Condition category
Mental and Behavioural Disorders
Date applied
23/07/2012
Date assigned
26/07/2012
Last edited
09/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study aims to determine whether it is feasible to deliver online screening and brief intervention via the workplace, and whether doing so reduces alcohol consumption. The study will determine what proportion of people offered screening accept it, what proportion who accept are drinking above recommended guidelines, what proportion make use of an online intervention to help them drink less and how effective the intervention is amongst those who use it.

Who can participate?
The HOW study aims to recruit 1,840 employees aged 18 and above from a large international organisation, based in the UK.

What does the study involve?
Employees who wish to take part will be asked to complete an online health questionnaire which will takes about 10 minutes. The questionnaire includes questions on height, weight, smoking alcohol intake, diet and physical activity. Participants will receive instantaneous online feedback based on their answers, with information about what they are already doing that's good for their health and what they might want to change. There will also be suggestions on where to get help if needed. Some participants will be contacted again in 3 months' time to complete further questionnaires.

What are the possible benefits and risks of participating?
Participants will receive a personalised health check, together with advice about how to improve their health. This is completely free, and completely confidential. Participants may get a shock if the results of the health check suggest they are at risk of a health problem. If they are worried about their health and feel they need more advice than we can give online, they are advised to go and see their family doctor. The doctor is the person best placed to help with health problems.

Where is the study run from?
The HOW study is based entirely online. It is being conducted by a team of researchers based in the e-Health Unit, at UCL.

When is the study starting and how long is it expected to run for?
Study recruitment is due to begin on 01 August 2012. There is a three week recruitment period, three month trial duration, and three week follow-up period. The study is due to close on the 5th December 2012.

Who is funding the study?
This study has been funded by the NIHR School for Primary Care Research.

Who is the main contact?
Dr Elizabeth Murray
elizabeth.murray@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Elizabeth Murray

ORCID ID

Contact details

University College London (UCL)
Research Department of Primary Care & Population Health
Royal Free Hospital
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7794 0500 ext. 36747
elizabeth.murray@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of work-based online screening and brief intervention for hazardous and harmful drinking

Acronym

HoW

Study hypothesis

Feedback on alcohol consumption and access to an online intervention will lead to a reduction in drinking, compared with no feedback on drinking in the context of a health check on a range of behaviours.

The null hypothesis is that there will be no difference between groups in their alcohol intake.

Ethics approval

UCL Research Ethics Committee, 11/05/2012, ref: 3770/001

Study design

Online randomised controlled trial with wait-list control group

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Reducing alcohol misuse

Intervention

Participants randomised to the intervention group will receive individually tailored feedback on body mass index (BMI), smoking status, diet and physical activity. In addition, they will be informed that the information they provided suggests that they are at increased risk of alcohol-related harm, and advised to reduce the amount they drink. The advice will acknowledge that it can be hard to cut down, and state that further support in achieving this is available from the online intervention, Down Your Drink (DYD), with an embedded hyperlink which participants can click on to be taken directly to DYD. Participants can access the DYD website as often as they wish during the 3 month trial duration.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Past week alcohol consumption, measured by the TOT-AL. This is an online measure of past week alcohol consumption, validated in a UK population.

Secondary outcome measures

1. The number (proportion) of employees completing the online health check
2. The number (proportion) of employees who complete the online health check and score 5 or more on the AUDIT-C
3. The number (proportion) of participants in the intervention group who access DYD at least once
4. Alcohol use disorders, measured by the AUDIT. This will allow comparison of our data with other alcohol trials
5. Health state, measured by the EQ-5D
6. Number of days of sickness absence in past 3 months (self-reported)
7. Number and duration of hospital admissions in past 3 months (self-reported)
8. Costs, staff time and resources required to implement intervention

Overall trial start date

01/08/2012

Overall trial end date

05/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Employees of a large international company aged 18 and over
2. Participants scoring 5 or more on the Alcohol Use Disorders Identification Test (AUDIT)-C questionnaire (three-item screening tool for alcohol misuse)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,840

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/08/2012

Recruitment end date

22/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

c/o David Wilson
Joint Research Office
149 Tottenham Court Road
London
W1T 7DN
United Kingdom
+44 (0)20 3447 5199
david.wilson@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

NIHR School for Primary Care Research (UK)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25409454

Publication citations

Additional files

Editorial Notes