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Evaluation of an Internet-based Intervention for Hazardous Drinkers

This study has been completed.
Sponsor:
Information provided by:
Institut national de prevention et d'education pour la sante
ClinicalTrials.gov Identifier:
NCT01075685
First received: January 6, 2010
Last updated: October 15, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Hazardous Alcohol Consumption
 Behavioral: interactive online programme to reduce alcohol consumption
Behavioral: Minimum information
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Further study details as provided by Institut national de prevention et d'education pour la sante:

Primary Outcome Measures:
  • Change in Weekly Alcohol Intake [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Relative Change in Weekly Alcohol Intake [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    (6 weeks minus baseline)/baseline

  • Category of Change in Weekly Alcohol Intake [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]

    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.

  • Change in the Number of Excessive Drinkers [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 1157
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 6, 2010
Results First Received: August 19, 2010
Last Updated: October 15, 2010
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on June 18, 2013