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CompletedNCT03448900Updated Mar 1, 2018

Intervention Study for Smoking Cessation in Spanish College Students

An interventional study of Multicomponent intervention and Brief advice in Smoking and Smoking Cessation, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Completed at 1 site in Spain. Open to participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
01

Study summary

This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking.

Read the detailed description

This study hipotetize that a multicomponent intervention, tailored to college student and conducted by a nurse is more effective than brief advise.

The intervention was a multi-component intervention based on the Theory of Triadic Influence and on previous recommendations made in the Surgeon General's report . The strategies of this program consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The smoking-related Self-efficacy, Belief and Intention scale was used to assess outcomes.

02

Conditions studied

  • Smoking
  • Smoking Cessation

Keywords

  • Cessation
  • College student
  • Motivational Interview
  • Self-efficacy
  • Intention
  • Beliefs
  • Young adult
03

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months

Exclusion criteria

Exclusion Criteria

  • Students who are ex-smokers
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
255 participants (actual)

Study arms

  • Experimental
    Multicomponent intervention

    The intervention group consisted in face-to-face 50-minute meeting \[motivational interviewing (MI)\]; online self-help material focused on: (1) decisions; (2) moods; (3) social life; (4) smoking health effects; and (5) quitting; e-mail 15 days before the MI, group therapy 2 months after the MI (60 minutes), a second follow-up visit 4 months after the MI (20 minutes).

    Behavioral: Multicomponent intervention

  • Active comparator
    Brief advice

    The control group received a brief advice (5-10minutes) and a self-help pamphlet called 'Stop smoking'. Before giving brief advice, the nurse assessed smokers' habits and their willingness to quit. As is usually in this type of studies there were no follow-up sessions for this group.

    Behavioral: Brief advice

Interventions

  • BehavioralMulticomponent intervention

    Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes)

  • BehavioralBrief advice

    Brief advice (5-10minutes) and a self-help pamphlet

05

What researchers measure

Primary outcomes

  1. Smoking cessation

    The difference in the proportion of students who stopped smoking, between intervention and control subjects.

    Time frame: 6 month follow-up

Secondary outcomes

  1. Mean of smoked cigaretes

    Among students that continued smoking the difference in the mean of cigarrete per day between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program

    Time frame: 6 month follow-up

  2. Quit attempts

    Among students that continued smoking the difference in the numbers of quit attempts between intervention and control subjects

    Time frame: 6 month follow-up

  3. Stages of change according to Prochaska's model

    The difference in the distribution on the stages of change between intervention and control subjects at 6 month follow-up

    Time frame: 6 month follow-up

  4. The self-efficacy to avoid smoking, and

    the difference in the mean of self-efficacy to avoid smoking between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program; and the proportion of the total effect of smoking cessation explained by self-efficacy to avoid smoking.

    Time frame: 6 month follow-up

  5. Smoking-related beliefs

    the difference in the mean of smoking-related beliefs between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program; and the proportion of the total effect of smoking cessation explained by smoking-related beliefs.

    Time frame: 6 month follow-up

  6. Intention to quit smoking

    the difference in the mean of intention to quit smoking between intervention and control subjects; the difference in the mean of this variable pre- and post-intervention or control program; and the proportion of the total effect of smoking cessation explained by intention to stop smoking.

    Time frame: 6 month follow-up

06

Study locations

1 site
  • Miren Idoia Pardavila Belio
    Pamplona, Navarra 31009, Spain
07

References and documents

Publications

  • Pardavila-Belio MI, Garcia-Vivar C, Pimenta AM, Canga-Armayor A, Pueyo-Garrigues S, Canga-Armayor N. Intervention study for smoking cessation in Spanish college students: pragmatic randomized controlled trial. Addiction. 2015 Oct;110(10):1676-83. doi: 10.1111/add.13009. Epub 2015 Jul 2. PubMed 26053958 ↗
  • Pardavila-Belio MI, Canga-Armayor A, Duaso MJ, Pueyo-Garrigues S, Pueyo-Garrigues M, Canga-Armayor N. Understanding how a smoking cessation intervention changes beliefs, self-efficacy, and intention to quit: a secondary analysis of a pragmatic randomized controlled trial. Transl Behav Med. 2019 Jan 1;9(1):58-66. doi: 10.1093/tbm/ibx070. PubMed 30590861 ↗
08

Registry details

Key details

Study ID
NCT03448900
Lead sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
University of Navarra
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Sep 2013
Primary completion
May 2014
Completion
Oct 2014
Last update
Mar 1, 2018

Study contacts

Miren I Pardavila-Belio, PhD
principal investigator · University of Navarra

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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