Trial of physical activity for smoking cessation during pregnancy
| ISRCTN | ISRCTN48600346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48600346 |
| Secondary identifying numbers | HTA 07/01/14 |
- Submission date
- 17/07/2008
- Registration date
- 21/07/2008
- Last edited
- 19/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
We are carrying out a study of pregnant smokers to see if exercise can help pregnant women stop smoking. To do this we will compare the effect on quit rates at end of pregnancy for two treatments:
1. Usual stop smoking support
2. Usual stop smoking support plus a physical activity intervention
Who can participate?
Pregnant women who currently smoke at least one cigarette a day and least five cigarettes daily before pregnancy, are 10- 24 weeks into their pregnancy, are motivated to quit smoking, and are aged 16-50 years.
What does the study involve?
Participants will be allocated to one of two groups. One group will receive 6 sessions of stop smoking support and the other group will receive this stop smoking support plus 14 physical activity sessions (involving exercise on a treadmill and counselling about increasing physical activity levels).
What are the possible benefits and risks of participating?
The benefit of participating would be that you receive one-to-one advice on how to stop smoking which will increase your chances of stopping smoking. Information from this study may help other pregnant women to stop smoking. Unless you have been advised by your doctor or midwife not to take exercise, there are no disadvantages and risks of taking part. If you have been advised by your doctor or midwife not to take exercise you will not be able to take part.
Where is the study run from?
The study is run from St George's University of London, who are sponsoring the trial. Recruitment, however, takes place at 12 UK hospitals:
1. St George's, London
2. Epsom & St Helier
3. Croydon University Hospital
4. Kingston
5. Imperial (St Mary's, Hammersmith, Chelsea & Queen Charlottes)
6. Chelsea & Westminster
7. Guys & St Thomas'
8. Crawley
9. Kings College London
10. Medway Maritime Hospital
11. West Middlesex University Hospital
12. Leighton Hospital, Mid-Cheshire Hospital Trust
When is the study starting and how long is it expected to run for?
Recruitment started in April 2009 and we aim to finish recruiting by November 2012. We will follow-up participants at the end of their pregnancy and six months after to check their progress. We aim to finish this by July 2013.
Who is funding the study?
National Institute of Health Research Health Technology Assessment (NIHR HTA) programme
Who is the main contact?
Dr Michael Ussher
mussher@sgul.ac.uk
Contact information
Scientific
Division of Community Health Sciences
St George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
| Phone | +44 (0)20 8725 5605 |
|---|---|
| mussher@sgul.ac.uk |
Study information
| Study design | Pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pragmatic randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy |
| Study acronym | LEAP (London Exercise And Pregnant smokers) Trial |
| Study hypothesis | This study is assessing whether taking part in a physical activity programme enhances rates of smoking abstinence at end of pregnancy. More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/070114/#/ |
| Ethics approval(s) | Wandsworth LREC, 14/10/2008, ref: 08/H0803/177 |
| Condition | Smoking addiction |
| Intervention | Physical activity intervention: 14 sessions of supervised exercise (30 mins of brisk walking on a treadmill) plus physical activity counselling over 8 weeks plus 6 sessions of behavioural support for smoking cessation over 6 weeks. Control: Six sessions of behavioural support for smoking cessation over 6 weeks |
| Intervention type | Behavioural |
| Primary outcome measure | Prolonged smoking abstinence at end of pregnancy validated by expired CO and saliva cotinine |
| Secondary outcome measures | 1. Reports of physical activity, recorded throughout treatment, at end of pregnancy and six months after birth 2. Withdrawal symptoms, assessed during treatment 3. Desire to smoke, assessed during treatment 4. Self-efficacy for physical activity and for quitting smoking, assessed throughout treatment, at end of pregnancy and six months after birth 5. Depression, measured by the Edinburgh Post-natal Depression Scale throughout treatment, at end of pregnancy and six months after birth 6. Weight/ body mass index (BMI), assessed throughout treatment, at end of pregnancy and six months after birth |
| Overall study start date | 01/02/2009 |
| Overall study end date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 866 |
| Participant inclusion criteria | 1. Pregnant women, no more than 24 weeks pregnant 2. 16 to 50 years of age 3. Currently smoking at least one cigarette a day 4. Report smoking at least ten cigarettes daily before pregnancy 5. Motivated to quit smoking |
| Participant exclusion criteria | 1. Injury or illness that might be exacerbated by exercise. If they have been advised by their doctor or midwife not to take exercise during pregnancy or if they have any cautions for taking exercise a consultant Obstetrician and Gynecologist at their hospital will be consulted to check that it is safe for them to take part in the trial 2. Women who wish to use nicotine replacement therapy (NRT) |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 01/11/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
SW17 0RE
United Kingdom
SM5 1AA
United Kingdom
CR7 7YE
United Kingdom
KT2 7QB
United Kingdom
W2 1NY
United Kingdom
SW10 9NH
United Kingdom
SE1 7EH
United Kingdom
RH11 7DH
United Kingdom
SE5 9RS
United Kingdom
ME7 5NY
United Kingdom
TW7 6AF
United Kingdom
CW1 4QJ
United Kingdom
Sponsor information
University/education
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
| Phone | +44 (0)20 8725 5000 |
|---|---|
| awithers@sgul.ac.uk | |
| Website | http://www.sgul.ac.uk |
"ROR" |
https://ror.org/040f08y74 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/10/2012 | Yes | No | |
| Results article | results | 14/05/2015 | Yes | No | |
| Results article | results | 01/10/2015 | Yes | No | |
| Other publications | process evaluation | 17/01/2017 | Yes | No |
Editorial Notes
19/01/2017: Publication reference added.
03/09/2009: The overall trial start and end dates were changed from 01/10/2008 and 31/12/2012 to 01/02/2009 and 30/04/2013, respectively.
