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Web-based Ultra-brief Intervention for Heavy Drinkers Trial

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Personalised normative feedback (PNF)
Self-help material
Control
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Abuse focused on measuring Heavy drinking, Ultra-brief intervention, Brief intervention, Alcohol prevention, Randomized trial, Personal normative feedback, Self-help material, Web-based, Intervention Studies, prevention & control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern Denmark, National Institute of Public Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Personalized normative feedback (PFI). The PFI was a single-session intervention; it was displayed in a single screenshot and addressed the participant by name. It consisted of a summary of the participant's weekly consumption, a comparison with maximum drinking limits and a graphical comparison of the participant's consumption to the average level in the municipality (gender-specific), followed by information about health and social risks of heavy drinking as well as links for further self-help material and a local alcohol treatment facility.

Self-help material (SHM). The SHM was a single-session intervention and was displayed in a single screenshot. It consisted of information about maximum drinking limits, followed by information about health and social risks of heavy drinking as well as links for further standardized self-help material and a local alcohol treatment facility.

Control

Outcomes

Primary Outcome Measures

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.
Outcome measure was based on self-reported drinking during a typical week.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2008
Last Updated
April 13, 2011
Sponsor
University of Southern Denmark
Collaborators
National Board of Health, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00751985
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Personalized normative feedback (PFI). The PFI was a single-session intervention; it was displayed in a single screenshot and addressed the participant by name. It consisted of a summary of the participant's weekly consumption, a comparison with maximum drinking limits and a graphical comparison of the participant's consumption to the average level in the municipality (gender-specific), followed by information about health and social risks of heavy drinking as well as links for further self-help material and a local alcohol treatment facility.
Arm Title
2
Arm Type
Experimental
Arm Description
Self-help material (SHM). The SHM was a single-session intervention and was displayed in a single screenshot. It consisted of information about maximum drinking limits, followed by information about health and social risks of heavy drinking as well as links for further standardized self-help material and a local alcohol treatment facility.
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Control
Intervention Type
Other
Intervention Name(s)
Personalised normative feedback (PNF)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Self-help material
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The participant is being informed about their allocation to the control group.
Primary Outcome Measure Information:
Title
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.
Description
Outcome measure was based on self-reported drinking during a typical week.
Time Frame
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders B. Gottlieb Hansen, Ph.d.-student, cand.techn.soc
Organizational Affiliation
University of Southern Denmark, National Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern Denmark, National Institute of Public Health
City
Copenhagen
ZIP/Postal Code
1399
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
22846542
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.
Results Reference
derived

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Web-based Ultra-brief Intervention for Heavy Drinkers Trial

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