Condition category
Mental and Behavioural Disorders
Date applied
16/10/2014
Date assigned
04/11/2014
Last edited
24/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Smoking tobacco is a significant cause of death and illness. It can result in, among other things, a variety of cancers, stroke, heart disease and lung conditions such as emphysema. Nearly 100,000 young people start smoking worldwide. For every death related to smoking, more than 20 other people will suffer from at least one serious smoking-related illness. Smoking is still the most important underlying factor for preventable illness and death in Sweden. Identifying ways (interventions) to help young people to quit smoking would have a major impact on population health. Although primary healthcare services do offer proven interventions to stop people from smoking, they may not be really suitable or acceptable to younger people. Here, we want to test out a new quit smoking intervention aimed at getting young people to stop smoking. The program is called NEXit, “Nicotine exit”. It is a 12-week program based upon fully automated short mobile phone text messages. The messages are built from key elements of existing effective interventions as well as from officially recommended practice manuals and other literature and guidance from experts.

Who can participate?
Young people studying at colleges and universities in Sweden who smoke on a daily or weekly basis, who are willing to set a date to stop smoking within a 4-week period.

What does the study involve?
All participants are asked to choose a day to stop smoking (quit day). They are then randomly allocated into one of two groups. Those in group 1 receive motivational messages (the intervention) five times a day for three days before their stated quit day and then continue to receive 3-5 motivational text messages per day for week 1, 2-4 messages per day for the next 2-4 weeks, and then 10 messages per week for the remaining 8 weeks. Those participants in group 2 do not immediately receive the intervention. Instead, they have to wait until group 1 have completed the program before being able to access it themselves. We then assess the success of the program by looking at how many participants from either group have stopped smoking, compare the number of attempts made to stop smoking and, in cases where the participants are still smoking, compare the number of cigarettes smoked on a daily basis after the trial has finished.

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

Where is the study run from?
Linköping University (Sweden)

When is the study starting and how long is it expected to run for?
October 2014 to April 2015

Who is funding this study?
The Swedish Research Council (Sweden)

Who is the main contact?
Ulrika Müssener
ulrika.mussener@liu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Preben Bendtsen

ORCID ID

Contact details

Linköpings University IMH/SAM
Linköping
SE-581 83
Sweden
+46 (0) 702324615
preben.bendtsen@liu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1

Study information

Scientific title

SMS-based smoking cessation intervention among university students -– the NEXit trial: a two-arm randomized controlled trial from Sweden

Acronym

NEXit

Study hypothesis

The study aims to evaluate the effectiveness of a SMS based quit smoking application, employing a randomized controlled trial (RCT) design with an intervention group (group 1) and a waiting list control condition (group 2) that first will have access to the intervention after a 4 months follow-up. Four main hypotheses have been outlined:
1. Proportion of participants reporting prolonged abstinence or 4-weeks/7-days point prevalence of abstinence will differ in group 1 and 2, with group 1 having a higher proportion of participants having quitting smoking measured immediately after the end of the 12 week intervention
2. Quit attempts will differ, with group 1 having more quit attempts compared to group 2 measured since the time of randomization (19 weeks)
3. Utilisation of other smoking cessation services will differ with group 1 having used more other smoking cessation services since the time of randomization (19 weeks)
4. The number of daily smoked cigarettes at the time of follow-up will be lower in group 1 among those who still smoke at the time of follow-up.

Ethics approval

The Regional Ethics Committee in Linköping, 17/06/2014, ref Dnr: 2014/217-31

Study design

Two-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.nexit.nu (in Swedish only)

Condition

Tobacco smoking

Intervention

After randomisation and signing on, the intervention starts with a motivational phase of between one to four weeks depending on when the participants set a quit date. The participants are given an opportunity to set a quit date every week during this 4 weeks motivational phase. If no active quit date is set with this 4 week period the participant is given a quit date immediately after the 4 week motivational phase in accordance with the inclusion criteria and informed consent.

In this first motivational phase the participants receive 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.

Before the quit day the participants will receive dedicated messages five times a day during three days immediately before the quit date in order to prepare the smokers for quitting smoking. These messages will prompt participants to get rid of cigarettes, ashtrays and lighters and to avoid environments where they could normally smoke, and encouraged to overcome challenges of quitting

After setting a quit date the core intervention runs for twelve weeks. The participants will receive 3-5 text messages per day for the first week, 2-4 messages the next 2-4 weeks, and then 10 text messages per week the following eight weeks. Messages will encourage participants to persevere with the quite attempt and focused on their success so far. They will be prepared with coping messages for handling cravings, motivational messages, encouragement to preserve with the quit attempt, and assistance with withdrawal symptoms.

The intervention includes a function where the participants could ask for more SMS when having problems with craving, relapse or weight gain. By texting the word “crave” participants with cigarette cravings received instant messages to distract or support them during these episodes. By texting the word “lapse”, participants received a series of text messages that encourage them to continue with their quit attempt. By texting “weight”, participants received tips on how to avoid weight gain.

Follow up will be performed immediately after the end of the 12-week intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Self-reported prolonged abstinence (defined as having not smoked more than 5 cigarettes the last 8 weeks)
2. Self-reported 4 weeks point prevalence of smoking abstinence (not having smoked a single cigarette).

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 since the first invitation to the study (19 weeks)
3. Use of other smoking cessation services (medication, counselling, calling help line etc.), since the first invitation to the study (19 weeks).
4. Number of daily smoked cigarettes at the time of follow-up among those who still smokes at the time of follow-up.

Overall trial start date

20/10/2014

Overall trial end date

19/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All students (age range approx 18-30) that are daily or weekly smokers and willing to set a quit date for stop smoking within a 4 weeks period. There is no restriction on the use of other smoking cessation treatments or methods.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

To achieve a power of 80% with a significance level of 0.05 (two-sided), each group needs 474 people. If 30% attrition in the follow-up measurement, each group needs 677

Participant exclusion criteria

Non-smokers/occasional smokers not smoking every week and smokers not willing to set a stop date within 4 weeks after informed consent to participate.

Recruitment start date

20/10/2014

Recruitment end date

19/04/2015

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköpings University IMH/SAM
Linköping
SE-581 83
Sweden

Sponsor information

Organisation

The Swedish Research Council (Sweden)

Sponsor details

Box 1035
Stockholm
SE-101 38
Sweden
+46 (0) 854644000
vetenskapsradet@vr.se

Sponsor type

Research council

Website

Funders

Funder type

Research council

Funder name

The Swedish Research Council (Sweden), Box 1035, SE-101 38 Stockholm, Sweden, +46 (0)8 54644000

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

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25872503
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26903176

Publication citations

Additional files

Editorial Notes

24/02/2016: Publication reference added.