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Efficacy of a Mobile Application in the Smoking Cessation Among Young People (TOBB_STOP)

This study is not yet open for participant recruitment.
Verified November 2012 by Jordi Gol i Gurina Foundation
Sponsor:
Collaborator:
Preventive Services and Health Promotion Research Network
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01734421
First received: November 22, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
 Other: Control group
Device: Cell phone Aplication for Smarth Phone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Smoking cessation [ Time Frame: Change in smoking status from baseline at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 604
Study Start Date: January 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control group
Habitual deshabituation in the control group following the guidelines of the primary health care institution.
 Other: Control group
6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation
Active Comparator: Cell phone Aplication for Smarth Phone
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • To have other addictions
  • Participants with Blackberry smarthphone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734421

Contacts
Contact: Empar Valdivieso López, Nurse +34675783477 evaldivieso.tarte.ics@gencat.cat
Contact: Gemma Flores Mateo, PhD +34626136232 gflores@idiapjgol.org

Locations
Spain
Jordi Gol i Gurina Foundation Not yet recruiting
Barcelona, Spain, 08007
Contact: Gemma Flores Mateo, PhD     +34626136232     gflores@idiapjgol.org    
Principal Investigator: Empar Valdivieso López, Nurse            
Sub-Investigator: Araceli Valverde Trillo, MD            
Sub-Investigator: Gemma Flores Mateo, PhD            
Sub-Investigator: Cristina Rey Reñones, Nurse            
Sub-Investigator: Juan Domingo Molina Gomez, Bsc            
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network
  More Information

No publications provided

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01734421     History of Changes
Other Study ID Numbers: PI12/01977
Study First Received: November 22, 2012
Last Updated: November 26, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:
Smoking cessation
Primary health care
Young people
Cellular phone

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on May 22, 2013