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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103802475677 Date of Approval: 08/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of health education on adolescents’ future smoking intentions
Official scientific title Effect of health education on adolescents’ future smoking intentions – a randomised control trial
Brief summary describing the background and objectives of the trial BACKGROUND: Tobacco is estimated to kill half of its users, and about 90% of adult smokers started during adolescence. To date, efforts in Africa to encourage adolescents to quit the tobacco habit have had limited successes. While tobacco control advocates are still battling to reduce the increasing prevalence of tobacco smoking in Africa, we continue to have more adolescents initiating the habit. Even more, are nursing the ambition of smoking in the future. Though getting smokers to quit is a common way of reducing smoking prevalence, another way is to prevent non-smokers from initiating the habit. However, this method of tobacco control is not common in Africa. Tobacco use is very addictive, which partly explains why tobacco cessation has been difficult. In contrast, tobacco uptake prevention targets non-smokers, without addiction, thus offering a better chance of success. Studies have shown that tobacco intervention (based on providing tobacco-related health education to the participants) aimed at prevention was more successful than cessation. The prevalence of tobacco use among adolescents has increased considerably in the last decade, with average national prevalence being 10.4%. Worst still, a lot of adolescents are nursing the intention of initiating the habit. A study among in-school adolescents in Lagos reported the prevalence of smoking intention as 18.6%; emphasizing the urgent need to prevent tobacco uptake among adolescents. Hence, this study aims to assess the effect of tobacco-related health education intervention on adolescents smoking intention. METHODOLOGY: The study will be as a randomised control trial conducted among in-school adolescents in secondary schools located in the metropolis of Ibadan, Oyo State. The study participants numbering about 720 across eight schools from two Local Government Areas (LGAs) in Ibadan metropolis, will be rand
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HAIST
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
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 01/06/2021
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education One sessions 45 minutes The intervention will take place after the baseline data has been collected, analyzed, and the results used to modify the manual for the intervention. Participants randomized to the intervention group will receive tobacco-related health education. The participants will receive one session of health education. The health education will be delivered in the school halls, and all the selected students will be invited to the lectures at mutually convenient times. The training session will last for about 45 minutes, and it will involve the delivery of the lecture (35 minutes) and questions and answers (10 minutes). The interactive session will include a question and answer session to ensure participation and better understanding. The session's duration has been limited to 45 minutes because this is the usual time for a session of class lectures in secondary schools. The researcher does not want the study participants to spend longer than this time because of their limited attention span and to avoid a significant loss of time needed for their other school activities. The researcher had also practiced giving the lectures and found out that about 30–35 minutes were needed to deliver the complete lecture module. This leaves at least 10 minutes for questions and discussion. Interactive educational programs are found to be more effective at preventing tobacco use among adolescents. Thus, the lecture mode will encourage maximum participation by the students. If the researcher cannot cover the whole module in the scheduled 45 minutes, this will be done in the follow-up sessions. The researcher’s experience during the pilot study will further guide the allotted time for the sessions. The health talk will cover the following areas as contained in the training manual: tobacco contents and types/forms (smoked, smokeless), and oral and general health effects 360
Control Group Control Nil After the baseline data is collected, health education on oral hygiene practices will be given to the study participants. Education on oral hygiene practices is aimed at improving the participants’ oral care practices. The lecture will follow the same approach as the tobacco-related lectures, with the only difference being the tobacco-related content and the absence of tobacco-customized notebooks and posters. After the final (third) evaluation, a session of tobacco-related oral health education will be given to the study participants. Follow-Up: There will be no follow-up visits for further lectures/health education to participants in this group. 360 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. The secondary schools must be located within the two selected LGAs included in the study. In 4.5 above only Two LGAs will be selected 2. The secondary schools must have classes up to the SSS 1 classes. 3. Participants will be students attending either a public or private secondary school. 4. The participants must be adolescents (age 10 – 19 years20). 5. The students (male and female) must be in the SSS 1 classes. 6. The secondary schools must have classes up to the SSS 1 classes. 1. Secondary schools not registered with the State Government will be excluded from the study 2. Schools whose principals do not agree to their schools’ participation in the study, despite detailed explanation and advocacy effort by the researcher. 3. Consenting adolescents whose parents or legal guidance refuse their participation in the study will be excluded from the study. 4. Students who do not intend to remain in the school throughout the duration of the study (data collection and interventions) 5. Schools that have offered structured tobacco-related health education in the past 12 months. 6. Schools without an adequate number of students in the class of interest (SSS 1) will be excluded from the study. This information will be ascertained by asking the principal of the selected schools. 7. Students who are not adolescents as defined by the WHO (between the ages of 10 – 19 years). Adolescent: 13 Year-18 Year 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 17/03/2020 University of Ibadan and University College Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
University College Hospital, Queen Elizabeth Road Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adolescents smoking intention 3
Secondary Outcome Knowledge of constituents, oral and general health effects of tobacco use 3
Secondary Outcome Perception of tobacco use 3
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, Queen Elizabeth Road Ibadan 200212 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Omotayo Francis Fagbule Periodontology and Community Dentistry, University College Hospital Ibadan Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Olushola Ibiyemi Department of Periodontology and Community Dentistry, University College Hospital, Queen Elizabeth Road Ibadan 200212 Nigeria
Dr. Mary Osuh Department of Periodontology and Community Dentistry, University College Hospital, Queen Elizabeth Road Ibadan 200212 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omotayo Fagbule ffagbule@gmail.com +2348037699380 Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Specialist Community Dentist and Tobacco control advocate
Role Name Email Phone Street address
Scientific Enquiries Mary Osuh meosuh2@gmail.com +2348035797011 Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Consultant Community Dentistry
Role Name Email Phone Street address
Public Enquiries Olubunmi Oni ireayodent@yahoo.com +2348033538267 Periodontology and Community Dentistry, University College Hospital
City Postal code Country Position/Affiliation
Ibadan Nigeria Senior Registrar
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) 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