Web-based Ultra-brief Intervention for Heavy Drinkers Trial

April 13, 2011 updated by: University of Southern Denmark

Web-based Ultra-brief Intervention for Heavy Drinkers - a Randomized Controlled Trial Comparing Personalized Normative Feedback With Self-help Material

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

1380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1399
        • University of Southern Denmark, National Institute of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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.
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.
EXPERIMENTAL: 2
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.
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.
PLACEBO_COMPARATOR: 3
Control
Other: Control
The participant is being informed about their allocation to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
Outcome measure was based on self-reported drinking during a typical week.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

National Board of Health, Denmark

Investigators

  • Principal Investigator: Anders B. Gottlieb Hansen, Ph.d.-student, cand.techn.soc, University of Southern Denmark, National Institute of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (ESTIMATE)

September 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPH - 1948b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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