NCT03641885

Brief Summary

Online social networking sites, such as Telegram, possess a number of useful features that could enhance oral health promotion interventions, including the ability of users to share personal information, which is aggregated and displayed to other users .This study is a longitudinal controlled trial that is designed to investigate the effectiveness of a multi-component intervention on improving oral health in adolescents and their mothers. Participants will be allocated in three groups with a) an intervention group in which mothers and children receive the intervention and questionnaires via Telegram, b) only the children receive the intervention via Telegram and mothers and children receive the questionnaires, and c) mothers and children are in active control group and only receive the questionnaires. The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on Oral health behaviors. There will be 3 assessment points in time, baseline, 1 month and 6 months after the interventions. The primary outcome of this study is to estimate the dyadic mechanisms between mothers and their children regarding improving oral health. Secondary outcome is to investigate whether oral health behavior did improve in the intervention groups in general and also to find the psychological mechanism behind the changes during the time of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
791

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

August 20, 2018

Last Update Submit

December 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • changes in dental busing behavior using a self-reported questionnaire

    using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

Secondary Outcomes (11)

  • changes in self efficacy using a self-reported questionnaire

    baseline, 1 Months, 6 months follow-up

  • changes in outcome expectancy

    baseline, 1 Months, 6 months follow-up

  • changes in coping planning

    baseline, 1 Months, 6 months follow-up

  • changes in action planning

    baseline, 1 Months, 6 months follow-up

  • changes in risk perception

    baseline, 1 Months, 6 months follow-up

  • +6 more secondary outcomes

Study Arms (3)

mother and adolescents

EXPERIMENTAL

an intervention group in which mothers and adolescents receive the intervention and questionnaires via Telegram social media

Behavioral: mothers and adolescents

adolescents

EXPERIMENTAL

an intervention group in which adolescents receive the intervention and questionnaires via Telegram social media

Behavioral: adolescents

active control

ACTIVE COMPARATOR

mothers and adolescents are in active control group and only receive the questionnaires

Behavioral: active control

Interventions

The intervention package will be sent to mothers and adolescents via Telegram social media. It contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. There will be 3 assessment points in time, baselines, 1 month and six months after interventions.

mother and adolescents
adolescentsBEHAVIORAL

The intervention package will be sent to only adolescents via Telegram social media. It contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. There will be 3 assessment points in time, baselines, 1 month and six months after interventions.

adolescents
active controlBEHAVIORAL

The active control group receives an information sheet regarding recommendations on oral health behavior via telegram. There will be 3 assessment points in time, with 1 month and six months in between.

active control

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • aged 12 to 16
  • possess a smartphone
  • able or willing to give informed consent

You may not qualify if:

  • They are not engaged in other oral-health education or research program.
  • They have no physical and/or mental disabilities that will impede their ability to perform their own oral hygiene activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social Determinants of Health Research Center

Qazvin, 3419759811, Iran

Location

MeSH Terms

Conditions

Health BehaviorAdolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Social Determinants of Health Research Center, Qazvin University of Medical Sciences

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 22, 2018

Study Start

February 1, 2018

Primary Completion

October 1, 2018

Study Completion

November 1, 2018

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations