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21 May 2012
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| [ Print-friendly version ] |
| Down Your Drink: On-line Randomised Controlled Trial of an Interactive Web-based Intervention for Reducing Alcohol Consumption |
| ISRCTN | ISRCTN31070347 |
| ClinicalTrials.gov identifier | |
| Public title | Down Your Drink: On-line Randomised Controlled Trial of an Interactive Web-based Intervention for Reducing Alcohol Consumption |
| Scientific title | |
| Acronym | DYD |
| Serial number at source | G0501298 |
| Study hypothesis |
The aim of the study is to determine whether the fully interactive on-line intervention, Down Your Drink (DYD), leads to important reductions in alcohol consumption amongst members of the public at risk of harm from alcohol.
Please note that this trial was updated on 29/04/2008. All changes can be found in the relevant field under the above update date. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Ethics approval received from the University College London Research Ethics Committee on the 26 April 2007 (ref: 0825/003). |
| Study design | Complex intervention study, incorporating a phase II development stage, together with a pilot phase and a phase III, two-arm randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Alcohol consumption |
| Participants - inclusion criteria |
Current inclusion criteria as of 29/04/2008:
All participants aged 18 or over and scoring 5 or more on the AUDIT-C screening test. Previous inclusion criteria: All registrants of the How's Your Drink (HYD) website (aged 16 or over) with a functional assessment staging tool (FAST) score of 3 or more who consent to participate. |
| Participants - exclusion criteria |
Current exclusion criteria as of 29/04/2008:
1. Research participants who are under 18 years of age 2. Inability to provide informed consent due to mental incapacity or active psychotic illness 3. Inability to use intervention independently due to visual, hearing or motor handicap 4. Inability to use intervention or to complete the follow-up questionnaires independently due to poor command of English Previous exclusion criteria: 1. Research participants who are under 16 years of age 2. Inability to provide informed consent due to mental incapacity or active psychotic illness 3. Inability to use intervention independently due to visual, hearing or motor handicap 4. Inability to use intervention or to complete the follow-up questionnaires independently due to poor command of English |
| Anticipated start date | 01/07/2006 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 2600 |
| Interventions | Intervention website - DYD interactive web-based intervention, providing motivational enhancement therapy and cognitive behaviour therapy versus comparator website - How’s Your Drink (HYD), a minimally interactive website, providing information only. |
| Primary outcome measure(s) |
Current primary outcome measures as of 29/04/2008:
Data from 3 and 12-month follow-up will be analysed separately at the end of the trial. The primary end point is at 3 months. The primary outcome is reduction in alcohol consumption. The primary outcome measure will be total past week’s alcohol consumption. Previous primary outcome measures: Data from 3 and 12-month follow-up will be analysed separately at the end of the trial. The primary end point is at 3 months. The primary outcome is reduction in alcohol consumption. The primary outcome measure will be total past week’s alcohol consumption as calculated by quantity or frequency. |
| Secondary outcome measure(s) |
Added as of 29/04/2008:
1. AUDIT 2. Alcohol Problems Questionnaire (APQ) 3. Leeds Dependence Questionnaire (LDQ) 4. CORE-10 |
| Sources of funding | National Prevention Research Initiative (NPRI) (UK) |
| Trial website | |
| Publications |
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21408060
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21371988 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22100793 |
| Contact name | Prof Paul Wallace |
| Address |
Department of Primary Care and Population Sciences
University College London Archway Campus Level 2 Holborn Union Building |
| City/town | London |
| Zip/Postcode | N19 5LW |
| Country | United Kingdom |
| p.wallace@pcps.ucl.ac.uk | |
| Sponsor | University College London (UK) |
| Address |
University College London
Biomedicine Research and Development Unit Hampstead Campus |
| City/town | London |
| Zip/Postcode | NW3 2PF |
| Country | United Kingdom |
| o.avwenagha@medsch.ucl.ac.uk | |
| Date applied | 19/04/2006 |
| Last edited | 23/11/2011 |
| Date ISRCTN assigned | 06/06/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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