Web-based Ultra-brief Intervention for Heavy Drinkers Trial

Phase 3

Completed

• Conditions: Alcohol Abuse

• Registration Number: NCT00751985
• Lead Sponsor: University of Southern Denmark

Brief Summary

The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.

Detailed Description

Background and purpose:

The Danish national board of Health has awarded funds for two studies that will test methods that can be used for effective and early detection of heavy drinkers. The study will be carried out in 12 Danish municipalities in 2008. The study is part of the 'Diet, Smoking, Alcohol and Exercise' nationwide health study of the Danish population. It takes place in 13 municipalities in 2007 and 2008.

The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.

Design:

The experiment is designed as a randomized controlled trial, where heavy drinkers will be allocated to either:

A) an intervention group receiving web-based personalized normative feedback (PFI) B) an intervention group receiving web-based self-help material (SHM) C) a control group receiving nothing.

After 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption (internetbased and paper).

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Status Verified: 2009-05
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1380

Inclusion Criteria

• Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
• Participants must have a weekly alcohol consumption above the recommended Danish limits (168 grams of alcohol for women, 252 grams of alcohol for men).

Exclusion Criteria

• Weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men.
• Participants who have not informed their email address.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent.	12 months	Outcome measure was based on self-reported drinking during a typical week.

Trial Locations

Locations (1)

University of Southern Denmark, National Institute of Public Health; 🇩🇰 Copenhagen, Denmark