Condition category
Mental and Behavioural Disorders
Date applied
13/11/2012
Date assigned
28/12/2012
Last edited
23/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Web-based tailored programs, in which information is adapted to the needs of the individual in order to give personally relevant advice, have shown to be an effective method to improve health-related behaviors. Yet, studies assessing the effects of tailored alcohol self-help programs among adults are limited.
Since Internet-based programs suffer from high drop-out rates, it is a challenge to develop interactive programs that can maintain respondents’ attention in online interventions. In order to prevent early drop-out, and thus to increase the effectiveness of a program, different strategies could be used to hold respondents’ attention in online interventions.
The main aim of this study was to assess whether a triple-session, web-based tailored alcohol intervention (program) was effective in reducing alcohol intake among the adult drinking population. The second aim was to compare two computer tailored feedback on behavioral change, drop-out and process evaluation.

Who can participate?
In our study, we recruited approximately 1,000 adults (18+) via an online access panel (called respondi AG) in Germany.

What does the study involve?
By using questionnaires, drinking behavior, health status (i.e., symptoms of depression and chronic diseases), motivational determinants (i.e., knowledge, attitude, social influence, self-efficacy, preparatory plans, coping plans and motivational stage), and demographics were assessed among participants who were recruited via an online access panel.
The first experimental subgroup received questions and advice alternately per motivational determinant resulting in several advice sections.
The second experimental subgroup received a more traditional feedback strategy, in which one large overall advice was provided at the end of the program.
The control group only filled out three questionnaires.
The personalized advice, which directly was presented on the respondent’s computer screen, consisted of five parts in which attention was given to different psychosocial constructs of the model:
1. Knowledge and awareness
2. Pros and cons of alcohol drinking
3. Social influence
4. Preparatory action plans
5. Self-efficacy and coping plans

What are the possible benefits and risks of participating?
The main benefit was that participants received personal feedback regarding their drinking behavior and their cognitions (the process of thought) regarding alcohol consumption.
To our knowledge, there were no risks to those who have taken part in this study.

Where is the study run from?
The study was set up by Maastricht University. The program development and data analysis took place at Maastricht University. Data collection was done in collaboration with respondi AG Cologne.

When is the study starting and how long is it expected to run for?
The study started in June 2010 and ran until January 2011.

Who is funding the study?
The study was funded by CAPHRI School for Public Health and Primary Care.

Who is the main contact?
Hein de Vries, PhD
hein.devries@maastrichtuniversity.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hein De Vries

ORCID ID

Contact details

P. Debyeplein 1
Maastricht
6229HA
Netherlands
hein.devries@maastrichtuniversity.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Testing the effectiveness of a web-based tailored intervention to reduce alcohol consumption by adults

Acronym

Study hypothesis

Our hypothesis is that a three-session, web-based tailored alcohol intervention is effective in reducing alcohol intake in unhealthy drinkers. Furthermore, we have the objective to compare two computer tailored feedback strategies (alternating versus summative) on behavioral change, drop-out and appreciation of the program.

Ethics approval

An ethics approval was not necessary since this is not a medical study.

Study design

Six-month single-centre randomized waiting-list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Reducing alcohol consumption / high-risk drinking

Intervention

The intervention group was invited to visit a website consisting of questionnaires and personal feedback on drinking behavior and cognitions three times (at baseline, after three months, after six months).

We divided the experimental group in two subgroups: The intervention website for these two subgroups contained the same feedback messages. During all three feedback moments, one experimental subgroup received questions and personal advice alternately (alternate condition) whereas the other experimental subgroup obtained personal advice after answering all questions (summative condition).

The control group was invited to only fill out the three questionnaires online (at baseline, after three months, after six months). At the end of the study, the control group had the possibility to visit the website of the experimental group and thus to receive personal advice, too.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference in alcohol consumption (number of consumed alcoholic drinks / compliance with the alcohol guideline) between the experimental group and the control group after the intervention.

Secondary outcome measures

1. Difference in alcohol consumption (number of consumed alcoholic drinks / compliance with the alcohol guideline) between the two experimental subgroups after the intervention
2. Difference in drop-out rate from the intervention between the two experimental subgroups
3. Difference in process evaluation outcomes between the two experimental subgroups

Overall trial start date

07/06/2010

Overall trial end date

11/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Being a member of the online access panel respondi AG Cologne
2. Having Internet access
3. Having command of the German language
4. Being at least 18 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,000

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

07/06/2010

Recruitment end date

11/01/2011

Locations

Countries of recruitment

Germany

Trial participating centre

P. Debyeplein 1
Maastricht
6229HA
Netherlands

Sponsor information

Organisation

CAPHRI School for Public Health and Primary Care (Netherlands)

Sponsor details

Universiteitssingel 40
Maastricht
6229 ER
Netherlands

Sponsor type

University/education

Website

http://www.caphri.nl/

Funders

Funder type

University/education

Funder name

CAPHRI School for Public Health and Primary Care (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24045005

Publication citations

  1. Results

    Schulz DN, Candel MJ, Kremers SP, Reinwand DA, Jander A, de Vries H, Effects of a Web-based tailored intervention to reduce alcohol consumption in adults: randomized controlled trial., J. Med. Internet Res., 2013, 15, 9, e206, doi: 10.2196/jmir.2568.

Additional files

Editorial Notes