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Evaluation of an Internet-based Intervention for Hazardous Drinkers

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ClinicalTrials.gov Identifier: NCT01075685
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : November 10, 2010
Last Update Posted : November 10, 2010
Sponsor:
Information provided by:
Institut national de prevention et d'education pour la sante

Brief Summary:
The purpose of this study is to determine whether the investigators internet-based intervention is effective to help hazardous drinkers reducing their alcohol consumption.

Condition or disease Intervention/treatment Phase
Hazardous Alcohol Consumption Behavioral: interactive online programme to reduce alcohol consumption Behavioral: Minimum information Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Web-based alcohol programme

Participants could log on to their account and access the programme whenever they wanted to.

They received automated email reminders inviting them to use follow-up tools, especially the diary in order to register their alcohol intake on the previous week:

  • 4 weeks after starting the programme, so that they would take advantage of the monitoring stage in case they had not spontaneously done so.
  • 2 weeks later for 6-week follow-up.
Behavioral: interactive online programme to reduce alcohol consumption

The programme includes several steps:

  • personalized feedback on alcohol consumption and related risks
  • reviewing motivations and fears regarding drinking reduction
  • analyse of drinking habits
  • reduction goal setting
  • follow-up tools (alcohol diary, craving scales, well-being scales)
  • a final screen allowing participants to monitor their progress through graphs and automatically adapted comments.
Placebo Comparator: Minimum information
Participants could log on to their account and access the programme whenever they wanted to. At 6 week follow-up they received an automated email reminder inviting them to use the diary in order to register their alcohol intake on the previous week.
Behavioral: Minimum information

This intervention includes:

  • information about hazardous drinking
  • an alcohol diary



Primary Outcome Measures :
  1. Change in Weekly Alcohol Intake [ Time Frame: baseline and 6 weeks ]
    The unit of "standard drink" is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks.


Secondary Outcome Measures :
  1. Relative Change in Weekly Alcohol Intake [ Time Frame: baseline and 6 weeks ]
    (6 weeks minus baseline)/baseline

  2. Category of Change in Weekly Alcohol Intake [ Time Frame: baseline and 6 weeks ]

    Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are:

    • clinically significant reduction in WAI, defined as a decrease of 10% or over;
    • clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0);
    • and no clinically significant change, which includes all other cases.

  3. Change in the Number of Excessive Drinkers [ Time Frame: baseline and 6 weeks ]
    The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12

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): NCT01075685


Sponsors and Collaborators
Institut national de prevention et d'education pour la sante
Investigators
Principal Investigator: Juliette Guillemont, MS Institut national de prevention et d'education pour la sante

Responsible Party: Guillemont, Institut national de prevention et d'education pour la sante
ClinicalTrials.gov Identifier: NCT01075685     History of Changes
Other Study ID Numbers: Evalcoometre
First Posted: February 25, 2010    Key Record Dates
Results First Posted: November 10, 2010
Last Update Posted: November 10, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs