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

ISRCTN ISRCTN89131885
DOI https://doi.org/10.1186/ISRCTN89131885
Secondary identifying numbers MREC 99/7/50
Submission date
05/07/2005
Registration date
07/07/2005
Last edited
04/01/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Aveyard
Scientific

Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone +44 (0)121 414 8529
Email p.n.aveyard@bham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study objectivesThat interventions based on the TTM would help more pregnant smokers stop smoking than standard care.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSmoking in pregnancy
InterventionA 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 typeOther
Primary outcome measureBiochemically confirmed continuous abstinence for 10 weeks at the end of pregnancy.
Secondary outcome measuresPoint prevalence abstinence, self-reported abstinence.
Overall study start date01/03/1999
Completion date31/03/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants918
Key inclusion criteriaPregnant, aged at least 16 years of age, smoking at the time of booking for maternity care, able to read English.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/03/1999
Date of final enrolment31/03/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Dr Brendan Laverty
Research & Enterprise Services
University of Birmingham
Birmingham
B15 2TT
England
United Kingdom

Phone +44 (0)121 414 7618
Email b.w.laverty@bham.ac.uk
ROR logo "ROR" https://ror.org/03angcq70

Funders

Funder type

Government

West Midlands Health Authorities (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/06/2003 Yes No
Results article Cohort results: 01/09/2003 Yes No
Abstract results 01/01/2005 No No
Results article Results 01/05/2005 Yes No
Results article Results 29/07/2005 Yes No
Results article Results 01/05/2006 Yes No