Clinical trial NCT00751985: Web-based Ultra-brief Intervention for Heavy Drinkers Trial
Official title: Web-based Ultra-brief Intervention for Heavy Drinkers - a Randomized Controlled Trial Comparing Personalized Normative Feedback With Self-help Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alcohol Abuse
Keywords: Heavy drinking
Ultra-brief intervention
Brief intervention
Alcohol prevention
Randomized trial
Personal normative feedback
Self-help material
Web-based
Intervention Studies
prevention & control
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: National Board of Health, Denmark
First posted: 2008-09-12
Enrollment: 1380
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 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.

Detailed description: Background and purpose:

The Danish national board of Health has awarded funds for 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 (PFI) B) an intervention group receiving web-based self-help material (SHM) 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 (internetbased and paper).

Eligibility criteria: Inclusion Criteria:

* Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.
* 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.
* Participants who have not informed their email address.

Primary outcomes:
measure: Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Southern Denmark, National Institute of Public Health
Study officials:
affiliation: University of Southern Denmark, National Institute of Public Health
name: Anders B. Gottlieb Hansen, Ph.d.-student, cand.techn.soc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansen AB, Becker U, Nielsen AS, Gronbaek M, Tolstrup JS, Thygesen LC. Internet-based brief personalized feedback intervention in a non-treatment-seeking population of adult heavy drinkers: a randomized controlled trial. J Med Internet Res. 2012 Jul 30;14(4):e98. doi: 10.2196/jmir.1883.