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Clinical Trials/NCT00728767
NCT00728767
Completed
Phase 3

Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial

University of Southern Denmark9 sites in 1 country772 target enrollmentJanuary 2008
ConditionsAlcohol Abuse

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Alcohol Abuse
Sponsor
University of Southern Denmark
Enrollment
772
Locations
9
Primary Endpoint
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.
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
December 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Time Frame: 6 and 12 months

Study Sites (9)

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