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

NCT04891939 | Unknown DMC

• 1 other identifier: RDD
• Study Type: interventional
• Target: 2,314
• Locations: 0 countries
• Sites: N/A

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

Conditions

Smoking Reduction; Smoking Cessation; Smoking, Tobacco; Smoking Behaviors

Outcome Measures

Primary Outcomes (2)

• Change in tobacco use

  Change from baseline tobacco use at 3-months

  Immediately after intervention

• Change in tobacco use

  Change from baseline tobacco use at 6-months

  3 months post intervention

Secondary Outcomes (4)

• Behavioral Change

  Immediately after intervention

• Behavioral Change

  3 months post intervention

• Attitudinal Change

  Immediately after intervention

• Attitudinal Change

  3 months post intervention

Study Arms (2)

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.

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.

Other: School Health and Education Program (SHEP)

Interventions

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

The intervention Arm

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.

The Control Arm

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ghana Health Services: lead
• Kwame Nkrumah University of Science and Technology: collaborator

Related Publications (13)

• 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.

  BACKGROUND

• 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.

  PMID: 26581335 RESULT

• Jamison 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/

  PMID: 21250309 RESULT

• 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/tid/120937. eCollection 2020.

  PMID: 32547350 RESULT

• Mayhew 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.

  PMID: 10773438 RESULT

• Leiva 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.

  PMID: 29940292 RESULT

• Leiva 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.

  PMID: 24739452 RESULT

• 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.

  PMID: 26160239 RESULT

• Peto 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.

  PMID: 7950669 RESULT

• 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 and Prevention, National Center.

  RESULT

• 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

  RESULT

• Atlas, T. T. (2019). WHO report on the global tobacco epidemic, 2017. Tobacco Atlas. Retrieved from https://tobaccoatlas.org/topic/youth/

  RESULT

• 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.

  PMID: 10946439 RESULT

MeSH Terms

Conditions

Smoking Reduction; Smoking Cessation; Tobacco Smoking; Smoking

Interventions

School Nursing

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

School Health Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Divine D Logo, MPhil

CONTACT

+233240015215; divine.logo@ghsmail.org

Ellis Owusu-Dabo, Prof.

CONTACT

+233201964425; owusudabo@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: At the time of recruitment, all school administrations, parents, and students will be blinded to the group assignments, i.e., whether the school belonged to the intervention or the control group. A survey at the end of the intervention in the 3rd month will be conducted by an external individual who will be blinded to school allocation. The data analysis will be performed by a researcher from the team who will also be blinded to allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A two-arm parallel assignments to either an intervention or control from randomly selected schools

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 19, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share