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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03448900
Other study ID # Smoking
Secondary ID
Status Completed
Phase N/A
First received February 20, 2018
Last updated February 28, 2018
Start date September 2013
Est. completion date October 2014

Study information

Verified date February 2018
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date October 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria

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

Exclusion Criteria

- Students who are ex-smokers

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multicomponent intervention
Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes)
Brief advice
Brief advice (5-10minutes) and a self-help pamphlet

Locations

Country Name City State
Spain Miren Idoia Pardavila Belio Pamplona Navarra

Sponsors (2)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra University of Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Pardavila-Belio MI, Canga-Armayor A, Duaso MJ, Pueyo-Garrigues S, Pueyo-Garrigues M, Canga-Armayor C. Understanding how a smoking cessation intervention changes beliefs, self-efficacy, and intention to quit: a secondary analysis of a pragmatic randomized

Pardavila-Belio MI, García-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking cessation The difference in the proportion of students who stopped smoking, between intervention and control subjects. 6 month follow-up
Secondary 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 6 month follow-up
Secondary Quit attempts Among students that continued smoking the difference in the numbers of quit attempts between intervention and control subjects 6 month follow-up
Secondary 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 6 month follow-up
Secondary 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. 6 month follow-up
Secondary 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. 6 month follow-up
Secondary 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. 6 month follow-up
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