Smoking cessation intervention among university students in Sweden. A study of the effectiveness of a text messaging (short message service [SMS]) based stop smoking application

ISRCTN	ISRCTN96350682
DOI	https://doi.org/10.1186/ISRCTN96350682
Protocol serial number	1
Sponsor	Swedish Research Council (Sweden)
Funder	Swedish Research Council (Sweden), grant number 2012-39665-92722-49

Submission date: 12/02/2014
Registration date: 27/03/2014
Last edited: 23/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Smoking is responsible for more than 60 diseases and globally is the most important preventable cause of ill health and death. So far most public health smoking efforts targeted at young people have been focused on prevention of initiation of smoking, whereas smoking cessation programmes have been targeted at the adult population. There are not many proven effective smoking cessation interventions targeting young people.
The stop-smoking-program NEXit, Nicotine exit, is an 8-12 week smoking cessation intervention based on phone text messages (SMS). The messages incorporate elements from initiatives that have worked, official manuals on smoking cessation, other literature and guidance from smoking cessation experts.

Who can participate?
Eligible participants are all students that are daily or occasional smokers.

What does the study involve?
The students will receive invitation to participate in the study by e-mail. Students who are daily or occasional smokers and who consent to participate are then randomly allocated to an intervention group which will have access to the stop-smoking-program immediately or to a control group that will have access to the intervention after 15 weeks (after follow-up for research purposes).

What are the possible benefits and risks of participating?
The possible benefits are support to stop smoking. There are no known side effects.

Where is the study run from?
The study is carried out by researchers at Linköping University, Sweden, using students from one university, Luleå Technical University in the northern part of Sweden.

When is the study starting and how long is it expected to run for?
The study will start in January 2014 and will end in June 2014.

Who is funding the study?
The study is funded by The Swedish Research Council.

Who is the main contact?
Professor Preben Bendtsen
preben.bendtsen@liu.se

Contact information

Prof Preben Bendtsen
Scientific

Institutionen för Medicin och Hälsa
Linköpings Universitet
Linköping
S-581 83
Sweden

Phone	+46 (0) 7 023 24 615
Email	preben.bendtsen@liu.se

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effectiveness of a text messaging (SMS) smoking cessation intervention among university students in Sweden: a pilot randomized controlled trial
Study acronym	NEXit (Nicotine EXit) 2.0 study
Study objectives	The study aims to develop a SMS-based stop smoking application, and to undertake a pilot randomized controlled trial (RCT) study to prepare for the evaluation of the effectiveness of such a program in a future main trial. The pilot trial is undertaken with smokers who are students at the University of Luleå in Sweden. The study will randomise smokers willing to participate to an intervention group or a waiting list group that will have access to the intervention after 15 weeks. The primary hypothesis is that a greater proportion of the intervention group will have stopped smoking during the follow-up time than the waiting list group.
Ethics approval(s)	Ethics Committee in Linköping, 04/03/2013, ref: 2013/406-31.
Health condition(s) or problem(s) studied	Tobacco smoking
Intervention	After randomisation and signing on, the intervention starts with a motivational phase of between 1 to 4 weeks, when the participants are given the opportunity to set a quit date. In this first phase the participants receive two SMS of motivating messages with information relevant for quitting, i.e. symptoms to expect on quitting, in other words biofeedback messages about what happens in the body after a quit attempt, tips to avoid weight gain, tips to cope with cravings, avoiding smoking triggers, motivational support, and how to distract ones mind from smoking. Once a week during this first phase the participants will be asked if they are ready to decide a quit date, and if doing so then pass into a second phase with dedicated messages five times a day during the three days immediately before the quit date in order to prepare the smokers for quitting smoking. The quit dates are to be set within 1-4 weeks after having signed up. After setting a quit date the core interventions run for 8 weeks. The participants are able to restart the intervention and discontinue the intervention at any time.
Intervention type	Other
Primary outcome measure(s)	1. Self-reported prolonged smoking abstinence of 8 weeks (defined as having not smoked more than five cigarettes) 2. Self-reported point prevalence of smoking abstinence (not having smoked a single cigarette) in the previous 4 weeks
Key secondary outcome measure(s)	1. Self-reported 7-days point prevalence smoking abstinence (defined as not smoking any cigarettes in the past 7 days) 2. Number of quit attempts during the 15 weeks after the invitation to participate 3. Use of other smoking cessation services (medication, counselling, calling help line etc) during the 15 weeks after the invitation to participate
Completion date	15/06/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	8000
Key inclusion criteria	All students who are daily or occasional smokers at Luleå University will be invited to participate via an e-mail, aged 18-65
Key exclusion criteria	Non-smokers
Date of first enrolment	20/01/2014
Date of final enrolment	15/06/2014

Locations

Countries of recruitment

Sweden

Study participating centre

Institutionen för Medicin och Hälsa

Linköping
S-581 83
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016	23/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

23/01/2019: Publication reference added