Intervention Study for Smoking Cessation in Spanish College Students

NCT ID: NCT03448900

Last Updated: 2018-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Smoking Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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).

Group Type EXPERIMENTAL

Multicomponent intervention

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Brief advice

Intervention Type BEHAVIORAL

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

Interventions

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Multicomponent intervention

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

Intervention Type BEHAVIORAL

Brief advice

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Navarra

OTHER

Sponsor Role collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Miren I Pardavila-Belio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra

Locations

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Miren Idoia Pardavila Belio

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type RESULT
PMID: 26053958 (View on PubMed)

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.

Reference Type RESULT
PMID: 30590861 (View on PubMed)

Other Identifiers

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Smoking

Identifier Type: -

Identifier Source: org_study_id

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