Health for Izhevsk Men

ISRCTN	ISRCTN82405938
DOI	https://doi.org/10.1186/ISRCTN82405938
Protocol serial number	078557
Sponsor	London School of Hygiene and Tropical Medicine (UK)
Funder	The Wellcome Trust (UK) (grant ref: 078557)

Submission date: 28/01/2008
Registration date: 29/01/2008
Last edited: 13/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof David Leon
Scientific

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2252
Email	david.leon@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	The study will be an individually randomised, two-armed parallel group, single centre exploratory trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial of motivational interviewing to reduce hazardous drinking among Russian working-age men
Study acronym	HIM
Study objectives	The study is a trial to explore the efficacy and acceptability of a brief intervention aimed at reducing the prevalence of hazardous drinking in working age men in a typical Russian city (Izhevsk). Hypothesis: A brief adaptation of motivational interviewing will be effective in reducing self-reported hazardous drinking at 3 months.
Ethics approval(s)	Ethics approval received from the London School of Hygiene and Tropical Medicine Ethics Committee on the 16th January 2008 (ref: 5230).
Health condition(s) or problem(s) studied	Hazardous drinking
Intervention	An adaptation of Motivational Interviewing (MI) has been developed for the Russian context, and includes topics such as surrogate drinking and binge drinking (zapoi). MI involves empathic questioning and listening, with a view to the development of discrepancy between alcohol use and other goals and values and the eliciting of personalised statements about change. The full intervention comprises up to four sessions. These will be delivered at home or in a clinic by specially trained practitioners. The control group will not receive any intervention other than having a health check as part of the longitudinal study and being invited for 3 and 12 months follow-up.
Intervention type	Other
Primary outcome measure(s)	SELF report of hazardous drinking 3 months post-randomisation defined as one or more occurrences of: 1. Binge drinking (zapoi) in the past month 2. Surrogates in the past month 3. Hangover and/or excessive drunkenness and/or going to sleep clothed due to being drunk twice or more per week on average over the past month 4. 250 mls or more of ethanol from beverages in the past week from beverages (i.e., 25+ UK alcohol units)
Key secondary outcome measure(s)	SELF and PROXY report of hazardous drinking 12 months post-randomisation defined as one or more occurrences of: 1. Binge drinking (zapoi) in the past month 2. Surrogates in the past month 3. Hangover and/or excessive drunkenness and/or going to sleep clothed due to being drunk twice or more per week on average over the past month 4. 250 mls or more of ethanol from beverages in the past week from beverages (i.e., 25+ UK alcohol units) SELF completed: 5. AUDIT questionnaire (World Health Organization [WHO] developed global screening assessment of hazardous drinking 6. Leeds Dependency questionnaire 7. Short Index of Problems (SIP) questionnaire Biomarkers of: 9. Liver damage (gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST]) 10. Recent heavy drinking (carbohydrate-deficient transferrin [CDT])
Completion date	31/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	250
Key inclusion criteria	The men recruited into the trial will be drawn from a longitudinal observational study that is part of the Izhevsk Family Study II (aged 27 - 54 years). PROXY reports (or self reports for men living alone) of hazardous drinking defined as one or more occurrences of: 1. Binge drinking in the past year 2. Surrogates in the past year 3. Hangover and/or excessive drunkenness and/or going to sleep clothed due to being drunk twice or more per week on average over the past year 4. Weekly average of 250 mls or more of ethanol from beverages over the past year (i.e., 25+ UK alcohol units/week)
Key exclusion criteria	1. Refusal to have a baseline health check 2. Refusal to be followed up at 3 and 12 months Either of these criteria will result in exclusion from the trial.
Date of first enrolment	01/02/2008
Date of final enrolment	31/07/2010

Locations

Countries of recruitment

United Kingdom
England
Russian Federation

Study participating centre

London School of Hygiene and Tropical Medicine

London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/11/2011		Yes	No
Protocol article	protocol	31/03/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes