Smoking ReductionNCT04891939
Development and Assessment of a Teacher-led Intervention in Preventing Tobacco Use Among the Youth in Ghana
A study testing Health education lessons (Smart-Kid's program) and School Health and Education Program (SHEP) in people with Smoking Reduction and Smoking Cessation, run by Ghana Health Services.
Trial summary
The main purpose of this experimental study is to compare the existing health education program for School Health and Education Program (SHEP) in the Junior High Schools with a new health education model (Smart-Kids') for the prevention of smoking initiation and to improve the quit rate among students in Upper East… Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Reduction, Smoking Cessation, Smoking, Tobacco
- What is being tested?
- Health education lessons (Smart-Kid's program) and School Health and Education Program (SHEP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,314 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Apr 2022
- 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 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schools with 60 students or more enrolment size
- Being part of the mainstream national educational system (public or private)
- Not currently or recently participated in any smoking prevention interventions.
Who cannot join
- Schools who did not agree to take part
- Schools with less than 60 students' enrolment size
- Student's inability to participate in the survey.
- Students' who did not give consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Assessment of a Teacher-led Intervention in Preventing Tobacco Use Among Junior High Students in the Upper East Region of Ghana: A Cluster Randomized Controlled Trial
The main purpose of this experimental study is to compare the existing health education program for School Health and Education Program (SHEP) in the Junior High Schools with a new health education model (Smart-Kids') for the prevention of smoking initiation and to improve the quit rate among students in Upper East Region of Ghana. The intervention will be based on the Theory of Triadic Influences (TTI) which involves the cultural environment in which adolescents mature, their immediate social situation, and intrapersonal differences. These three factors impact through different mediating variables, such as attitudes, normative beliefs, and self-efficacy, which eventually affect smoking intentions and smoking behavior as the outcome measures. The study design is a cluster randomized control trial. After baseline assessment, the investigators will randomize schools to receive the new health education for three months whiles the comparator (control group) will continue with the usual health education. The investigators will conduct a post-intervention assessment using the same questionnaire with unique identity codes linking each participant to their baseline assessments immediately at the end of the intervention. Final assessment will be done approximately three months after the intervention. The investigators will assess and compare the effectiveness of the new health model to the normal health promotion programs (SHEP).
The investigators hypothesized that there will be no significant differences observed between the new teacher-led health education program (the Smart-Kids Program) and the existing SHEP coordinator-led in preventing smoking uptake among the youth.
Read more
Alternatively, the new teacher-led health education program would facilitate the effects of the program on outcomes. on four key primary endpoints as follows:
- H1: The intervention study will result in a 30% reduction in smoking uptake
- H2: The intervention study will result in a 10% reduction in smokers
- H3. The intervention will increase knowledge of the harmful effects of tobacco use by 50%
- H4. The intervention will increase the willingness to quit smoking by 10% among smokers
Read the detailed description
Protecting adolescents against smoking initiation is a critical strategy for public health. It is a crucial strategy because it lessens tobacco-related disease burden on public health and importantly protects adolescents from becoming a smoker. Globally, almost 25 million and 13 million of the youth aged 13 to 15 years old currently smoke cigarettes and smokeless tobacco respectively.
Cigarette smoking during childhood and adolescence causes significant health problems, including respiratory illnesses, decreased physical fitness, and potential effects on lung growth and function. Of concern, every day about 80,000 to 100,000 children and adolescents initiate smoking, most of them in developing countries. Furthermore, among 1000 youth who smoke today, close to 500 will ultimately die of tobacco-related diseases.
In line with the global trends, Ghanaian youth smoking behavior is not too different from that of developed countries however, Ghana is considered to be at the beginning of the tobacco epidemic. Ghana having seen continuous reductions in tobacco use in the four rounds of the Global Youth Tobacco Survey (GYTS) conducted, the country still has close to one in ten youth continue to use a tobacco product. It is also, worth noting that, in addition to cigarette use, the youth are now into using other forms of tobacco products such as shisha, electronic cigarettes, and smokeless tobacco with higher usage among girls.
Significance of the study Prevention of tobacco use among the youth in a school setting is considered the most feasible and appropriate strategy for reducing tobacco consumption. The strategy, therefore, is intended to influence a large number of the youth not to start or/and assist to quit tobacco use. The intervention will prevent tobacco use, and provide the knowledge before transitioning to middle age, where they may be confronted with risky behaviors, such as tobacco use.
The intervention is primarily intended to lead to a reduction in smoking uptake and improve quit rate among the youth, and also increase knowledge about the harmful effects of tobacco use. The program is designed to effect positive behavior, self-efficacy, attitudinal change, and refrain from the use of harmful substances such as tobacco. In all these, the effects of the intervention may translate into a reduction in public health and medical costs associated with tobacco-related diseases.
Objective:
The primary objective of the study is to design, test, and implement a novel strategy for smoking prevention among youth in the Upper East Region Specifically;
- Evaluate the existing SHEP program on smoking prevention
- Identify risk factors for smoking
- Based on the above, design a novel strategy (Teacher-led) for prevention of smoking uptake and improved quit rate
- Compare smoking rate within the intervention group and the control group
- Make recommendations for policy action
- Being tested
- Health education lessons (Smart-Kid's program), School Health and Education Program (SHEP)
- Medical subject headings
- Smoking Reduction, Smoking Cessation, Tobacco Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education lessons (Smart-Kid's program)Other
The intervention is designed for all students, including never-smokers and students at high risk for smoking. Therefore, some contents are intended to influence those high-risk youth within the larger student audience by targeting the stages of the smoking acquisition process including, preparation, initiation, experimentation, regular use, and addiction (Mayhew et al., 2000). The intervention is also focused on addressing risk factors for smoking initiation and continue use (Hansen et al., 2015; So \& Yeo, 2015). These risk factors are, therefore, grouped into four major groups namely; personal factors, behavioral factors, environmental factors and sociodemographic factors
School Health and Education Program (SHEP)Other
The SHEP is the usual health and education program been done in all schools, and also has tobacco control component. This is will be used as the control for the intervention.
| Study group | Role | What they receive |
|---|---|---|
| The intervention Arm | Experimental | This arm will receive the novel intervention package for a period of three months to prevent smoking initiation and increase quit rate. The intervention will consist of 4 lessons which will be taught for about one hour each day. This will be segmented into two broad areas as knowledge and skill development. Under the knowledge-based program, participants will be taught, the global challenge of tobacco and tobacco products, correcting the erroneous impression about tobacco, the media and advertisement, and the harmful effects of smoking. The skill development program teaches about refusal skills (self-esteem, interpersonal relationship skills, and problem-solving skills). The participants will understand the tobacco advertising and marketing strategies; peer influence, and skills for resisting influences to smoke. Receives: Other: Health education lessons (Smart-Kid's program) |
| The Control Arm | Active comparator | The control arm will not receive novel intervention program but will continue with the usual School Health and Education program (SHEP) however, at the end of the intervention, all the materials will be sent to the control arm to also benefit from the lessons. Receives: Other: School Health and Education Program (SHEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tobacco use
Change from baseline tobacco use at 3-months
Measured: Immediately after intervention
Change in tobacco use
Change from baseline tobacco use at 6-months
Measured: 3 months post intervention
Secondary outcomes (4)
Behavioral Change
Behavior change from baseline at 3 months. The Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ) will be used to assess smoking behavioral change. The GN-SBQ is an 11-item, to evaluate the effect of behaviors associated with smoking. A higher score indicates favorable behavioral change towards tobacco use whiles a lower score shows unfavorable behavior change.
Measured: Immediately after intervention
Behavioral Change
Behavior change from baseline at 3 months . The Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ) will be used to assess smoking behavioral change. The GN-SBQ is an 11-item, to evaluate the effect of behaviors associated with smoking. A higher score indicates favorable behavioral change towards tobacco use whiles a lower score shows unfavorable behavior change.
Measured: 3 months post intervention
Attitudinal Change
Attitudinal change from baseline at 3 months. The Attitudes Towards Smoking Scale (ATS-18) will be used to assess the attitudinal change among participants on tobacco use. A higher score indicates positive attitudinal change towards tobacco use whiles a lower score shows negative attitude.
Measured: Immediately after intervention
Attitudinal Change
Attitudinal change from baseline at 3 months. The Attitudes Towards Smoking Scale (ATS-18) will be used to assess the attitudinal change among participants on tobacco use. A higher score indicates positive attitudinal change towards tobacco use whiles a lower score shows negative attitude.
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study startJun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Smoking ReductionStudies 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
- Model description
- A two-arm parallel assignments to either an intervention or control from randomly selected schools
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ghana Health Services
- Sponsor type
- Other government
- Collaborators
- Kwame Nkrumah University of Science and Technology
- Responsible party
- Principal investigator, Divine Darlington Logo, Ghana Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891939
- Sponsor's protocol ID
- RDD
- Status last verified
- May 2021
- First submitted
- 24 Apr 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is yet to be decided with the research team, it will be made available as soon as we decide on that.
Publications
Glover, E.D., Nilsson, F., Westin, A., and Glover, P.N. "Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ)." Paper presented at the 8th Annual Meeting of the Society for Research on Nicotine and Tobacco, Savannah, GA, 2002.
Hansen K, Lindstrom M, Rosvall M. Age at smoking initiation and self-rated health among second grade high school boys and girls in Scania, Sweden, a cross-sectional study. BMC Public Health. 2015 Nov 18;15:1143. doi: 10.1186/s12889-015-2457-z.
PubMed 26581335Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, editors. Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK11728/
PubMed 21250309Logo DD, Kyei-Faried S, Oppong FB, Ae-Ngibise KA, Ansong J, Amenyaglo S, Ankrah ST, Singh A, Owusu-Dabo E. Waterpipe use among the youth in Ghana: Lessons from the Global Youth Tobacco Survey (GYTS) 2017. Tob Induc Dis. 2020 May 29;18:47. doi: 10.18332/tid/120937. eCollection 2020.
PubMed 32547350Mayhew KP, Flay BR, Mott JA. Stages in the development of adolescent smoking. Drug Alcohol Depend. 2000 May 1;59 Suppl 1:S61-81. doi: 10.1016/s0376-8716(99)00165-9.
PubMed 10773438Leiva A, Estela A, Bennasar-Veny M, Aguilo A, Llobera J, Yanez AM. Effectiveness of a complex intervention on smoking in adolescents: A cluster-randomized controlled trial. Prev Med. 2018 Sep;114:88-94. doi: 10.1016/j.ypmed.2018.06.009. Epub 2018 Jun 22.
PubMed 29940292Leiva A, Estela A, Torrent M, Calafat A, Bennasar M, Yanez A. Effectiveness of a complex intervention in reducing the prevalence of smoking among adolescents: study design of a cluster-randomized controlled trial. BMC Public Health. 2014 Apr 16;14:373. doi: 10.1186/1471-2458-14-373.
PubMed 24739452So ES, Yeo JY. Factors Associated with Early Smoking Initiation among Korean Adolescents. Asian Nurs Res (Korean Soc Nurs Sci). 2015 Jun;9(2):115-9. doi: 10.1016/j.anr.2015.05.002. Epub 2015 May 27.
PubMed 26160239Peto R. Smoking and death: the past 40 years and the next 40. BMJ. 1994 Oct 8;309(6959):937-9. doi: 10.1136/bmj.309.6959.937. No abstract available.
PubMed 7950669U.S Surgeon General. (2014). U.S. Department of Health and Human Services. The Health Consequences of Smoking -50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center.
Ghana-GYTS. (2017a). Centers for Disease Control and Prevention. Global Youth Tobacco Survey (Vol. 10). Retrieved from https://nccd.cdc.gov/GTSSDataSurveyResources/Ancillary/DataReports.aspx?CAID=1
Atlas, T. T. (2019). WHO report on the global tobacco epidemic, 2017. Tobacco Atlas. Retrieved from https://tobaccoatlas.org/topic/youth/
Etter JF, Bergman MM, Humair JP, Perneger TV. Development and validation of a scale measuring self-efficacy of current and former smokers. Addiction. 2000 Jun;95(6):901-13. doi: 10.1046/j.1360-0443.2000.9569017.x.
PubMed 10946439
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of a Teacher-led Intervention in Preventing Tobacco Use Among Junior High Students in the Upper East Region of Ghana: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04891939
- Acronym / sponsor ID
- RDD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,314 participants (estimated)
- Lead sponsor
- Ghana Health ServicesOther government
- Collaborators
- Kwame Nkrumah University of Science and Technology
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 19 May 2021 (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.
The main purpose of this experimental study is to compare the existing health education program for School Health and Education Program (SHEP) in the Junior High Schools with a new health education model (Smart-Kids') for the prevention of smoking initiation and to improve the quit rate among students in Upper East Region of Ghana. The intervention will be based on the Theory of Triadic Influences (TTI) which involves the cultural environment in which adolescents mature, their immediate social situation, and intrapersonal differences. These three factors impact through different mediating variables, such as attitudes, normative beliefs, and self-efficacy, which eventually affect smoking intentions and smoking behavior as the outcome measures. The study design is a cluster randomized control trial. After baseline assessment, the investigators will randomize schools to receive the new health education for three months whiles the comparator (control group) will continue with the usual health education. The investigators will conduct a post-intervention assessment using the same questionnaire with unique identity codes linking each participant to their baseline assessments immediately at the end of the intervention. Final assessment will be done approximately three months after the intervention. The investigators will assess and compare the effectiveness of the new health model to the normal health promotion programs (SHEP).
The investigators hypothesized that there will be no significant differences observed between the new teacher-led health education program (the Smart-Kids Program) and the existing SHEP coordinator-led in preventing smoking uptake among the youth.
Alternatively, the new teacher-led health education program would facilitate the effects of the program on outcomes. on four key primary endpoints as follows:
- H1: The intervention study will result in a 30% reduction in smoking uptake
- H2: The intervention study will result in a 10% reduction in smokers
- H3. The intervention will increase knowledge of the harmful effects of tobacco use by 50%
- H4. The intervention will increase the willingness to quit smoking by 10% among smokers
Detailed description
Protecting adolescents against smoking initiation is a critical strategy for public health. It is a crucial strategy because it lessens tobacco-related disease burden on public health and importantly protects adolescents from becoming a smoker. Globally, almost 25 million and 13 million of the youth aged 13 to 15 years old currently smoke cigarettes and smokeless tobacco respectively.
Cigarette smoking during childhood and adolescence causes significant health problems, including respiratory illnesses, decreased physical fitness, and potential effects on lung growth and function. Of concern, every day about 80,000 to 100,000 children and adolescents initiate smoking, most of them in developing countries. Furthermore, among 1000 youth who smoke today, close to 500 will ultimately die of tobacco-related diseases.
In line with the global trends, Ghanaian youth smoking behavior is not too different from that of developed countries however, Ghana is considered to be at the beginning of the tobacco epidemic. Ghana having seen continuous reductions in tobacco use in the four rounds of the Global Youth Tobacco Survey (GYTS) conducted, the country still has close to one in ten youth continue to use a tobacco product. It is also, worth noting that, in addition to cigarette use, the youth are now into using other forms of tobacco products such as shisha, electronic cigarettes, and smokeless tobacco with higher usage among girls.
Significance of the study Prevention of tobacco use among the youth in a school setting is considered the most feasible and appropriate strategy for reducing tobacco consumption. The strategy, therefore, is intended to influence a large number of the youth not to start or/and assist to quit tobacco use. The intervention will prevent tobacco use, and provide the knowledge before transitioning to middle age, where they may be confronted with risky behaviors, such as tobacco use.
The intervention is primarily intended to lead to a reduction in smoking uptake and improve quit rate among the youth, and also increase knowledge about the harmful effects of tobacco use. The program is designed to effect positive behavior, self-efficacy, attitudinal change, and refrain from the use of harmful substances such as tobacco. In all these, the effects of the intervention may translate into a reduction in public health and medical costs associated with tobacco-related diseases.
Objective:
The primary objective of the study is to design, test, and implement a novel strategy for smoking prevention among youth in the Upper East Region Specifically;
- Evaluate the existing SHEP program on smoking prevention
- Identify risk factors for smoking
- Based on the above, design a novel strategy (Teacher-led) for prevention of smoking uptake and improved quit rate
- Compare smoking rate within the intervention group and the control group
- Make recommendations for policy action
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm parallel assignments to either an intervention or control from randomly selected schools
| Arm | Type | Receives |
|---|---|---|
| The intervention Arm | Experimental | Other: Health education lessons (Smart-Kid's program)This arm will receive the novel intervention package for a period of three months to prevent smoking initiation and increase quit rate. The intervention will consist of 4 lessons which will be taught for about one hour each day. This will be segmented into two broad areas as knowledge and skill development. Under the knowledge-based program, participants will be taught, the global challenge of tobacco and tobacco products, correcting the erroneous impression about tobacco, the media and advertisement, and the harmful effects of smoking. The skill development program teaches about refusal skills (self-esteem, interpersonal relationship skills, and problem-solving skills). The participants will understand the tobacco advertising and marketing strategies; peer influence, and skills for resisting influences to smoke. |
| The Control Arm | Active comparator | Other: School Health and Education Program (SHEP)The control arm will not receive novel intervention program but will continue with the usual School Health and Education program (SHEP) however, at the end of the intervention, all the materials will be sent to the control arm to also benefit from the lessons. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Schools with 60 students or more enrolment size
- Being part of the mainstream national educational system (public or private)
- Not currently or recently participated in any smoking prevention interventions.
Key exclusion criteria (4 listed)
- Schools who did not agree to take part
- Schools with less than 60 students' enrolment size
- Student's inability to participate in the survey.
- Students' who did not give consent
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 |
|---|---|---|
| Health education lessons (Smart-Kid's program)The intervention is designed for all students, including never-smokers and students at high risk for smoking. Therefore, some contents are intended to influence those high-risk youth within the larger student audience by targeting the stages of the smoking acquisition process including, preparation, initiation, experimentation, regular use, and addiction (Mayhew et al., 2000). The intervention is also focused on addressing risk factors for smoking initiation and continue use (Hansen et al., 2015; So \& Yeo, 2015). These risk factors are, therefore, grouped into four major groups namely; personal factors, behavioral factors, environmental factors and sociodemographic factors | Other | The intervention Arm |
| School Health and Education Program (SHEP)The SHEP is the usual health and education program been done in all schools, and also has tobacco control component. This is will be used as the control for the intervention. | Other | The Control Arm |
Primary outcome
Change in tobacco use
Time frame: Immediately after intervention
Change from baseline tobacco use at 3-months
Change in tobacco use
Time frame: 3 months post intervention
Change from baseline tobacco use at 6-months
4 secondary outcomes
Behavioral Change
Time frame: Immediately after intervention
Behavioral Change
Time frame: 3 months post intervention
Attitudinal Change
Time frame: Immediately after intervention
Attitudinal Change
Time frame: 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- BackgroundGlover, E.D., Nilsson, F., Westin, A., and Glover, P.N. "Glover-Nilsson Smoking Behavioral Questionnaire (GN-SBQ)." Paper presented at the 8th Annual Meeting of the Society for Research on Nicotine and Tobacco, Savannah, GA, 2002.
- Results publication: PubMed 26581335Hansen K, Lindstrom M, Rosvall M. Age at smoking initiation and self-rated health among second grade high school boys and girls in Scania, Sweden, a cross-sectional study. BMC Public Health. 2015 Nov 18;15:1143. doi: 10.1186/s12889-015-2457-z.
- Results publication: PubMed 21250309Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, editors. Disease Control Priorities in Developing Countries. 2nd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK11728/
- Results publication: PubMed 32547350Logo DD, Kyei-Faried S, Oppong FB, Ae-Ngibise KA, Ansong J, Amenyaglo S, Ankrah ST, Singh A, Owusu-Dabo E. Waterpipe use among the youth in Ghana: Lessons from the Global Youth Tobacco Survey (GYTS) 2017. Tob Induc Dis. 2020 May 29;18:47. doi: 10.18332/tid/120937. eCollection 2020.
- Results publication: PubMed 10773438Mayhew KP, Flay BR, Mott JA. Stages in the development of adolescent smoking. Drug Alcohol Depend. 2000 May 1;59 Suppl 1:S61-81. doi: 10.1016/s0376-8716(99)00165-9.
- Results publication: PubMed 29940292Leiva A, Estela A, Bennasar-Veny M, Aguilo A, Llobera J, Yanez AM. Effectiveness of a complex intervention on smoking in adolescents: A cluster-randomized controlled trial. Prev Med. 2018 Sep;114:88-94. doi: 10.1016/j.ypmed.2018.06.009. Epub 2018 Jun 22.
- Results publication: PubMed 24739452Leiva A, Estela A, Torrent M, Calafat A, Bennasar M, Yanez A. Effectiveness of a complex intervention in reducing the prevalence of smoking among adolescents: study design of a cluster-randomized controlled trial. BMC Public Health. 2014 Apr 16;14:373. doi: 10.1186/1471-2458-14-373.
- Results publication: PubMed 26160239So ES, Yeo JY. Factors Associated with Early Smoking Initiation among Korean Adolescents. Asian Nurs Res (Korean Soc Nurs Sci). 2015 Jun;9(2):115-9. doi: 10.1016/j.anr.2015.05.002. Epub 2015 May 27.
- Results publication: PubMed 7950669Peto R. Smoking and death: the past 40 years and the next 40. BMJ. 1994 Oct 8;309(6959):937-9. doi: 10.1136/bmj.309.6959.937. No abstract available.
- Results publicationU.S Surgeon General. (2014). U.S. Department of Health and Human Services. The Health Consequences of Smoking -50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center.
- Results publicationGhana-GYTS. (2017a). Centers for Disease Control and Prevention. Global Youth Tobacco Survey (Vol. 10). Retrieved from https://nccd.cdc.gov/GTSSDataSurveyResources/Ancillary/DataReports.aspx?CAID=1
- Results publicationAtlas, T. T. (2019). WHO report on the global tobacco epidemic, 2017. Tobacco Atlas. Retrieved from https://tobaccoatlas.org/topic/youth/
- Individual participant dataSharing planned: No. This is yet to be decided with the research team, it will be made available as soon as we decide on that.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Health education lessons (Smart-Kid's program) and School Health and Education Program (SHEP) in people with Smoking Reduction and Smoking Cessation, run by Ghana Health Services.
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 4 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: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Divine D Logo, MPhil (+233240015215, divine.logo@ghsmail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tobacco use (time frame: Immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891939, which also lists 13 linked publications.
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 19 May 2021.