Development and Assessment of a Teacher-led Intervention in Preventing Tobacco Use Among the Youth in Ghana

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04891939
• Other study ID #: RDD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: April 2022

Study information

• Verified date: May 2021
• Source: Ghana Health Services
• Contact: Divine D Logo, MPhil
• Phone: +233240015215
• Email: divine.logo[@]ghsmail.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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;

1. Evaluate the existing SHEP program on smoking prevention

2. Identify risk factors for smoking

3. Based on the above, design a novel strategy (Teacher-led) for prevention of smoking uptake and improved quit rate

4. Compare smoking rate within the intervention group and the control group

5. Make recommendations for policy action

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2314
• Est. completion date: April 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Smoking Behaviors
• Smoking Cessation
• Smoking Reduction
• Smoking, Tobacco

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ghana Health Services	Kwame Nkrumah University of Science and Technology

References & Publications (13)

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. — View Citation

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

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, Lindström 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. — View Citation

Jha P, Chaloupka FJ, Moore J, et al. (2006). Tobacco Addiction. In: Disease Control Priorities in Developing Countries. 2nd edition (Chapter 46; et al Jamison DT, Breman JG, Measham AR, Ed.). Washington (DC): The International Bank for Reconstruction and

Leiva A, Estela A, Bennasar-Veny M, Aguiló A, Llobera J, Yáñez 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. — View Citation

Leiva A, Estela A, Torrent M, Calafat A, Bennasar M, Yáñez 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. do — View Citation

Logo 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/ti — View Citation

Mayhew KP, Flay BR, Mott JA. Stages in the development of adolescent smoking. Drug Alcohol Depend. 2000 May 1;59 Suppl 1:S61-81. Review. — View Citation

Peto R. Smoking and death: the past 40 years and the next 40. BMJ. 1994 Oct 8;309(6959):937-9. — View Citation

So 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. — View Citation

U.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 an

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in tobacco use	Change from baseline tobacco use at 3-months	Immediately after intervention
Primary	Change in tobacco use	Change from baseline tobacco use at 6-months	3 months post intervention
Secondary	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.	Immediately after intervention
Secondary	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.	3 months post intervention
Secondary	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.	Immediately after intervention
Secondary	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.	3 months post intervention