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CompletedNCT00728767Updated Apr 14, 2011

Brief Intervention for Heavy Drinkers

A Phase 3 interventional study of Brief intervention and Control group in Alcohol Abuse, sponsored by University of Southern Denmark. Completed at 9 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-14.

Sponsored by University of Southern Denmark · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
772
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alcohol Abuse

Keywords

  • Heavy drinking
  • Brief intervention
  • Alcohol prevention
  • Randomized trial
  • Motivational interviewing
  • Intervention Studies
  • prevention & control
03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 772 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
772 participants (actual)

Study arms

  • Experimental
    1

    Other: Brief intervention

  • Placebo comparator
    2

    Other: Control group

Interventions

  • OtherBrief intervention

    The intervention consists of a brief conversation based on the principles of motivational interviewing, including Rollnicks scales to assess the motivation and importance for change. The intervention has duration of about 10 minutes and qualifies as a hybrid between a minimal intervention and a brief intervention. The intervention also consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol above recommended limits, 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. Employees had been instructed to ask these questions during the intervention: "What are you already doing to restrain your drinking?" And "What can you do more?"

  • OtherControl group

    The intervention consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol use above the recommended limits, and a sheet about local alcohol treatment possibilities.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

9 sites
  • The municipality of Naestved
    Naestved, Næstved 4700, Denmark
  • The municipiality of Aeroe
    Aeroeskoebing, 5970, Denmark
  • The municipiality of Albertslund
    Albertslund, 2620, Denmark
  • The municipiality of Broendby
    Brøndby, 2605, Denmark
  • The municipiality of Frederiksberg
    Frederiksberg, 2000, Denmark
  • The municipality of Guldborgsund
    Nykøbing F., 4800, Denmark
  • The municipiality of Faaborg-Midtfyn
    Ringe, 5750, Denmark
  • The municipiality of Silkeborg
    Silkeborg, 8600, Denmark
  • The municipiality of Varde
    Varde, 6800, Denmark
08

References and documents

Publications

  • Hansen AB, Becker U, Nielsen AS, Gronbaek M, Tolstrup JS. Brief alcohol intervention by newly trained workers versus leaflets: comparison of effect in older heavy drinkers identified in a population health examination survey: a randomized controlled trial. Alcohol Alcohol. 2012 Jan-Feb;47(1):25-32. doi: 10.1093/alcalc/agr140. Epub 2011 Sep 22. PubMed 21949192 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00728767
Lead sponsor
University of Southern Denmark
Collaborators
National Board of Health, Denmark
First posted
Aug 6, 2008
Start date
Jan 2008
Primary completion
Nov 2008
Completion
Dec 2009
Last update
Apr 14, 2011

Study contacts

Anders B. Gottlieb Hansen, cand.techn.soc
principal investigator · University of Southern Denmark, National Institute of Public Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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