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Brief Intervention for Heavy Drinkers

This study has been completed.
Sponsor:
Collaborator:
National Board of Health, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00728767
First received: August 1, 2008
Last updated: April 13, 2011
Last verified: August 2009

August 1, 2008
April 13, 2011
January 2008
November 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00728767 on ClinicalTrials.gov Archive Site
Not Provided
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Brief Intervention for Heavy Drinkers
Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Alcohol Abuse
  • Other: Brief 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?"

  • Other: Control 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.
  • Experimental: 1
    Intervention: Other: Brief intervention
  • Placebo Comparator: 2
    Intervention: Other: Control group
Hansen AB, Becker U, Nielsen AS, Grønbaek 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
772
December 2009
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00728767
NIPH - 1948
Yes
Kit Broholm, National Board of Health Denmark
University of Southern Denmark
National Board of Health, Denmark
Principal Investigator: Anders B. Gottlieb Hansen, cand.techn.soc University of Southern Denmark, National Institute of Public Health
University of Southern Denmark
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP