Clinical trial NCT00728767: Brief Intervention for Heavy Drinkers
Official title: Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Abuse
Keywords: Heavy drinking
Brief intervention
Alcohol prevention
Randomized trial
Motivational interviewing
Intervention Studies
prevention & control
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: National Board of Health, Denmark
First posted: 2008-08-06
Enrollment: 772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
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.
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: The municipality of Naestved
state: Næstved
city: Aeroeskoebing
country: Denmark
facility: The municipiality of Aeroe
city: Albertslund
country: Denmark
facility: The municipiality of Albertslund
city: Brøndby
country: Denmark
facility: The municipiality of Broendby
city: Frederiksberg
country: Denmark
facility: The municipiality of Frederiksberg
city: Nykøbing F.
country: Denmark
facility: The municipality of Guldborgsund
city: Ringe
country: Denmark
facility: The municipiality of Faaborg-Midtfyn
city: Silkeborg
country: Denmark
facility: The municipiality of Silkeborg
city: Varde
country: Denmark
facility: The municipiality of Varde
Study officials:
affiliation: University of Southern Denmark, National Institute of Public Health
name: Anders B. Gottlieb Hansen, cand.techn.soc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.