NCT03448900

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

8 months

First QC Date

February 20, 2018

Last Update Submit

February 28, 2018

Conditions

Keywords

CessationCollege studentMotivational InterviewSelf-efficacyIntentionBeliefsYoung adult

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

EXPERIMENTAL

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

Brief advice

ACTIVE COMPARATOR

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

Interventions

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

Multicomponent intervention
Brief adviceBEHAVIORAL

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

Brief advice

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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.

  • 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.

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Miren I Pardavila-Belio, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

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

Locations