Smoking CessationTOBB_STOPNCT01734421
Efficacy of a Mobile Application in the Smoking Cessation Among Young People
A study testing Cell phone Aplication for Smarth Phone in people with Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Cell phone Aplication for Smarth Phone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 604 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Dec 2015
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- To have other addictions
- Participants with Blackberry smarthphone
Trial locations and contacts
1 site in 1 country.
Spain1 site
Jordi Gol i Gurina Foundation
Barcelona, 08007
Gemma Flores Mateo, PhD, +34626136232, gflores@idiapjgol.org
Empar Valdivieso López, Nurse
About this study
Official title: Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial
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.
- Conditions
- Smoking Cessation
- Being tested
- Control group, Cell phone Aplication for Smarth Phone
- Keywords
- Smoking cessation, Primary health care, Young people, Cellular phone
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation
Cell phone Aplication for Smarth PhoneDevice
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Habitual deshabituation in the control group following the guidelines of the primary health care institution. Receives: 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 Receives: Device: Cell phone Aplication for Smarth Phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation
Measured: Change in smoking status from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies 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
- Outcomes assessor
- Enrolment
- 604 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734421
- Sponsor's protocol ID
- PI12/01977
- Acronym
- TOBB_STOP
- Status last verified
- Nov 2012
- First submitted
- 22 Nov 2012
- Last updated
- 27 Nov 2012
- Results posted
- No
Publications
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.
PubMed 32589153Marin-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.
PubMed 30916655Valdivieso-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.
PubMed 23915067
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacacy of a Mobile Application in the Smoking Cessation Among Young Poeple: Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01734421
- Acronym / sponsor ID
- TOBB_STOP / PI12/01977
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Primary health care, Young people, Cellular phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 604 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Nov 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Control groupHabitual deshabituation in the control group following the guidelines of the primary health care institution. |
| Cell phone Aplication for Smarth Phone | Active comparator | Device: Cell phone Aplication for Smarth PhoneCell phone 6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation which includes mobile APPs application |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- To have other addictions
- Participants with Blackberry smarthphone
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 |
|---|---|---|
| Control group6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation | Other | Control group |
| Cell phone Aplication for Smarth Phone | Device | Cell phone Aplication for Smarth Phone |
Primary outcome
Smoking cessation
Time frame: Change in smoking status from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Derived from this study: PubMed 32589153Palleja-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.
- Derived from this study: PubMed 30916655Marin-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.
- Derived from this study: PubMed 23915067Valdivieso-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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell phone Aplication for Smarth Phone in people with Smoking Cessation, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Nov 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Empar Valdivieso López, Nurse (+34675783477, evaldivieso.tarte.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (time frame: Change in smoking status from baseline at 6 months). 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 NCT01734421, which also lists 3 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 27 Nov 2012.