Intervention Study for Smoking Cessation in Spanish College Students

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

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

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation
• Intervention / Treatment: Behavioral: Multicomponent intervention; Behavioral: Brief advice

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.

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31009
      • Miren Idoia Pardavila Belio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes)
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; Brief advice (5-10minutes) and a self-help pamphlet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation	The difference in the proportion of students who stopped smoking, between intervention and control subjects.	6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quit attempts	Among students that continued smoking the difference in the numbers of quit attempts between intervention and control subjects	6 month follow-up
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
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
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
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

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: University of Navarra
• Investigators: Principal Investigator: Miren I Pardavila-Belio, PhD, University of Navarra

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (ACTUAL): February 28, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Motivational Interview; Self-efficacy; Young adult; Cessation; Beliefs; Intention; College student
• Other Study ID Numbers: Smoking

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No