Intervention Study for Smoking Cessation in Spanish College Students
1 other identifier
interventional
255
1 country
1
Brief Summary
This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 20, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedMarch 1, 2018
February 1, 2018
8 months
February 20, 2018
February 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking cessation
The difference in the proportion of students who stopped smoking, between intervention and control subjects.
6 month follow-up
Secondary Outcomes (6)
Mean of smoked cigaretes
6 month follow-up
Quit attempts
6 month follow-up
Stages of change according to Prochaska's model
6 month follow-up
The self-efficacy to avoid smoking, and
6 month follow-up
Smoking-related beliefs
6 month follow-up
- +1 more secondary outcomes
Study Arms (2)
Multicomponent intervention
EXPERIMENTALThe 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).
Brief advice
ACTIVE COMPARATORThe 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.
Interventions
Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes)
Eligibility Criteria
You may qualify if:
- \- Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months
You may not qualify if:
- \- Students who are ex-smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miren Idoia Pardavila Belio
Pamplona, Navarre, 31009, Spain
Related Publications (2)
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.
PMID: 26053958RESULTPardavila-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.
PMID: 30590861RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miren I Pardavila-Belio, PhD
University of Navarra
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Randomization was performed by one member of the research team who generated a blocked random number sequence, using EpiInfo version 7.0.9.7, and prepared the sealed opaque sequentially numbered envelopes (1-255) with the corresponding condition written inside. After each student agreed to participate in the study, the enve- lope was opened, determining the group to which he or she would be assigned. Students were unaware of the group assignments and randomization scheme.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2018
First Posted
February 28, 2018
Study Start
September 1, 2013
Primary Completion
May 1, 2014
Study Completion
October 1, 2014
Last Updated
March 1, 2018
Record last verified: 2018-02