Health BehaviorNCT03641885
A Social Media Intervention on Promoting Oral Heath Among Iranian Adolescents
A study testing mothers and adolescents and adolescents in people with Health Behavior and Adolescent Behavior, run by Qazvin University Of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Adolescent Behavior, Parent-Child Relations
- What is being tested?
- mothers and adolescents and adolescents
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 791 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2018to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- aged 12 to 16
- possess a smartphone
- able or willing to give informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Health Behavior, Adolescent Behavior, Parent-Child Relations
- Being tested
- mothers and adolescents, adolescents, active control
- Medical subject headings
- Health Behavior, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mothers and adolescentsBehavioural
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.
adolescentsBehavioural
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 controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mother and adolescents | Experimental | an intervention group in which mothers and adolescents receive the intervention and questionnaires via Telegram social media Receives: Behavioral: mothers and adolescents |
| adolescents | Experimental | an intervention group in which adolescents receive the intervention and questionnaires via Telegram social media Receives: Behavioral: adolescents |
| active control | Active comparator | mothers and adolescents are in active control group and only receive the questionnaires Receives: Behavioral: active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in dental busing behavior using a self-reported questionnaire
using a self-reported questionnaire
Measured: baseline, 1 Months, 6 months follow-up
Secondary outcomes (11)
changes in self efficacy using a self-reported questionnaire
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)
Measured: baseline, 1 Months, 6 months follow-up
changes in outcome expectancy
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)
Measured: baseline, 1 Months, 6 months follow-up
changes in coping planning
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)
Measured: baseline, 1 Months, 6 months follow-up
changes in action planning
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)
Measured: baseline, 1 Months, 6 months follow-up
changes in risk perception
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)
Measured: baseline, 1 Months, 6 months follow-up
changes in self-monitoring
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)
Measured: baseline, 1 Months, 6 months follow-up
changes in intention
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)
Measured: baseline, 1 Months, 6 months follow-up
changes in perceived social support
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)
Measured: baseline, 1 Months, 6 months follow-up
Changes in Community Periodontal Index (CPI)
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
Measured: baseline, 1 Months, 6 months follow-up
Changes in Turesky Modification of the Quigley-Hein Plaque Index
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).
Measured: baseline, 1 Months, 6 months follow-up
Changes in Oral health related quality of life
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.
Measured: baseline, 1 Months, 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Feb 2018
- Primary completion1 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 791 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir H Pakpour, Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641885
- Sponsor's protocol ID
- IR.QUMS.REC.1396.601
- Status last verified
- Dec 2018
- First submitted
- 20 Aug 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Social Media Intervention on Promoting Oral Heath Among Iranian Adolescents
- ClinicalTrials.gov ID
- NCT03641885
- Acronym / sponsor ID
- IR.QUMS.REC.1396.601
- Conditions
- Health Behavior, Adolescent Behavior, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 791 participants (actual)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mother and adolescents | Experimental | Behavioral: mothers and adolescentsan intervention group in which mothers and adolescents receive the intervention and questionnaires via Telegram social media |
| adolescents | Experimental | Behavioral: adolescentsan intervention group in which adolescents receive the intervention and questionnaires via Telegram social media |
| active control | Active comparator | Behavioral: active controlmothers and adolescents are in active control group and only receive the questionnaires |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- aged 12 to 16
- possess a smartphone
- able or willing to give informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mothers and adolescentsThe 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. | Behavioural | mother and adolescents |
| adolescentsThe 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. | Behavioural | adolescents |
| active controlThe 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. | Behavioural | active control |
Primary outcome
changes in dental busing behavior using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
using a self-reported questionnaire
11 secondary outcomes
changes in self efficacy using a self-reported questionnaire
Time frame: baseline, 1 Months, 6 months follow-up
changes in outcome expectancy
Time frame: baseline, 1 Months, 6 months follow-up
changes in coping planning
Time frame: baseline, 1 Months, 6 months follow-up
changes in action planning
Time frame: baseline, 1 Months, 6 months follow-up
changes in risk perception
Time frame: baseline, 1 Months, 6 months follow-up
changes in self-monitoring
Time frame: baseline, 1 Months, 6 months follow-up
changes in intention
Time frame: baseline, 1 Months, 6 months follow-up
changes in perceived social support
Time frame: baseline, 1 Months, 6 months follow-up
Changes in Community Periodontal Index (CPI)
Time frame: baseline, 1 Months, 6 months follow-up
Changes in Turesky Modification of the Quigley-Hein Plaque Index
Time frame: baseline, 1 Months, 6 months follow-up
Changes in Oral health related quality of life
Time frame: baseline, 1 Months, 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mothers and adolescents and adolescents in people with Health Behavior and Adolescent Behavior, run by Qazvin University Of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in dental busing behavior using a self-reported questionnaire (time frame: baseline, 1 Months, 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.