SmokingNCT03448900
Intervention Study for Smoking Cessation in Spanish College Students
A study testing Multicomponent intervention and Brief advice in people with Smoking and Smoking Cessation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Multicomponent intervention and Brief advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months
Who cannot join
- Students who are ex-smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Multicomponent intervention, Brief advice
- Keywords
- Cessation, College student, Motivational Interview, Self-efficacy, Intention, Beliefs, Young adult
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent interventionBehavioural
Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes)
Brief adviceBehavioural
Brief advice (5-10minutes) and a self-help pamphlet
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Brief advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
The difference in the proportion of students who stopped smoking, between intervention and control subjects.
Measured: 6 month follow-up
Secondary outcomes (6)
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
Measured: 6 month follow-up
Quit attempts
Among students that continued smoking the difference in the numbers of quit attempts between intervention and control subjects
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startSep 2013
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Navarra
- Responsible party
- Sponsor
- Investigators
- Miren I Pardavila-Belio, PhD, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448900
- Sponsor's protocol ID
- Smoking
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 26053958Pardavila-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.
PubMed 30590861
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study for Smoking Cessation in Spanish College Students: Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03448900
- Acronym / sponsor ID
- Smoking
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Cessation, College student, Motivational Interview, Self-efficacy, Intention, Beliefs, Young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- University of Navarra
- Study start
- Sep 2013 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluate the effectiveness of a nurse multi-component intervention aimed at helping Spanish college student smokers to quit smoking.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent intervention | Experimental | Behavioral: Multicomponent interventionThe 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 comparator | Behavioral: Brief adviceThe 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Undergraduate or master students that smoked an average of at least one cigarette a week within the last 6 months
Key exclusion criteria (1 listed)
- Students who are ex-smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent interventionMotivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes) | Behavioural | Multicomponent intervention |
| Brief adviceBrief advice (5-10minutes) and a self-help pamphlet | Behavioural | Brief advice |
Primary outcome
Smoking cessation
Time frame: 6 month follow-up
The difference in the proportion of students who stopped smoking, between intervention and control subjects.
6 secondary outcomes
Mean of smoked cigaretes
Time frame: 6 month follow-up
Quit attempts
Time frame: 6 month follow-up
Stages of change according to Prochaska's model
Time frame: 6 month follow-up
The self-efficacy to avoid smoking, and
Time frame: 6 month follow-up
Smoking-related beliefs
Time frame: 6 month follow-up
Intention to quit smoking
Time frame: 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Results publication: PubMed 26053958Pardavila-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.
- Results publication: PubMed 30590861Pardavila-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miren I Pardavila-Belio, PhD principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention and Brief advice in people with Smoking and Smoking Cessation, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448900, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.