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Completed

NCT Number: NCT01075685

Evaluation of an Internet-based Intervention for Hazardous Drinkers

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

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Key information

Conditions

Hazardous Alcohol Consumption

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

interactive online programme to reduce alcohol consumption

Behavioral

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.

Minimum information

Behavioral

This intervention includes:

  • information about hazardous drinking
  • an alcohol diary

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut national de prevention et d'education pour la sante

Other Gov

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2010
Registry last updated
Nov 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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