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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03641885
Other study ID # IR.QUMS.REC.1396.601
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2018
Est. completion date November 1, 2018

Study information

Verified date December 2018
Source Qazvin University Of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 791
Est. completion date November 1, 2018
Est. primary completion date October 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 16 Years
Eligibility 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 Design


Intervention

Behavioral:
mothers and adolescents
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.
adolescents
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 control
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.

Locations

Country Name City State
Iran, Islamic Republic of Social Determinants of Health Research Center Qazvin

Sponsors (1)

Lead Sponsor Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in dental busing behavior using a self-reported questionnaire using a self-reported questionnaire baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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) baseline, 1 Months, 6 months follow-up
Secondary 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 baseline, 1 Months, 6 months follow-up
Secondary 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). baseline, 1 Months, 6 months follow-up
Secondary 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. baseline, 1 Months, 6 months follow-up
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