Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103597248621 Date of Registration: 08/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Health Education Methods on Adolescents’ Susceptibility to Tobacco Uptake – Cluster-Randomised Control Trial
Official scientific title Susceptibility of Adolescents to Tobacco Use and the Relative Effectiveness of Health Education Methods – A Cluster-Randomized Control Trial
Brief summary describing the background and objectives of the trial Background: Tobacco use is associated with high mortality and morbidity; Killing more than half of its users. It is also worrisome that over 80% of the smokers reside in Low and Middle-Income Countries (LMICs). Tobacco use has attained the level of an epidemic in many LMICs. The epidemic is sustained by the addition of many youths and adolescents to the population of tobacco users, with more than 2,800 adolescents initiated daily. Tobacco use causes numerous oral and general health problems. The nicotine content is highly addictive and adversely affect brain development, which is still ongoing in adolescence. Despite all the tobacco control efforts, the prevalence of tobacco use continues to increase in Africa. This is mainly due to focus on getting smokers to quit, and neglect of preventing tobacco uptake by adolescents. Tobacco cessation programs have thus yielded little or no success because of the addictive effect of tobacco. It is imperative to shift attention to preventing non-smokers, especially adolescents, who are susceptible to tobacco smoking, from taking up the habit. Although different avenues are available to prevent adolescents from initiating tobacco uptake, the school has given promising outcomes. Different school-based tobacco prevention interventions have been evaluated with successes in preventing adolescents from initiating tobacco uptake in developed countries. It is, however, unknown, which of these methods is most appropriate for low resource settings like Nigeria. A country like Nigeria, lacking in both human (health professionals) and financial resources, needs to adopt an intervention method that is not only effective but also sustainable. The objective of the study: To compare the effectiveness of dentist-led lecture and self-directed learning methods of health education on school-going adolescents’ susceptibility to tobacco use in Ibadan, Oyo State, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HEATS
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 15/02/2021
Actual trial start date 26/04/2021
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 17/12/2021
Anticipated target sample size (number of participants) 720
Actual target sample size (number of participants) 720
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Self directed method of learning One session 45 minutes All the selected students in this group will be given at least two customized notebooks. Information on the constituents, oral and general health effects of tobacco use, as well as messages depicting benefits of quitting tobacco use will be presented graphically and in writing on the front and back cover pages of the notebooks. Posters with similar information as the notebooks will be pasted on the walls of the classrooms of the selected students. The posters and notebooks will be distributed about the same time that the researcher is conducting the first round of training sessions to those in the dentist-led group. The researcher/research assistants will be responsible for the distribution of the notebooks and posters, but the researcher/research assistants will not initiate any discussions with the students. The selected students per school will be assembled in the hall for about 30 minutes, like the dentist-led group. The reason is to guarantee a protected time for the students during which they could study/focus on the educational materials. The protected time will also ensure that the main difference between the two groups will be the lecture by the researcher. The participants will not be prevented from asking one another questions, but no tobacco-related questions will be answered by the researcher. 360
Control Group Dentistled health education lectures One session 45 minutes Participants in this intervention group will receive health education lectures conducted by a trained dentist (researcher). The participants will receive one session of lectures. The period for the training sessions will be discussed with the school principal, such that periods, where all the students will be free of classwork, will be chosen. The training session will last for about 45 minutes and will involve the delivery of the lecture (35 minutes) and questions and answers (10 minutes). The lecture will cover the following areas as contained in the standardized manual: constituents and types of tobacco products (smoked and smokeless), the adverse oral and general health effects of tobacco use, and clarifications on the common erroneous perceptions about the use of tobacco among adolescents. 360 Active-Treatment of Control Group
Experimental Group Self directed method of learning One session 45 minutes All the selected students in this group will be given at least two customized notebooks. Information on the constituents, oral and general health effects of tobacco use, as well as messages depicting benefits of quitting tobacco use will be presented graphically and in writing on the front and back cover pages of the notebooks. Posters with similar information as the notebooks will be pasted on the walls of the classrooms of the selected students. The posters and notebooks will be distributed about the same time that the researcher is conducting the first round of training sessions to those in the dentist-led group. The researcher/research assistants will be responsible for the distribution of the notebooks and posters, but the researcher/research assistants will not initiate any discussions with the students. The selected students per school will be assembled in the hall for about 30 minutes, like the dentist-led group. The reason is to guarantee a protected time for the students during which they could study/focus on the educational materials. The protected time will also ensure that the main difference between the two groups will be the lecture by the researcher. The participants will not be prevented from asking one another questions, but no tobacco-related questions will be answered by the researcher. 360
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
School-related criteria  The secondary schools must be located within the three selected LGAs included in the study.  The secondary schools must have classes up to the SSS 1 classes. Student-related criteria  The participants must be adolescents (10-19 years).  Participants will be students attending either a public or private secondary school.  The students (male and female) must be in the SSS 1 classes. School-related criteria  Secondary schools not registered with the State Government will be excluded from the study  Schools whose Principals do not agree to their schools’ participation in the study, despite detailed explanation and advocacy effort by the researcher.  Schools that have offered structured tobacco-related health education in the past 12 months.  Schools without an adequate number of students in the classes of interest (SSS 1) will also be excluded from the study. This information will be ascertained by asking the Principals of the selected schools. Student-related criteria  Consenting adolescents whose parents or legal guidance refuse their participation in the study will be excluded from the study.  Students who do not intend to remain in the school throughout the duration of the study (data collection and interventions)  Students who are not adolescents Adolescent: 13 Year(s)-17 Year(s) 10 Year(s) 19 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/08/2020 University of Ibadan and University College Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Ibadan College of Medicine Building, University College Hospital, Queen Elizabeth Road Ibadan 200212 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/01/2020 University of Ibadan and University College Hospital Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University of Ibadan College of Medicine Building, University College Hospital, Queen Elizabeth Road Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Susceptibility of the participants to tobacco use/cigarette smoking Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Secondary Outcome Participants knowledge of the contents, oral, and general health effects of tobacco use Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Secondary Outcome Participants perception of tobacco use based on the constructs of the Health Belief Model Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Primary Outcome Susceptibility of the participants to tobacco use/cigarette smoking Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Secondary Outcome Participants knowledge of the contents, oral, and general health effects of tobacco use Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Secondary Outcome Participants perception of tobacco use based on the constructs of the Health Belief Model Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University College Hospital Queen Elizabeth Road Ibadan 200212 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Omotayo Francis FAGBULE Department of Periodontology and Community Dentistry, University College Hospital Ibadan 200212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Omotayo Francis FAGBULE Flat C165 Circular Road, University College Hospital Ibadan 200212 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Folake Lawal Department of Periodontology and Community Dentistry, University College Hospital Ibadan 200212 Nigeria
Professor Gbemisola Oke Department of Periodontology and Community Dentistry, University College Hospital Ibadan 200212 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omotayo Fagbule ffagbule@gmail.com +2348037699380 Flat C165, Circular Road, University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Specialist Community Dentist and Tobacco Control Advocate
Role Name Email Phone Street address
Public Enquiries Ejiro Idiga idigaejiro@gmail.com +2348126434203 Department of Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Registrar Community Dentist
Role Name Email Phone Street address
Scientific Enquiries Folake Lawal folakemilawal@yahoo.com +2348023658988 Department of Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant Community Dentist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be made available on request. Informed Consent Form,Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 18/09/2023 The trial was approved in March 2021 26 Apr 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 18/09/2023 The actual duration of data collection and intervention was shorter than initially estimated. 17 Dec 2021
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 13/06/2025 The original trial protocol included three study arms (Dentist-led health talk, Self-directed learning, and a Control group) with an intended sample size of 1,080 participants (360 per group). However, based on the recommendation of the Dissertation Committee during the approval process, the control arm was removed. The rationale was that the control group would not be receiving any significant educational benefit during the study period, and including such a group could raise ethical concerns in a school-based intervention. Accordingly, the trial was implemented with two arms only: Dentist-led and Self-directed interventions, each with 360 participants, giving a total sample size of 720. All other study procedures, outcomes, and timelines were maintained as initially proposed. The trial registry is being updated to reflect this protocol amendment for transparency and consistency with the final implementation and reporting. 1080 720
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 18/09/2023 One of the groups (with no intervention) was removed following the recommendation of experts in ethics. 720
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 18/09/2023 The study has been concluded Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 13/06/2025 The initial plan was to use simple randomization by coin-tossing or dice-rolling. However, during actual implementation, this method was found to be impractical due to the large number of eligible schools in the selected Local Government Areas (LGAs). Manual randomization was not feasible, and there was a risk of allocation bias. To ensure a more efficient and transparent process, randomization was instead conducted at the cluster level using a web-based randomization tool. Schools were stratified by type (public vs. private) prior to allocation. This approach provided better allocation concealment and balance between groups, in line with best practices in cluster randomized trials. Simple randomization using by using procedures such as coin-tossing or dice-rolling Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification
Section Name Field Name Date Reason Old Value Updated Value
Study Design Stratification factors 13/06/2025 The initial plan was to use simple randomization by coin-tossing or dice-rolling. However, during actual implementation, this method was found to be impractical due to the large number of eligible schools in the selected Local Government Areas (LGAs). Manual randomization was not feasible, and there was a risk of allocation bias. To ensure a more efficient and transparent process, randomization was instead conducted at the cluster level using a web-based randomization tool. Schools were stratified by type (public vs. private) prior to allocation. This approach provided better allocation concealment and balance between groups, in line with best practices in cluster randomized trials. School type
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 13/06/2025 The originally selected option ("Sealed opaque envelopes") was not used in practice. Instead, allocation was conducted centrally using a web-based random sequence generator. The randomization sequence was held by an independent researcher who was not involved in enrollment or intervention delivery, ensuring allocation concealment. This aligns with best practices in cluster randomization. Sealed opaque envelopes Allocation was determined by the holder of the sequence who is situated off site
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/06/2025 The original protocol specified two contacts for each intervention arm (a baseline session and a second contact two weeks later). During piloting and consultations with school principals, it became clear that (i) all planned learning objectives could be achieved in a single 45-minute session, and (ii) schools’ tight academic calendars would not allow the release of pupils for a second period within the term. To respect institutional constraints and minimise disruption to teaching schedules, both intervention arms were delivered once only on the same day, with no two-week follow-up session or second distribution. All other study procedures, outcomes, and follow-up timelines remained unchanged. Experimental Group, Self directed method of learning, Two sessions , 45 minutes, All the selected students in this group will be given at least two customized notebooks. Information on the constituents, oral and general health effects of tobacco use, as well as messages depicting benefits of quitting tobacco use will be presented graphically and in writing on the front and back cover pages of the notebooks. Posters with similar information as the notebooks will be pasted on the walls of the classrooms of the selected students. The posters and notebooks will be distributed about the same time that the researcher is conducting the first round of training sessions to those in group 1. The researcher will be responsible for the distribution of the notebooks and posters, but the researcher will not initiate any discussions with the students. The selected students per school will be assembled in the hall for about 30 minutes, like the dentist-led group. The reason is to guarantee a protected time for the students during which they could study/focus on the educational materials. The protected time will also ensure that the main difference between the two groups will be the lecture by the researcher. The participants will not be prevented from asking one another questions, but no tobacco-related questions will be answered by the researcher. Follow-up session of the intervention: Like in group 1, after the first session, there will be one follow-up session, which will also take place after two weeks. During the follow-up visit, the researcher will give the study participants another set of customized notebooks, and replace any poster that may be damaged or missing from the classroom walls. , 360, Experimental Group, Self directed method of learning, One session , 45 minutes, All the selected students in this group will be given at least two customized notebooks. Information on the constituents, oral and general health effects of tobacco use, as well as messages depicting benefits of quitting tobacco use will be presented graphically and in writing on the front and back cover pages of the notebooks. Posters with similar information as the notebooks will be pasted on the walls of the classrooms of the selected students. The posters and notebooks will be distributed about the same time that the researcher is conducting the first round of training sessions to those in the dentist-led group. The researcher/research assistants will be responsible for the distribution of the notebooks and posters, but the researcher/research assistants will not initiate any discussions with the students. The selected students per school will be assembled in the hall for about 30 minutes, like the dentist-led group. The reason is to guarantee a protected time for the students during which they could study/focus on the educational materials. The protected time will also ensure that the main difference between the two groups will be the lecture by the researcher. The participants will not be prevented from asking one another questions, but no tobacco-related questions will be answered by the researcher. , 360,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/09/2023 Experts recommended that this group serve as the Control group since oral health lectures are the "usual practice" of delivering educational interventions. They explained that since the study objective is to compare the effectiveness of self-directed learning and lectures, there is no need for a Control Group with no intervention/benefit. Control Group, Dentistled health education lectures, One session, 45 minutes, Participants in this intervention group will receive health education lectures conducted by a trained dentist (researcher). The participants will receive one session of lectures. The period for the training sessions will be discussed with the school principal, such that periods, where all the students will be free of classwork, will be chosen. The training session will last for about 45 minutes and will involve the delivery of the lecture (35 minutes) and questions and answers (10 minutes). The lecture will cover the following areas as contained in the standardized manual: constituents and types of tobacco products (smoked and smokeless), the adverse oral and general health effects of tobacco use, and clarifications on the common erroneous perceptions about the use of tobacco among adolescents. , 360, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 13/06/2025 The original trial protocol included three study arms (Dentist-led health talk, Self-directed learning, and a Control group) with an intended sample size of 1,080 participants (360 per group). However, based on the recommendation of the dissertation committee during the ethical and academic approval process, the control arm was removed. The rationale was that the control group would not receive any meaningful educational intervention during the study period, and including such a group could raise ethical concerns in a school-based setting. As such, the study was implemented with two arms only—Dentist-led and Self-directed interventions—each with 360 participants, for a total sample size of 720. All other study procedures, outcomes, and timelines remained consistent with the original protocol. This update ensures transparency and alignment between the trial registry and the final study implementation. Control Group, Control, Nil, Nil, In the control group, baseline data will be collected. This will be followed by health education on tooth cleaning and other personal hygiene practices that will be given to the study participants. The session will follow the same approach as the intervention groups, with the only difference being the content (tobacco-related messages) and the absence of tobacco-customized notebooks and posters. After the final data collection, a session of tobacco-related health education will be given to the study participants, along with one customized notebook with tobacco-related information. Follow-up sessions of the health talk: There will be no follow-up training visit for this group. Although, they be followed up till the end of the study, and two further surveys (immediate post-intervention and final surveys) would be conducted as with the intervention groups., 360, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 25/08/2025 To provide specific details as requested by the reviewer. Primary Outcome, Susceptibility of the participants to tobacco use/cigarette smoking, Three Primary Outcome, Susceptibility of the participants to tobacco use/cigarette smoking, Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 25/08/2025 To provide specific details as requested Secondary Outcome, Participants knowledge of the contents, oral, and general health effects of tobacco use, Three Secondary Outcome, Participants knowledge of the contents, oral, and general health effects of tobacco use, Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 25/08/2025 To provide more details as requested. Secondary Outcome, Participants perception of tobacco use based on the constructs of the Health Belief Model, Three Secondary Outcome, Participants perception of tobacco use based on the constructs of the Health Belief Model, Three: Baseline, Immediate Post-Intervention, and Six-Months Post-Intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/03/2021 Minor update on the address. TRUE, University of Ibadan and University College Hospital Ethical Committee, Queen Elizabeth Road, Ibadan, 200212, Nigeria, , 26 Aug 2020, +2348033264593, uiuchec@gmail.com, 14676_13017_4737.pdf TRUE, University of Ibadan and University College Hospital Research Ethics Committee, University of Ibadan College of Medicine Building, University College Hospital, Queen Elizabeth Road, Ibadan, 200212, Nigeria, , 26 Aug 2020, +2348033264593, uiuchec@gmail.com, 14676_13017_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/03/2021 No changes made. The attached letter of ethical approval should have been included initially. I was an oversight. TRUE, University of Ibadan and University College Hospital Ethics Committee, College of Medicine Building, University College Hospital, Queen Elizabeth Road, Ibadan, 200212, Nigeria, , 14 Jan 2020, +2348033264593, uiuchec@gmail.com, 14676_13086_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/03/2021 Minor update of the address TRUE, University of Ibadan and University College Hospital Ethics Committee, College of Medicine Building, University College Hospital, Queen Elizabeth Road, Ibadan, 200212, Nigeria, , 14 Jan 2020, +2348033264593, uiuchec@gmail.com, 14676_13086_4737.pdf TRUE, University of Ibadan and University College Hospital Research Ethics Committee, University of Ibadan College of Medicine Building, University College Hospital, Queen Elizabeth Road, Ibadan, 200212, Nigeria, , 14 Jan 2020, +2348033264593, uiuchec@gmail.com, 14676_13086_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 07/03/2021 I got clarification from the Trial Reviewer' comments Dr. Omotayo Francis FAGBULE, Department of Periodontology and Community Dentistry, University College Hospital, Ibadan, 200212, Nigeria, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 07/03/2021 Based on the clarification from the reviewer's comments Dr. Folake Lawal, Department of Periodontology and Community Dentistry, University College Hospital, Ibadan, 200212, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 07/03/2021 Based on the clarifications from the reviewer's comments. Professor Gbemisola Oke, Department of Periodontology and Community Dentistry, University College Hospital, Ibadan, 200212, Nigeria