Intervention Study for Smoking Cessation in Spanish College Students

Smoking Cessation Clinical Trial

Official title:

Intervention Study for Smoking Cessation in Spanish College Students: Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448900
• Other study ID #: Smoking
• 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
• 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

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

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