School-based waterpipe smoking cessation intervention program among Jordanian adolescents
| ISRCTN | ISRCTN85092033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85092033 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/07/2015
- Registration date
- 11/08/2015
- Last edited
- 10/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Recent studies showed that the popularity of tobacco smoking, particularly waterpipe, is high among Jordanian school students, but no school-based interventions to discourage waterpipe smoking have been tested. This study aims to test the effectiveness of a behavioral counseling waterpipe smoking cessation program using the 5As guidelines directed toward waterpipe-smoking Jordanian school students.
Who can participate?
Students enrolled in grade 9, 10, 11, or 12 who report smoking at least one puff of waterpipe in the last 30 days.
What does the study involve?
Eight schools from Zarqa Governorate First Educational District will be recruited to participate in the study and will be randomly allocated to deliver either a school-based counseling intervention or to hand out informational pamphlets regarding smoking cessation. Students will be assessed at the start of the study and 1, 3 and 6 months later to assess the short- and long-term effects of the intervention.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Zarqa Governorate First Educational District schools (Jordan).
When is the study starting and how long is it expected to run for?
March 2015 to April 2016.
Who is funding the study?
American University of Beirut (Lebanon).
Who is the main contact?
Dr Sukaina Alzyoud
Contact information
Public
Faculty of Nursing
Hashemite University
P.O. Box 330127
Zrqa
13115
Jordan
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Prevention |
| Scientific title | School-based waterpipe smoking cessation intervention program among Jordanian adolescents: a randomized controlled trial |
| Study objectives | To demonstrate a significantly 2.63, 2.99 and 4.01% increase in waterpipe smoking abstinence rates, defined as the percentage reporting no waterpipe smoking in the last 30 days, among students in the intervention compared to control schools at 1-, 3-, and 6-months follow-up assessments. |
| Ethics approval(s) | Institutional Review Board - The Hashemite University, 26/03/2015 |
| Health condition(s) or problem(s) studied | Waterpipe smoking among youth |
| Intervention | Study intervention Includes two arms: School-Based Counseling Intervention (CI) The CI is based on the 5As intervention model, it is based on the Social Cognitive Theory [SCT] which incorporates cognitive-behavioral principles and posits that behavior and behavior change involve the following: 1. Knowledge of the risks and benefits of a behavior 2. Outcome expectations, that is expectations about positive and negative outcomes anticipated for the behavior, which are learned from prior experience, observing others, hearing about similar situations from others, and emotional or physical responses to the behavior 3. Self-control, or the ability to engage in goal-directed behavior including goal-setting, self-monitoring, problem-solving and self-reward 4. Behavioral capability, the knowledge and skills necessary to perform the given behavior to meet goals established, including addressing barriers to successfully engaging in the behavior 5. Self-efficacy, confidence in one’s ability to successfully perform the behavior, including confidence in overcoming anticipated barriers. Description of the Information Only (IO) Students in the IO schools will have four weekly visits with the school counselor over the course of a month (equivalent to the CI condition). During these visits the school counselor will deliver a series of informational pamphlets regarding smoking and cessation (4 total) that was developed by the Jordanian Ministry of Health, check waterpipe smoking status and efforts at quitting, and ask if the student has any questions. |
| Intervention type | Behavioural |
| Primary outcome measure | Variables will be measured using questionnaires: 1. Waterpipe smoking in last 30 days: measured at baseline and 1-, 3- and 6-months follow-up 2. Waterpipe smoking in last 48 hours: measured at baseline and 1-, 3- and 6-months follow-up 3. Waterpipe smoking in last 24 hours : measured at baseline and 1-, 3- and 6-months follow-up 4. # of waterpipe smoking in last 30 days: measured at baseline and 1-, 3- and 6-months follow-up 5. Frequency of waterpipe smoking in last 30 days: measured at baseline and 1-, 3- and 6-months follow-up 6. Awareness of smoking health risks: measured at baseline and 1-, 3- and 6-months follow-up 7. Quit attempts: measured at baseline and 1-, 3- and 6-months follow-up |
| Secondary outcome measures | Cotinine assessment using cotinine saliva testing will be measured at baseline and 1-, 3- and 6-months follow-up |
| Overall study start date | 01/03/2015 |
| Completion date | 30/04/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Around 240 |
| Key inclusion criteria | 1. Enrolled in grade 9, 10, 11, or 12 at the time of study enrollment 2. Reporting smoking at least one puff of waterpipe in the last 30 days 3. Reporting willingness to participate in a smoking cessation intervention study 4. Able to complete the baseline questionnaire independently, indicating ability to complete study assessments and protocols 5. Intending to remain enrolled in the school for the remainder of the school year 6. Willing to provide contact information for the next 6 months |
| Key exclusion criteria | None waterpipe smokers |
| Date of first enrolment | 25/08/2015 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- Jordan
Study participating centre
Jordan
Sponsor information
University/education
P.O. Box 11-0236
Beirut
1107 2020
Lebanon
"ROR" |
https://ror.org/04pznsd21 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | |
| IPD sharing plan |
