Condition category
Mental and Behavioural Disorders
Date applied
12/02/2014
Date assigned
27/03/2014
Last edited
27/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

http://www.nexit.nu

Contact information

Type

Scientific

Primary contact

Prof Preben Bendtsen

ORCID ID

Contact details

Institutionen för Medicin och Hälsa
Linköpings Universitet
Linköping
S-581 83
Sweden
+46 (0) 7 023 24 615
preben.bendtsen@liu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Effectiveness of a text messaging (SMS) smoking cessation intervention among university students in Sweden: a pilot randomized controlled trial

Acronym

NEXit (Nicotine EXit) 2.0 study

Study hypothesis

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

Ethics Committee in Linköping, 04/03/2013, ref: 2013/406-31.

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

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 one’s 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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

20/01/2014

Overall trial end date

15/06/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8000

Participant exclusion criteria

Non-smokers

Recruitment start date

20/01/2014

Recruitment end date

15/06/2014

Locations

Countries of recruitment

Sweden

Trial participating centre

Institutionen för Medicin och Hälsa
Linköping
S-581 83
Sweden

Sponsor information

Organisation

Swedish Research Council (Sweden)

Sponsor details

Box 1035
Stockholm
S-10138
Sweden
+46 (0) 8 546 44 000
vetenskapsradet@vr.se

Sponsor type

Research council

Website

http://www.vr.se/

Funders

Funder type

Research council

Funder name

Swedish Research Council (Sweden), grant number 2012-39665-92722-49

Alternative name(s)

Swedish Research Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

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

Publication citations

Additional files

Editorial Notes