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A Mobile-phone Based Intervention to Support Smoking Cessation Among Chilean Women

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ClinicalTrials.gov Identifier: NCT03191019
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
The purpose of this study is to determine whether a mobile-phone based intervention is effective in supporting smoking cessation among Chilean women

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Mobile-phone app for smoking cessation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm, randomized clinical trial of a smoking cessation intervention based on a mobile-phone app. Participants will be randomly assigned to the intervention group or control group, in parallel for the duration of the study (6 months follow-up).
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Eligible participants will be randomized to the intervention group or control group using a computerized and automated process. An email will be automatically sent to the participants with the link to download the corresponding version of the mobile-phone app (intervention app or control app). Researchers who will gather data and those who will measure carbon monoxide in exhaled air will be masked to treatment allocation.
Primary Purpose: Treatment
Official Title: Design and Evaluation of a Mobile-phone Based Intervention to Support Smoking Cessation Among Chilean Women Aged 18 to 44 Years in the Metropolitan Region
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobile-phone app for smoking cessation
The intervention arm will receive a smoking cessation program based on a mobile-phone app. The program contains strategies to support smoking cessation, including motivational messages, tips on stress management, on how to ask support from friends and family, how to use distraction techniques and how to deal with cravings, lapses and early relapse. It also includes a saving calculator, a "help button" which provides extra messages in case of cravings and a "lapse button", which provides advice about what to do if the participant presents lapses or relapse after being abstinent at least 24 hours.
Behavioral: Mobile-phone app for smoking cessation
Android App for smoking cessation

Placebo Comparator: Control mobile-phone app
The control arm will receive a mobile-phone app which will send 1 message every two weeks thanking participants for taking part in the study, and encouraging them to stay in the study for the 6 month follow-up period.
Behavioral: Mobile-phone app for smoking cessation
Android App for smoking cessation




Primary Outcome Measures :
  1. Point prevalence of smoking abstinence at 4 weeks [ Time Frame: 4 weeks ]
    Self-reported no smoking in past 7 days at 4 weeks from quit date


Secondary Outcome Measures :
  1. Continuous smoking abstinence at 4 weeks [ Time Frame: 4 weeks ]
    Self-report of continuous abstinence (< 5 cigarettes) at 4 weeks

  2. Point prevalence of smoking abstinence at 3 months [ Time Frame: 3 months ]
    Self-reported no smoking in past 7 days at 3 months from quit date

  3. Continuous smoking abstinence at 3 months [ Time Frame: 3 months ]
    Self-report of continuous abstinence (< 5 cigarettes) at 3 months

  4. Point prevalence of smoking abstinence at 6 months [ Time Frame: 6 months ]
    Self-reported no smoking in past 7 days at 6 months from quit date

  5. Biochemically verified continuous smoking abstinence at 6 months [ Time Frame: 6 months ]
    Self-report of continuous abstinence (< 5 cigarettes) and passed carbon monoxide validation at 6 months

  6. Quit attempts [ Time Frame: 6 months ]
    Mean number of quit attempts since taking part in the study

  7. Use of other smoking cessation services [ Time Frame: 6 months ]
    Number of uses of other smoking cessation services since taking part in the study

  8. Number of cigarettes smoked per day or weekly at 6 months [ Time Frame: 6 months ]
    Mean number of cigarettes smoked per day or weekly among participants still smoking at 6 months

  9. Adverse events vehicle crashes [ Time Frame: 6 months ]
    Involvement in any vehicle crashes since taking part in the study

  10. Adverse events hand injury [ Time Frame: 6 months ]
    Repetitive strain injury of the hand related to use of mobile-phone since taking part in the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smoker of at least 1 cigarette per day or at least 7 cigarettes per week in the last 6 months
  • Willing to make a quit attempt in the next month
  • Owns and uses an Android cell phone
  • Lives in the Metropolitan Region and has no plans to move in the next year

Exclusion Criteria:

  • Severe mental disability or inability to read or answer a telephone survey
  • Screening positive for hazardous drinking behavior or active alcohol use disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191019


Contacts
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Contact: Carolina Lopez 56223543038 cxlopez@uc.cl
Contact: Javiera Martinez 56223548111 jmarting@med.puc.cl

Locations
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Chile
Centro de Salud Familiar Madre Teresa de Calcuta Recruiting
Santiago, Other (Non U.s.), Chile, 8190985
Contact: Juan Alcantara    56228515211    juanalcantaragomez@gmail.com   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Study Director: Claudia Bambs Pontificia Universidad Catolica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03191019     History of Changes
Other Study ID Numbers: 15-349
FONIS SA15I20120 ( Other Identifier: National Commission for Scientific & Technological Research )
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pontificia Universidad Catolica de Chile:
Cell phones
Women