- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Qazvin, Iran, Islamisk Republik, 3419759811
- Social Determinants of Health Research Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: mother and adolescents
an intervention group in which mothers and adolescents receive the intervention and questionnaires via Telegram social media
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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.
|
Eksperimentel: 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.
|
Aktiv komparator: active control
mothers and adolescents are in active control group and only receive the questionnaires
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
changes in dental busing behavior using a self-reported questionnaire
Tidsramme: baseline, 1 Months, 6 months follow-up
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using a self-reported questionnaire
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baseline, 1 Months, 6 months follow-up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
changes in self efficacy using a self-reported questionnaire
Tidsramme: baseline, 1 Months, 6 months follow-up
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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)
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baseline, 1 Months, 6 months follow-up
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changes in outcome expectancy
Tidsramme: baseline, 1 Months, 6 months follow-up
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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)
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baseline, 1 Months, 6 months follow-up
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changes in coping planning
Tidsramme: baseline, 1 Months, 6 months follow-up
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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)
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baseline, 1 Months, 6 months follow-up
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changes in action planning
Tidsramme: baseline, 1 Months, 6 months follow-up
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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)
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baseline, 1 Months, 6 months follow-up
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changes in risk perception
Tidsramme: 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)
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baseline, 1 Months, 6 months follow-up
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changes in self-monitoring
Tidsramme: baseline, 1 Months, 6 months follow-up
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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)
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baseline, 1 Months, 6 months follow-up
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changes in intention
Tidsramme: baseline, 1 Months, 6 months follow-up
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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)
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baseline, 1 Months, 6 months follow-up
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changes in perceived social support
Tidsramme: baseline, 1 Months, 6 months follow-up
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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)
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baseline, 1 Months, 6 months follow-up
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Changes in Community Periodontal Index (CPI)
Tidsramme: 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
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baseline, 1 Months, 6 months follow-up
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Changes in Turesky Modification of the Quigley-Hein Plaque Index
Tidsramme: baseline, 1 Months, 6 months follow-up
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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).
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baseline, 1 Months, 6 months follow-up
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Changes in Oral health related quality of life
Tidsramme: baseline, 1 Months, 6 months follow-up
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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.
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baseline, 1 Months, 6 months follow-up
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IR.QUMS.REC.1396.601
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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