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Clinical Trial Protocol Iranian Registry of Clinical Trials

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Clinical Trial Protocol Iranian Registry of Clinical Trials Clinical Trial Protocol Iranian Registry of Clinical Trials 04 Oct 2021 The effect of two types of intervention (based on the principles of social marketing and traditional education) on increase in self-reported frequency and duration of tooth brushing of elementary school students: A controlled quasi-experimental study Protocol summary home or school, communication channels that were appropriate for these environments like face-to-face Study aim training sessions, printed material for use in the school, The aim of this study was to evaluate the effect of social training through parents, and the effect of parents on marketing approach versus the traditional method on their children were considered. Phase 4: Market analysis promotion of tooth brushing habits in primary school In this study, one of the supporting factors was the students of Kahak and Jafariyeh, Qom performance of some teachers that considered a day of Design the week as the “tooth brush day”. On this day, the This quasi-experimental controlled trial had a parallel teachers asked the students to bring their toothbrushes design. The study was conducted in the cities of Kahak and brush their teeth under the teacher’s supervision. and Jafariyeh, Qom, Iran. Considering the relatively small One of the identified competitors was the parents’ low number of students in the two cities, sampling was not level of oral health knowledge in Iran [14]. Another done and the whole target population entered the competitor was the common belief among the students census. 1318 students participated in the study and that brushing the teeth once a day is enough [15]. The enrolled in February 2017 and followed one and half second part of market analysis was implementation of months. market mix principles or 4P as the following: 1. Product: Settings and conduct The main product was prevention of tooth decay and the Intervention Group (Kahak) In this city, intervention was real product was tooth brushing two times a day for two done according to the social marketing approach. The minutes each time. 2. Price: The time spent in the class SMART model was used to organize different phases of (about 30 minutes), time spent on brushing the teeth social marketing in the following order [6, 13]: Phase 1: and commitment to completing the tooth brushing Preliminary planning The main problem, to overcome calendar were among the expenses that the participants which this study was designed, was lack of interest in met. 3. Place: The place that was considered for the tooth brushing with the proper length and frequency. intervention was the students’ schools and houses Therefore, the main objective of the study was to because they were easily accessible. 4. Promotion: All improve tooth-brushing habits as at least two times a the tools that were designed to persuade students to day for at least two minutes each time. The main method brush their teeth are placed in this group. These tools that was used for project assessment was a self-report were planned based on the results of the first checklist. checklist before and after the intervention and Phase 5: Development In this study, a sample of the comparison of the checklists. Phase 2: Audience analysis tools was provided to school managers and health Only the primary school students of the two cities were authorities to collect their comments. The intervention identified as the target population. To analyze the target tools were approved in all schools and no comments population’s beliefs and prioritization of the reasons for were received. Phase 6: Implementation In this phase, irregular or no tooth brushing from the perspective of the project was implemented as designed in the previous themselves or their parents, a checklist was provided to phases, and interventions were applied in the schools. At all students and its results (Table 1) were used in the beginning of this phase, a checklist containing designing the intervention tools. Phase 3: Channel questions on tooth-brushing habits was completed by the analysis Since most of the students’ time was spent at students to record their status before the intervention. 1 This checklist was completed by the parents of students Recruitment complete in grades 1 to 3 and by the students in grades 4-6. After Funding source the checklists were collected, the intervention was Funding of Tehran University of Medical Sciences for continued for one and a half months. Phase 7: Evaluation thesis and research projects In this study, considering the students’ presence at school, it was possible to convey messages to the target Expected recruitment start date population. On the other hand, due to the availability of 2017-02-25, 1395/12/07 teachers, they were requested to cooperate in the Expected recruitment end date assessment of the project and review the main concepts 2017-02-28, 1395/12/10 of the project with the students and check the tooth- Actual recruitment start date brushing calendar at least once a week. At the end of empty this phase, the students completed the tooth-brushing Actual recruitment end date habits checklist for the second time to evaluate the empty changes following the intervention. Control Group Trial completion date (Jafariyeh) The students in Jafariyeh completed the tooth- empty brushing habits checklist before the intervention (similar to students in Kahak). After collecting the checklists, Scientific title since this city was considered as the control group, a The effect of two types of intervention (based on the traditional intervention, i.e. pamphlet that was exactly principles of social marketing and traditional education) similar to the pamphlet distributed in Kahak, was on increase in self-reported frequency and duration of applied. Then, the changes were assessed through tooth brushing of elementary school students: A completing the checklist for a second time. controlled quasi-experimental study Participants/Inclusion and exclusion criteria Entry requirements: All primary school students (grade 1 Public title to 6) of Kahak and Jafariyeh in the 2016-2017 academic The application of social marketing to promote good year Non-entry requirements: Non-cooperation of the habits of brushing (at least twice a day, each time at students and their parents’ unwillingness least two minutes) Intervention groups Purpose Intervention group: All primary school students of Kahak Prevention city in the 2016-2017 academic year Control group: All Inclusion/Exclusion criteria primary school students of Jafariyeh city in the Inclusion criteria: 2016-2017 academic year Students enrolled in grades of one to six in elementary Main outcome variables schools of Kahak and Jafariye cities in the academic year Duration of tooth brushing Frequency of tooth brushing 2016-2017 Exclusion criteria: non-compliance or lack of consent of the student or General information parents Age Reason for update No age limit Acronym Gender IRCT registration information Both IRCT registration number: IRCT2016123131675N1 Registration date: 2017-07-26, 1396/05/04 Phase Registration timing: retrospective N/A Groups that have been masked No information Last update: 2018-03-05, 1396/12/14 Sample size Update count: 1 Target sample size: 1720 Registration date Randomization (investigator's opinion) 2017-07-26, 1396/05/04 Not randomized Registrant information Randomization description Name Blinding (investigator's opinion) AliAsghar Habibi Not blinded Name of organization / entity Blinding description Tehran University of Medical Sciences Placebo Country Not used Iran (Islamic Republic of) Assignment Phone Parallel +98 21 8801 4039 Other design features Email address [email protected] Secondary Ids Recruitment status empty 2 Ethics committees 1 Description 1 Intervention in intervention city (Kahak city): The use of social marketing principles such as use of adware, Ethics committee masterclass, distributed toothbrushes, timers, brochures, Name of ethics committee etc. based on the assessed needs of students with using Tehran University of Medical Sciences Ethics of SMART (Social marketing assessment and response Committee tool) model in order to promote good habits of brushing Street address (at least twice a day and each time at least two minutes) room No. 604, sixth floor, the Central Organization of Category Tehran University of Medical Sciences, St. Qods, Prevention Keshavarz Blvd, Tehran City 2 Tehran Province Description Tehran Intervention in the control city (Jafariye city): The use of Postal code traditional methods such as distributing pamphlets to 1417653761 increase the frequency and duration of brushing Approval date Category 2016-10-25, 1395/08/04 Prevention Ethics committee reference number IR.TUMS.VCR.REC.1395.852 Recruitment centers Health conditions studied 1 Recruitment center 1 Name of recruitment center Motahhari2 school of Kahak city Description of health condition studied Full name of responsible person Oral health advice and education (tooth brushing habit) Mr Esmaeily ICD-10 code Street address Z72.9, Z71 Zeynabieh St. ICD-10 code description City Problem related to lifestyle, unspecified---Other specified Kahak counselling Province Ghoum Primary outcomes Postal code 3735114640 Phone 1 +98 25 3422 3424 Description Email Frequency of tooth brushing [email protected] Timepoint Before and one month after intervention 2 Method of measurement Recruitment center Answering checklist (self-reported) Name of recruitment center Motahhari1 school of Kahak city 2 Full name of responsible person Mr Abarghooyi Description Street
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