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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014