- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03641885
A Social Media Intervention on Promoting Oral Heath Among Iranian Adolescents
A Randomized Trial of a Social Media Intervention on Promoting Oral Heath Among Iranian Adolescents
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Qazvin, Iran, Islamic Republic of, 3419759811
- Social Determinants of Health Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged 12 to 16
- possess a smartphone
- able or willing to give informed consent
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mother and adolescents
an intervention group in which mothers and adolescents receive the intervention and questionnaires via Telegram social media
|
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.
|
Experimental: adolescents
an intervention group in which adolescents receive the intervention and questionnaires via Telegram social media
|
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.
|
Active Comparator: active control
mothers and adolescents are in active control group and only receive the questionnaires
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in dental busing behavior using a self-reported questionnaire
Time Frame: baseline, 1 Months, 6 months follow-up
|
using a self-reported questionnaire
|
baseline, 1 Months, 6 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in self efficacy using a self-reported questionnaire
Time Frame: baseline, 1 Months, 6 months follow-up
|
self efficacy will be assessed using a self-reported questionnaire with four items.
All items are rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree)
|
baseline, 1 Months, 6 months follow-up
|
changes in outcome expectancy
Time Frame: baseline, 1 Months, 6 months follow-up
|
outcome expectancy will be assessed using a self-reported questionnaire with three items.
All items are rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree)
|
baseline, 1 Months, 6 months follow-up
|
changes in coping planning
Time Frame: baseline, 1 Months, 6 months follow-up
|
coping planning will be assessed using a self-reported questionnaire with five items.
All items are rated on a 5-point scale ranging from 1 (not true) to 5 (totally true)
|
baseline, 1 Months, 6 months follow-up
|
changes in action planning
Time Frame: baseline, 1 Months, 6 months follow-up
|
action planning will be assessed using a self-reported questionnaire with five items.
All items are rated on a 5-point scale ranging from 1 (not true) to 5 (totally true)
|
baseline, 1 Months, 6 months follow-up
|
changes in risk perception
Time Frame: baseline, 1 Months, 6 months follow-up
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risk perception will be assessed using a self-reported questionnaire with three items.
All items are rated on a 5-point scale ranging from 1 (very unlikely) to 5 (very likely)
|
baseline, 1 Months, 6 months follow-up
|
changes in self-monitoring
Time Frame: baseline, 1 Months, 6 months follow-up
|
self-monitoring will be assessed using a self-reported questionnaire with four items.
All items are rated on a 5-point scale ranging from 1 (not at all true) to 5 (totally true)
|
baseline, 1 Months, 6 months follow-up
|
changes in intention
Time Frame: baseline, 1 Months, 6 months follow-up
|
Behavioral intention will be assessed using a self-reported questionnaire with four items.
All items are rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree)
|
baseline, 1 Months, 6 months follow-up
|
changes in perceived social support
Time Frame: baseline, 1 Months, 6 months follow-up
|
perceived social support will be assessed using a self-reported questionnaire with three items.
All items are rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree)
|
baseline, 1 Months, 6 months follow-up
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Changes in Community Periodontal Index (CPI)
Time Frame: baseline, 1 Months, 6 months follow-up
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The CPI scores are rated (0 = healthy gingiva, 1 = gingival bleeding, 2 = calculus, 3 = pocket from 4 to 5 mm, and 4 = pocket ≥6 mm
|
baseline, 1 Months, 6 months follow-up
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Changes in Turesky Modification of the Quigley-Hein Plaque Index
Time Frame: baseline, 1 Months, 6 months follow-up
|
The amount of plaque on each enamel block for each lingual and buccal surface is rated on a six point Likert-type scale ranging from 0 (no plaque) to 5 (plaque covering two-thirds or more of the crown of the tooth).
|
baseline, 1 Months, 6 months follow-up
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Changes in Oral health related quality of life
Time Frame: baseline, 1 Months, 6 months follow-up
|
The Pediatric Quality of Life Inventory TM (PedsQLTM) Oral Health Scale is used to examine Oral health related quality of life.
The scale comprises five items.
All responses are reverse scored and transformed into a 0-100-point scale with higher scores representing better Oral health related quality of life.
|
baseline, 1 Months, 6 months follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IR.QUMS.REC.1396.601
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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