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ISRCTN
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ISRCTN89131885
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ClinicalTrials.gov identifier
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Public title
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An evaluation of the relative effectiveness of interventions based on the transtheoretical model (TTM) of behaviour change (stages of change) compared with standard care in helping women to stop smoking in pregnancy
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Scientific title
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Acronym
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N/A
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Serial number at source
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MREC 99/7/50
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Study hypothesis
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That interventions based on the TTM would help more pregnant smokers stop smoking than standard care.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Smoking in pregnancy
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Participants - inclusion criteria
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Pregnant, aged at least 16 years of age, smoking at the time of booking for maternity care, able to read English.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/03/1999
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Anticipated end date
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31/03/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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918
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Interventions
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A cluster randomized trial of three interventions:
1. Standard care
2. Self-help manual and enhanced stage-based counselling
3. Self-help manual, enhanced stage-based counselling and use of an interactive computer program
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Primary outcome measure(s)
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Biochemically confirmed continuous abstinence for 10 weeks at the end of pregnancy.
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Secondary outcome measure(s)
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Point prevalence abstinence, self-reported abstinence.
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Sources of funding
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West Midlands Health Authorities (UK)
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16053527
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16643698
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15749141
18-month postpartum follow-up:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15598198
Cohort results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12930219
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12773727
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Contact name
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Dr
Paul
Aveyard
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Address
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Department of Primary Care & General Practice
University of Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 8529
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Email
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p.n.aveyard@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Dr Brendan Laverty
Research & Enterprise Services
University of Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 7618
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Email
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b.w.laverty@bham.ac.uk
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Date applied
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05/07/2005
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Last edited
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04/01/2008
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Date ISRCTN assigned
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07/07/2005
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