NCT00728767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
772

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 14, 2011

Status Verified

August 1, 2009

Enrollment Period

10 months

First QC Date

August 1, 2008

Last Update Submit

April 13, 2011

Conditions

Alcohol Abuse

Keywords

Heavy drinkingBrief interventionAlcohol preventionRandomized trialMotivational interviewingIntervention Studiesprevention & control

Outcome Measures

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.

    6 and 12 months

Study Arms (2)

1

EXPERIMENTAL
Other: Brief intervention

2

PLACEBO COMPARATOR
Other: Control group

Interventions

Brief interventionOTHER

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?"

1
Control groupOTHER

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.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The municipality of Naestved

Næstved, Næstved, 4700, Denmark

Location

The municipiality of Aeroe

Aeroeskoebing, 5970, Denmark

Location

The municipiality of Albertslund

Albertslund, 2620, Denmark

Location

The municipiality of Broendby

Brøndby, 2605, Denmark

Location

The municipiality of Frederiksberg

Frederiksberg, 2000, Denmark

Location

The municipality of Guldborgsund

Nykøbing Falster, 4800, Denmark

Location

The municipiality of Faaborg-Midtfyn

Ringe, 5750, Denmark

Location

The municipiality of Silkeborg

Silkeborg, 8600, Denmark

Location

The municipiality of Varde

Varde, 6800, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 21949192DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Crisis InterventionControl Groups

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Anders B. Gottlieb Hansen, cand.techn.soc

    University of Southern Denmark, National Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2008

Study Completion

December 1, 2009

Last Updated

April 14, 2011

Record last verified: 2009-08

Locations

DK(9)