Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT00728767
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2008-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief Intervention for Heavy Drinkers
Sponsor:
University of Southern Denmark
Organization:
Study Overview
Official Title:
Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2009-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: