Condition category
Mental and Behavioural Disorders
Date applied
27/08/2014
Date assigned
08/09/2014
Last edited
06/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Smoking is very common among adolescents with lower educational levels. This is a serious public health problem. A previous study tested the appropriateness and effectiveness of a fully automated text messaging-based intervention for smoking cessation (quitting smoking) in young people. It showed that this intervention could reach a high proportion of smoking vocational school students and reduce their cigarette consumption. However, it did not keep them from smoking for long. Problem drinking, particularly binge drinking, is very common in adolescent and young adult smokers and relapses after successful smoking cessation are often associated with alcohol consumption. Therefore, a combination of an integrated smoking cessation and binge drinking intervention is expected to be more effective than a smoking cessation only intervention. The aim of this study is to test the effectiveness of an internet and mobile phone-based integrated smoking cessation and binge drinking intervention compared with a smoking cessation only intervention.

Who can participate?
Daily and occasionally smoking vocational school students in the German-speaking part of Switzerland aged 16 and older who own a mobile phone.

What does the study involve?
Study participants are randomly allocated to one of two groups. Participants of both groups initially participate in a survey about their tobacco smoking and drinking behaviour. Participants in group 1 then receive the integrated smoking cessation and binge drinking intervention. They will get customised web-based feedback on their drinking behaviour, mobile phone text messages to encourage drinking within low-risk limits over a time period of 3 months, mobile phone text messages to support smoking cessation over a period of 3 months, and have a chance to register for a more intensive program providing strategies for smoking cessation around a self-defined quit date. Participants in group 2 will receive a smoking cessation only intervention including customised mobile phone text messages to support smoking cessation over a time period of 3 months and a chance to register for a more intensive program providing strategies for smoking cessation around a self-defined quit date. Participants are then followed up 6 months after the initial survey.

What are the possible benefits and risks of participating?
We expect that the participants who received the integrated intervention will smoke less than the participants who receive the smoking cessation only intervention. There are no risks.

Where is the study run from?
Swiss Research Institute for Public Health and Addiction (Switzerland).

When is the study starting and how long is it expected to run for?
September 2014 to December 2016

Who is funding the study?
Swiss Tobacco Prevention Fund (Switzerland).

Who is the main contact?
Dr Severin Haug
severin.haug@isgf.uzh.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Severin Haug

ORCID ID

Contact details

Konradstrasse 32
Zurich
8031
Switzerland
severin.haug@isgf.uzh.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of an Internet and mobile phone-based integrated smoking cessation and binge drinking intervention compared to a smoking cessation only intervention for smoking cessation in young people: a two-arm cluster randomised controlled trial

Acronym

Study hypothesis

The main objective of the planned study is to test the efficacy of an integrated smoking cessation and binge drinking intervention compared to a smoking cessation only intervention for smoking cessation in young people. Our main hypothesis is that the integrated intervention will be more effective than the smoking cessation only intervention for reducing cigarette consumption and achieving smoking abstinence.

Ethics approval

Ethics committee of the Philosophical Faculty of the University of Zurich, Switzerland, 13/08/2014

Study design

Two-arm cluster-randomized single blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Tobacco smoking

Intervention

Integrated smoking cessation and binge drinking intervention
1. Individually tailored mobile phone text messages to support smoking cessation and addressing (a) the risks of smoking, (b) the monetary costs of smoking, (c) the social norms of smoking, (d) outcome expectancies, (e) motivation to reduce cigarette consumption, (f) motivation to use social support for smoking cessation, (g) strategies to cope with craving situations, (h) tips for preparing for smoking cessation, (i) reward for staying abstinent. Participants will receive two weekly text messages over a time period of 3 months.
2. Possibility to register for a more intensive program providing strategies for smoking cessation around a self-defined quit date. Participants will receive one or two text messages per day for a period of 4 weeks.
3. Web-based feedback including individually tailored information on (a) the number of drinks consumed per week in relation to the age- and gender-specific reference group, (b) financial costs of drinking, (c) calories consumed with alcoholic drinks, and (d) number of binge drinking occasions in relation to the age- and gender-specific reference group.
The participants will receive a single web-based feedback immediately after the baseline assessment.
4. Individually tailored mobile phone text messages to stimulate drinking within low-risk limits. Only participants with binge drinking (five or more drinks on one occasion in the last 30 days for male and four or more drinks on one occasion in the last 30 days for female participants) at the baseline assessment will receive these messages (one message per week) over a time period of 3 months.


Smoking cessation only intervention
1. Individually tailored mobile phone text messages to support smoking cessation and addressing (a) the risks of smoking, (b) the monetary costs of smoking, (c) the social norms of smoking, (d) outcome expectancies, (e) motivation to reduce cigarette consumption, (f) motivation to use social support for smoking cessation, (g) strategies to cope with craving situations, (h) tips for preparing for smoking cessation, (i) reward for staying abstinent. Participants will receive two weekly text messages over a time period of 3 months.
2. Possibility to register for a more intensive program providing strategies for smoking cessation around a self-defined quit date. Participants will receive one or two text messages per day for a period of 4 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. 7-day point prevalence smoking abstinence (i.e., not having smoked a puff within the past 7 days) assessed at 6-month follow up
2. Cigarette consumption assessed at 6-month follow up (number of cigarettes smoked on a typical day for daily smokers, typical number of smoking days per month and number of cigarettes smoked on a typical smoking day for occasional smokers)

Secondary outcome measures

1. 30-day point prevalence smoking abstinence (i.e., not having smoked a puff within the past 30 days) assessed at 6-month follow up
2. Stage of change according to the Health Action Process Approach (Schwarzer et al. 2008, Applied Psychology) assessed at 6-month follow up
3. Quit attempt within the previous 6 months assessed at 6-month follow up
4. Alcohol consumption assessed at 6-months follow up by a 7-day drinking calendar for which participants are asked to think about a typical week in the past month and, for each day, to record the number of standard drinks they typically consume on that day.

Overall trial start date

01/09/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Daily cigarette smoking or occasional cigarette smoking (at least four cigarettes in the previous month and at least one cigarette in the previous week)
2. Aged above 15 years
3. Possession of a mobile phone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

675 per study group resulting in a total of n=1350 study participants

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Switzerland

Trial participating centre

Konradstrasse 32
Zurich
8031
Switzerland

Sponsor information

Organisation

Swiss Research Institute for Public Health and Addiction (Switzerland)

Sponsor details

c/o Severin Haug
Konradstrasse 32
Zurich
8031
Switzerland
severin.haug@isgf.uzh.ch

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Swiss Tobacco Prevention Fund (Switzerland) (Ref. No. 13.006402)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25369857

Publication citations

  1. Protocol

    Haug S, Paz Castro R, Filler A, Kowatsch T, Fleisch E, Schaub MP, Efficacy of an internet and SMS-based integrated smoking cessation and alcohol intervention for smoking cessation in young people: study protocol of a two-arm cluster randomised controlled trial., BMC Public Health, 2014, 14, 1140, doi: 10.1186/1471-2458-14-1140.

Additional files

Editorial Notes