NCT01073085

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,478

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

1.8 years

First QC Date

February 19, 2010

Last Update Submit

January 16, 2014

Conditions

Tobacco Consumption

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 months after inclusion

Study Arms (2)

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.

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.

Behavioral: Self-help guide

Interventions

Web-based automated "coaching" by e-mailsBEHAVIORAL
Web-based coaching
Self-help guideBEHAVIORAL
Self-help guide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No personal e-mail address
  • Not able to give the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut national de prevention et d'education pour la sante

Saint-Denis, 93203, France

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Pierre Arwidson, Doctor

    Institut national de prevention et d'education pour la sante

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Directeur des affaires scientifiques

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 23, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

FR(1)