Evaluation of an Internet-based Intervention for Hazardous Drinkers

Hazardous Alcohol Consumption Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075685
• Other study ID #: Evalcoometre
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2010
• Last updated: October 15, 2010
• Start date: October 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Institut national de prevention et d'education pour la sante
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1157
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Study Design

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Hazardous Alcohol Consumption

Intervention

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.
• Minimum information
This intervention includes: information about hazardous drinking an alcohol diary

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut national de prevention et d'education pour la sante

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weekly Alcohol Intake	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.	baseline and 6 weeks	No
Secondary	Relative Change in Weekly Alcohol Intake	(6 weeks minus baseline)/baseline	baseline and 6 weeks	No
Secondary	Category of Change in Weekly Alcohol Intake	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.	baseline and 6 weeks	No
Secondary	Change in the Number of Excessive Drinkers	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	baseline and 6 weeks	No