- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01075685
Evaluation of an Internet-based Intervention for Hazardous Drinkers
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Alcohol Use Disorders Identification Test (AUDIT) score from 6 (female) or 7 (male) to 12
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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:
|
The programme includes several steps:
|
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.
|
This intervention includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative Change in Weekly Alcohol Intake
Time Frame: baseline and 6 weeks
|
(6 weeks minus baseline)/baseline
|
baseline and 6 weeks
|
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:
|
baseline and 6 weeks
|
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
|
baseline and 6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Juliette Guillemont, MS, Institut national de prevention et d'education pour la sante
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Evalcoometre
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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