Contact information
Type
Scientific
Primary contact
Dr Paul Aveyard
ORCID ID
Contact details
Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8529
p.n.aveyard@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MREC 99/7/50
Study information
Scientific title
Acronym
Study hypothesis
That interventions based on the TTM would help more pregnant smokers stop smoking than standard care.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Smoking in pregnancy
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Biochemically confirmed continuous abstinence for 10 weeks at the end of pregnancy.
Secondary outcome measures
Point prevalence abstinence, self-reported abstinence.
Overall trial start date
01/03/1999
Overall trial end date
31/03/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Pregnant, aged at least 16 years of age, smoking at the time of booking for maternity care, able to read English.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
918
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/1999
Recruitment end date
31/03/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Dr Brendan Laverty
Research & Enterprise Services
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
b.w.laverty@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
West Midlands Health Authorities (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
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
Publication citations
-
Results
Aveyard P, Lawrence T, Evans O, Cheng KK, The influence of in-pregnancy smoking cessation programmes on partner quitting and women's social support mobilization: a randomized controlled trial [ISRCTN89131885]., BMC Public Health, 2005, 5, 80, doi: 10.1186/1471-2458-5-80.
-
Results
Aveyard P, Lawrence T, Cheng KK, Griffin C, Croghan E, Johnson C, A randomized controlled trial of smoking cessation for pregnant women to test the effect of a transtheoretical model-based intervention on movement in stage and interaction with baseline stage., Br J Health Psychol, 2006, 11, Pt 2, 263-278, doi: 10.1348/135910705X52534.
-
Results
Aveyard P, Lawrence T, Croghan E, Evans O, Cheng KK, Is advice to stop smoking from a midwife stressful for pregnant women who smoke? Data from a randomized controlled trial., Prev Med, 2005, 40, 5, 575-582, doi: 10.1016/j.ypmed.2004.07.012.
-
Cohort results
Lawrence T, Aveyard P, Croghan E, What happens to women's self-reported cigarette consumption and urinary cotinine levels in pregnancy?, Addiction, 2003, 98, 9, 1315-1320.
-
Results
Lawrence T, Aveyard P, Evans O, Cheng KK, A cluster randomised controlled trial of smoking cessation in pregnant women comparing interventions based on the transtheoretical (stages of change) model to standard care., Tob Control, 2003, 12, 2, 168-177.
-
Lawrence T, Aveyard P, Cheng KK, Griffin C, Johnson C, Croghan E, Does stage-based smoking cessation advice in pregnancy result in long-term quitters? 18-month postpartum follow-up of a randomized controlled trial., Addiction, 2005, 100, 1, 107-116, doi: 10.1111/j.1360-0443.2005.00936.x.