Clinical trial NCT04891939: Development and Assessment of a Teacher-led Intervention in Preventing Tobacco Use Among the Youth in Ghana
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Reduction
Smoking Cessation
Smoking, Tobacco
Smoking Behaviors
Lead sponsor: Ghana Health Services
Sponsor class: OTHER_GOV
Collaborators: name: Kwame Nkrumah University of Science and Technology
First posted: 2021-05-19
Enrollment: 2314
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel assignments to either an intervention or control from randomly selected schools
Primary purpose: PREVENTION

Brief 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

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;

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in tobacco use
timeFrame: Immediately after intervention
measure: Change in tobacco use
timeFrame: 3 months post intervention
Secondary outcomes:
measure: Behavioral Change
timeFrame: Immediately after intervention
measure: Behavioral Change
timeFrame: 3 months post intervention
measure: Attitudinal Change
timeFrame: Immediately after intervention
measure: Attitudinal Change
timeFrame: 3 months post intervention
Other outcomes:
Locations:
Study officials:
References:
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