventions

Condition 2

EXPERIMENTAL

Participants will receive the constant component and storytelling videos .

Behavioral: Oral Health Behavioral Interventions

Condition 3

EXPERIMENTAL

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

Behavioral: Oral Health Behavioral Interventions

Condition 4

EXPERIMENTAL

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

Behavioral: Oral Health Behavioral Interventions

Condition 5

EXPERIMENTAL

Participants will receive the constant component and motivational interview session.

Behavioral: Oral Health Behavioral Interventions

Condition 6

EXPERIMENTAL

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

Behavioral: Oral Health Behavioral Interventions

Condition 7

EXPERIMENTAL

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

Behavioral: Oral Health Behavioral Interventions

Condition 8

EXPERIMENTAL

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

Behavioral: Oral Health Behavioral Interventions

Interventions

Oral Health Behavioral Interventions 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 1; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merna Ihab: lead
• Alexandria University: collaborator

Study Sites (2)

Alexandria University, Faculty of Dentistry

Alexandria, Egypt

Location

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

Alexandria, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34991701 DERIVED

Study Officials

• Merna Ihab, B.Sc

  Alexandria University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

• Maha El Tantawi, PhD

  Alexandria University, Faculty of Dentistry

  STUDY DIRECTOR

• Wafaa E. El Din, PhD

  Alexandria University, Faculty of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: A factorial trial following the Multiphase optimization Strategy (MOST)

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 11, 2021
• Study Start: July 8, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)