Tobacco ConsumptionStampNCT01073085
Effectiveness of a French Automated Web-based Smoking Cessation Program
A study testing Web-based automated "coaching" by e-mails and Self-help guide in people with Tobacco Consumption, run by Institut national de prevention et d'education pour la sante at 1 site in France.
Trial summary
The purpose of this study is to investigate the effectiveness of a French fully automated web-based smoking cessation program known as the "coaching", by comparing it to an online self-help guide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Consumption
- What is being tested?
- Web-based automated "coaching" by e-mails and Self-help guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,478 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Jan 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and older
- Smoker
- Willing to quit smoking in the next two weeks
- Having a regular access to Internet
- Having a personal e-mail address
- Not having benefited from the "coaching" the investigators want to assess yet
Who cannot join
- No personal e-mail address
- Not able to give the informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Institut national de prevention et d'education pour la sante
Saint-Denis, 93203
About this study
Official title: Effectiveness of a French Automated Web-based Smoking Cessation Program : a Randomized Controlled Trial
The purpose of this study is to investigate the effectiveness of a French fully automated web-based smoking cessation program known as the "coaching", by comparing it to an online self-help guide.
- Conditions
- Tobacco Consumption
- Being tested
- Web-based automated "coaching" by e-mails, Self-help guide
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based automated "coaching" by e-mailsBehavioural
Self-help guideBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Web-based coaching | Experimental | Those in the "coaching" arm will benefit from e-mails with advice, information, support for smoking cessation. These mails will be adapted to their personal profile. Receives: Behavioral: Web-based automated "coaching" by e-mails |
| Self-help guide | Active comparator | Those in the "active comparator arm" will be allowed to download a self-help guide with step-by-step advice for smoking cessation. Receives: Behavioral: Self-help guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the percentage of abstinent people between the two arms of the trial, 6 months after inclusion
The investigators will compare the percentage of smokers who successfully quit, 6 months after their inclusion in the study. Point prevalence abstinence will be measured (not smoking, event a puff, in the week preceding the questioning).
Measured: 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco ConsumptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut national de prevention et d'education pour la sante
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Pierre Arwidson, Institut national de prevention et d'education pour la sante
- Investigators
- Pierre Arwidson, Doctor, Study director, Institut national de prevention et d'education pour la sante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073085
- Sponsor's protocol ID
- Stamp
- Acronym
- Stamp
- Status last verified
- Jan 2014
- First submitted
- 19 Feb 2010
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a French Automated Web-based Smoking Cessation Program : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01073085
- Acronym / sponsor ID
- Stamp / Stamp
- Conditions
- Tobacco Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,478 participants (actual)
- Lead sponsor
- Institut national de prevention et d'education pour la santeOther government
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Feb 2010 (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.
The purpose of this study is to investigate the effectiveness of a French fully automated web-based smoking cessation program known as the "coaching", by comparing it to an online self-help guide.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based coaching | Experimental | Behavioral: Web-based automated "coaching" by e-mailsThose in the "coaching" arm will benefit from e-mails with advice, information, support for smoking cessation. These mails will be adapted to their personal profile. |
| Self-help guide | Active comparator | Behavioral: Self-help guideThose in the "active comparator arm" will be allowed to download a self-help guide with step-by-step advice for smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 and older
- Smoker
- Willing to quit smoking in the next two weeks
- Having a regular access to Internet
- Having a personal e-mail address
Key exclusion criteria (2 listed)
- No personal e-mail address
- Not able to give the informed consent
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 |
|---|---|---|
| Web-based automated "coaching" by e-mails | Behavioural | Web-based coaching |
| Self-help guide | Behavioural | Self-help guide |
Primary outcome
Comparison of the percentage of abstinent people between the two arms of the trial, 6 months after inclusion
Time frame: 6 months after inclusion
The investigators will compare the percentage of smokers who successfully quit, 6 months after their inclusion in the study. Point prevalence abstinence will be measured (not smoking, event a puff, in the week preceding the questioning).
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 17 Jan 2014.
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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.
Pierre Arwidson, Doctor study director
Institut national de prevention et d'education pour la sante
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based automated "coaching" by e-mails and Self-help guide in people with Tobacco Consumption, run by Institut national de prevention et d'education pour la sante at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 17 Jan 2014. 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 France. 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?
Comparison of the percentage of abstinent people between the two arms of the trial, 6 months after inclusion (time frame: 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jan 2014.