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| Sponsors and Collaborators: |
University of Southern Denmark National Board of Health, Denmark |
| Information provided by: | University of Southern Denmark |
| ClinicalTrials.gov Identifier: | NCT00751985 |
Purpose
The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, is effective in lowering self reported alcohol use in heavy drinkers.
| Condition | Intervention | Phase |
|
Alcohol Abuse |
Other: Personalised normative feedback (PNF) Other: Self-help material Other: Control |
Phase III |
| MedlinePlus related topics: | Alcohol Consumption |
| ChemIDplus related topics: | Ethanol |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Web-Based Ultra-Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial Comparing Personalized Normative Feedback With Self-Help Material |
| Estimated Enrollment: | 2300 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Experimental
Personalized normative feedback
|
Other: Personalised normative feedback (PNF)
The intervention can be classified as a minimal ultra-brief intervention consisting of only a single session. The brief personalised normative feedback will comprise the result of the participant's amount of alcohol consumption, previously given in an online questionnaire. Alongside, information about alcohol and how it might affect them at their current drinking levels is provided. The feedback is also comparing their drinking, in graphical format, to the average drinking in the municipality concerned. Contact details are also provided about local alcohol treatment possibilities if the participants feel they need further help. |
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2: Experimental
Self-help material
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Other: Self-help material
The intervention can be classified as a minimal ultra-brief intervention consisting of only a single session. The intervention comprises of on-line self-help material informing about the participant's response from an online questionnaire shows that the participant's alcohol consumption exceeds the recommended limits. Alongside, information about alcohol and how it might affect them at their current drinking levels is provided. Contact details are also provided about local alcohol treatment possibilities if the participants feel they need further help. |
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3: Placebo Comparator
Control
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Other: Control
The participant is being informed about their allocation to the control group.
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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 12 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 purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, 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) an intervention group receiving web-based personalized normative feedback (PNF) B) an intervention group receiving web-based self-help material C) a control group receiving nothing.
After 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |||||
| University of Southern Denmark, National Institute of Public Health | |||||
| Copenhagen, Denmark, 1399 | |||||
| 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 |
More Information
| Responsible Party: | National Board of Health Denmark ( Kit Broholm ) |
| Study ID Numbers: | NIPH - 1948b |
| First Received: | September 11, 2008 |
| Last Updated: | September 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00751985 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
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