Brief Intervention for Heavy Drinkers
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Brief intervention
Control group
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Abuse focused on measuring Heavy drinking, Brief intervention, Alcohol prevention, Randomized trial, Motivational interviewing, Intervention Studies, prevention & control
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.
Sites / Locations
- The municipality of Naestved
- The municipiality of Aeroe
- The municipiality of Albertslund
- The municipiality of Broendby
- The municipiality of Frederiksberg
- The municipality of Guldborgsund
- The municipiality of Faaborg-Midtfyn
- The municipiality of Silkeborg
- The municipiality of Varde
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00728767
First Posted
August 1, 2008
Last Updated
April 13, 2011
Sponsor
University of Southern Denmark
Collaborators
National Board of Health, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00728767
Brief Title
Brief Intervention for Heavy Drinkers
Official Title
Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Southern Denmark
Collaborators
National Board of Health, Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
Heavy drinking, Brief intervention, Alcohol prevention, Randomized trial, Motivational interviewing, Intervention Studies, prevention & control
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
772 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Brief intervention
Intervention Description
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?"
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders B. Gottlieb Hansen, cand.techn.soc
Organizational Affiliation
University of Southern Denmark, National Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The municipality of Naestved
City
Naestved
State/Province
Næstved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
The municipiality of Aeroe
City
Aeroeskoebing
ZIP/Postal Code
5970
Country
Denmark
Facility Name
The municipiality of Albertslund
City
Albertslund
ZIP/Postal Code
2620
Country
Denmark
Facility Name
The municipiality of Broendby
City
Brøndby
ZIP/Postal Code
2605
Country
Denmark
Facility Name
The municipiality of Frederiksberg
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
The municipality of Guldborgsund
City
Nykøbing F.
ZIP/Postal Code
4800
Country
Denmark
Facility Name
The municipiality of Faaborg-Midtfyn
City
Ringe
ZIP/Postal Code
5750
Country
Denmark
Facility Name
The municipiality of Silkeborg
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
The municipiality of Varde
City
Varde
ZIP/Postal Code
6800
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21949192
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.
Results Reference
derived
Learn more about this trial
Brief Intervention for Heavy Drinkers
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