NCT01734421

Brief Summary

AIM: To assess the efficacy of an intervention based on the specific design and implementation of a mobile application (APP) in order to reduce the prevalence of smoking consumption among young people motivated 18 to 30 years METHODS: Cluster randomised clinical trial. Unit of randomization: Primary Health Care Centers (PHCC). Intention to treat analysis. STUDY POPULATION: Motivated young smokers of 10 or more cigarettes per day aged 18 to 30 years consulting for any reason to PHCC and who provided written informed consent to participate in the trial. INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application. Control group: usual care. OUTCOME MEASURES: Abstinence at 12 months confirmed by exhaled air carbon monoxide concentration of less or iqual 10 parts per million in each control. RESULTS: The application of a smoking cessation intervention with a mobile APPs application will improve the smoking cessation success rate in smokers, besides of their intention or not to give up smoking at baseline.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
604

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

2.4 years

First QC Date

November 22, 2012

Last Update Submit

November 26, 2012

Conditions

Smoking Cessation

Keywords

Smoking cessationPrimary health careYoung peopleCellular phone

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    Change in smoking status from baseline at 6 months

Study Arms (2)

Control group

OTHER

Habitual deshabituation in the control group following the guidelines of the primary health care institution.

Other: Control group

Cell phone Aplication for Smarth Phone

ACTIVE COMPARATOR

Cell phone 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application

Device: Cell phone Aplication for Smarth Phone

Interventions

Control groupOTHER

6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation

Control group
Cell phone Aplication for Smarth PhoneDEVICE
Cell phone Aplication for Smarth Phone

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant between 18 t0 30 years old smoking 10 or more cigarretes at day
  • To have a smarthphone (Android, ios Ihpone, ios Ipad)
  • Normal and high motivation for smocking cessation

You may not qualify if:

  • To have other addictions
  • Participants with Blackberry smarthphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Gol i Gurina Foundation

Barcelona, 08007, Spain

Location

Related Publications (3)

  • Palleja-Millan M, Rey-Renones C, Barrera Uriarte ML, Granado-Font E, Basora J, Flores-Mateo G, Duch J. Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial. JMIR Mhealth Uhealth. 2020 Jun 26;8(6):e15951. doi: 10.2196/15951.

    PMID: 32589153DERIVED

  • Marin-Gomez FX, Garcia-Moreno Marchan R, Mayos-Fernandez A, Flores-Mateo G, Granado-Font E, Barrera Uriarte ML, Duch J, Rey-Renones C. Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial. JMIR Serious Games. 2019 Mar 27;7(1):e12835. doi: 10.2196/12835.

    PMID: 30916655DERIVED

  • Valdivieso-Lopez E, Flores-Mateo G, Molina-Gomez JD, Rey-Renones C, Barrera Uriarte ML, Duch J, Valverde A. Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial. BMC Public Health. 2013 Aug 1;13:704. doi: 10.1186/1471-2458-13-704.

    PMID: 23915067DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Empar Valdivieso López, Nurse

CONTACT

+34675783477evaldivieso.tarte.ics@gencat.cat

Gemma Flores Mateo, PhD

CONTACT

+34626136232gflores@idiapjgol.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 27, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

ES(1)