NCT01075685

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,157

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 10, 2010

Completed
Last Updated

November 10, 2010

Status Verified

January 1, 2010

Enrollment Period

3 months

First QC Date

January 6, 2010

Results QC Date

August 19, 2010

Last Update Submit

October 15, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Relative Change in Weekly Alcohol Intake

    baseline and 6 weeks

  • Category of Change in Weekly Alcohol Intake

    baseline and 6 weeks

  • Change in the Number of Excessive Drinkers

    baseline and 6 weeks

Study Arms (2)

Web-based alcohol programme

EXPERIMENTAL

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

Minimum information

PLACEBO COMPARATOR

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

Interventions

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.

Web-based alcohol programme

This intervention includes: * information about hazardous drinking * an alcohol diary

Minimum information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

EthanolEconomics

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHealth Care Economics and Organizations

Limitations and Caveats

High rate of loss to follow-up lead to small number of subjects analyzed. Some participants were lost to follow-up even before completing baseline measures.

Results Point of Contact

Title
Juliette Guillemont
Organization
Inpes

Study Officials

  • Juliette Guillemont, MS

    Institut national de prevention et d'education pour la sante

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 6, 2010

First Posted

February 25, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

November 10, 2010

Results First Posted

November 10, 2010

Record last verified: 2010-01