Condition category
Not Applicable
Date applied
27/07/2015
Date assigned
11/08/2015
Last edited
10/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Sukaina Alzyoud

ORCID ID

Contact details

Faculty of Nursing
Hashemite University
P.O. Box 330127
Zrqa
13115
Jordan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

School-based waterpipe smoking cessation intervention program among Jordanian adolescents: a randomized controlled trial

Acronym

Study hypothesis

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

Institutional Review Board - The Hashemite University, 26/03/2015

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2015

Overall trial end date

30/04/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

Around 240

Participant exclusion criteria

None waterpipe smokers

Recruitment start date

25/08/2015

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Jordan

Trial participating centre

Zarqa Governorate First Educational District schools
13133
Jordan

Sponsor information

Organisation

American University of Beirut (Lebanon)

Sponsor details

P.O. Box 11-0236
Beirut
1107 2020
Lebanon

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

American University of Beirut (Lebanon)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes