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SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial).

Müssener U, Bendtsen M, Karlsson N, White IR, McCambridge J, Bendtsen P - Trials (2015)

Bottom Line: The study will examine the effectiveness of a stand-alone SMS text-based intervention.As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs.Protocol version: Version 1, and date 7 November 2014.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine and Health Sciences, Linköping University, 581 83, Linköping, Sweden. ulrika.mussener@liu.se.

ABSTRACT

Background: Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results.

Methods/design: The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention.

Discussion: The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary outcome and response is the same at every attempt.

Isrctn: ISRCTN75766527, dated assigned 4 November 2014. Protocol version: Version 1, and date 7 November 2014.

No MeSH data available.


Related in: MedlinePlus

Consolidated Standards of Reporting Trials (CONSORT) flow chart. CONSORT flow chart illustrating all steps in the study from enrolment to allocation and follows up. Inclusion and exclusion criteria are also specified as well as outcome measures.
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Fig1: Consolidated Standards of Reporting Trials (CONSORT) flow chart. CONSORT flow chart illustrating all steps in the study from enrolment to allocation and follows up. Inclusion and exclusion criteria are also specified as well as outcome measures.

Mentions: All 25 student health care centres responsible for preventive services for students in Sweden will participate in recruiting interested smokers during a 4-week period in October 2014, through advertisement at strategic places in each college and university. This includes leaflets, posters and information on the local website and in some cases the official Facebook account. Participants register their interest in taking part in the study by sending a SMS to a dedicated telephone number. Interested students will receive mail with more information about the study and how to participate. Also, 19 student health care centres will send an invitation by Email to all students at the end of October 2014 with 2 reminders with 1 week apart, allowing the participants to respond up to 7 days after the last reminder. This means that recruitment of participants will be finalised at the end of the second week of November 2014. A flowchart of the study recruitment procedure is given in Figure 1. Eligible participants are students who are daily or weekly smokers and willing to set a quit date for smoking cessation within the next 4-week period. Exclusion criteria are non-smokers/occasional smokers not smoking every week, and smokers not willing to set a quit date within 4 weeks.Figure 1


SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial).

Müssener U, Bendtsen M, Karlsson N, White IR, McCambridge J, Bendtsen P - Trials (2015)

Consolidated Standards of Reporting Trials (CONSORT) flow chart. CONSORT flow chart illustrating all steps in the study from enrolment to allocation and follows up. Inclusion and exclusion criteria are also specified as well as outcome measures.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4403894&req=5

Fig1: Consolidated Standards of Reporting Trials (CONSORT) flow chart. CONSORT flow chart illustrating all steps in the study from enrolment to allocation and follows up. Inclusion and exclusion criteria are also specified as well as outcome measures.
Mentions: All 25 student health care centres responsible for preventive services for students in Sweden will participate in recruiting interested smokers during a 4-week period in October 2014, through advertisement at strategic places in each college and university. This includes leaflets, posters and information on the local website and in some cases the official Facebook account. Participants register their interest in taking part in the study by sending a SMS to a dedicated telephone number. Interested students will receive mail with more information about the study and how to participate. Also, 19 student health care centres will send an invitation by Email to all students at the end of October 2014 with 2 reminders with 1 week apart, allowing the participants to respond up to 7 days after the last reminder. This means that recruitment of participants will be finalised at the end of the second week of November 2014. A flowchart of the study recruitment procedure is given in Figure 1. Eligible participants are students who are daily or weekly smokers and willing to set a quit date for smoking cessation within the next 4-week period. Exclusion criteria are non-smokers/occasional smokers not smoking every week, and smokers not willing to set a quit date within 4 weeks.Figure 1

Bottom Line: The study will examine the effectiveness of a stand-alone SMS text-based intervention.As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs.Protocol version: Version 1, and date 7 November 2014.

View Article: PubMed Central - PubMed

Affiliation: Department of Medicine and Health Sciences, Linköping University, 581 83, Linköping, Sweden. ulrika.mussener@liu.se.

ABSTRACT

Background: Most smoking efforts targeting young people have so far been focused on prevention of initiation, whereas smoking cessation interventions have largely been targeted towards adult populations. Thus, there is limited evidence for effective smoking cessation interventions in young people, even though many young people want to quit smoking. Mobile communication technology has the potential to reach large numbers of young people and recent text-based smoking cessation interventions using phones have shown promising results.

Methods/design: The study aims to evaluate a newly developed text-based smoking cessation intervention for students in colleges and universities in Sweden. The design is a randomised controlled trial (RCT) with a delayed/waiting list intervention control condition. The trial will be performed simultaneously in all colleges and universities served by 25 student health care centres in Sweden. Outcomes will be evaluated after 4 months, with 2 cessation primary outcomes and 4 secondary outcomes. After outcome evaluation the control group will be given access to the intervention.

Discussion: The study will examine the effectiveness of a stand-alone SMS text-based intervention. The intervention starts with a motivational phase in which the participants are given an opportunity to set a quit date within 4 weeks of randomisation. This first phase and the subsequent core intervention phase of 12 weeks are totally automated in order to easily integrate the intervention into the daily routines of student and other health care settings. As well as providing data for the effectiveness of the intervention, the study will also provide data for methodological analyses addressing a number issues commonly challenging in Internet-based RCTs. For example, an extensive follow-up strategy will be used in order to evaluate the use of repeated attempts in the analysis, and in particular to explore the validity of a possible missing not at random assumption that the odds ratio between the primary outcome and response is the same at every attempt.

Isrctn: ISRCTN75766527, dated assigned 4 November 2014. Protocol version: Version 1, and date 7 November 2014.

No MeSH data available.


Related in: MedlinePlus