Brief Intervention for Heavy Drinkers

Phase 3

Completed

• Conditions: Alcohol Abuse
• Interventions: Other: Brief intervention; Other: Control group

• Registration Number: NCT00728767
• Lead Sponsor: University of Southern Denmark

Brief Summary

The purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers.

Detailed Description

Background and purpose:

The Danish national board of Health has awarded 5.6 million DKR to 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 9 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 study will determine whether a brief intervention 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) a intervention group receiving a short (about 10 minutes) motivational conversation (build on the principles of motivational interviewing) and two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities. The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.

B) a control group receiving two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities.

The study will take place in premises linked to the 'Diet, Smoking, Alcohol and Exercise' nationwide health study.

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

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-08-01
• Study First Submitted QC: 2008-08-05
• Study First Posted: 2008-08-06
• Primary Completion: 2008-11
• Status Verified: 2009-08
• Study Completion: 2009-12
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 772

Inclusion Criteria

• Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
• Participants must have responded to an Internet questionnaire.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Brief intervention	-
2	Control group	-

Primary Outcome Measures

Name	Time	Method
Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent.	6 and 12 months

Trial Locations

Locations (9)

The municipiality of Broendby; 🇩🇰 Brøndby, Denmark

The municipality of Guldborgsund; 🇩🇰 Nykøbing F., Denmark

The municipiality of Aeroe; 🇩🇰 Aeroeskoebing, Denmark

The municipiality of Albertslund; 🇩🇰 Albertslund, Denmark

The municipiality of Varde; 🇩🇰 Varde, Denmark

The municipiality of Frederiksberg; 🇩🇰 Frederiksberg, Denmark

The municipality of Naestved; 🇩🇰 Naestved, Næstved, Denmark

The municipiality of Faaborg-Midtfyn; 🇩🇰 Ringe, Denmark

The municipiality of Silkeborg; 🇩🇰 Silkeborg, Denmark