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 |
| Protocol serial number | MREC 99/7/50 |
| Sponsor | University of Birmingham (UK) |
| Funder | West Midlands Health Authorities (UK) |
- 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
Scientific
Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 8529 |
|---|---|
| p.n.aveyard@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | That 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) studied | 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 |
| Primary outcome measure(s) | Biochemically confirmed continuous abstinence for 10 weeks at the end of pregnancy. |
| Key secondary outcome measure(s) | Point prevalence abstinence, self-reported abstinence. |
| Completion date | 31/03/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 918 |
| Key inclusion criteria | Pregnant, aged at least 16 years of age, smoking at the time of booking for maternity care, able to read English. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/1999 |
| Date of final enrolment | 31/03/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
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 | 01/06/2003 | Yes | No | |
| Results article | Cohort results: | 01/09/2003 | Yes | 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 | |
| Abstract results | 01/01/2005 | No | No |
