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Completed

NCT Number: NCT03448900

Intervention Study for Smoking Cessation in Spanish College Students

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

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miren Idoia Pardavila Belio

Pamplona, Navarre, 31009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multicomponent intervention

Behavioral

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

Brief Advice

Behavioral

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

Primary outcomes

  1. Smoking cessation

    Time frame: 6 month follow-up

    The difference in the proportion of students who stopped smoking, between intervention and control subjects.

Secondary outcomes

  1. Mean of smoked cigaretes

    Time frame: 6 month follow-up

    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

  2. Quit attempts

    Time frame: 6 month follow-up

    Among students that continued smoking the difference in the numbers of quit attempts between intervention and control subjects

  3. Stages of change according to Prochaska's model

    Time frame: 6 month follow-up

    The difference in the distribution on the stages of change between intervention and control subjects at 6 month follow-up

  4. The self-efficacy to avoid smoking, and

    Time frame: 6 month follow-up

    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.

  5. Smoking-related beliefs

    Time frame: 6 month follow-up

    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. Intention to quit smoking

    Time frame: 6 month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • University of Navarra

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 28, 2018
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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