Trial of physical activity for smoking cessation during pregnancy

ISRCTN	ISRCTN48600346
DOI	https://doi.org/10.1186/ISRCTN48600346
Protocol serial number	HTA 07/01/14
Sponsor	St George's, University of London (UK)
Funder	Health Technology Assessment Programme

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Dr Michael Ussher
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
Email	mussher@sgul.ac.uk

Study information

Primary study design	Interventional
Study design	Pragmatic randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Prolonged smoking abstinence at end of pregnancy validated by expired CO and saliva cotinine
Key secondary outcome measure(s)	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
Completion date	30/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	866
Key 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
Key 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)
Date of first enrolment	01/04/2009
Date of final enrolment	01/11/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

St George's University of London

London
SW17 0RE
United Kingdom

Epsom and St Helier University Hospitals NHS Trust

Surrey
SM5 1AA
United Kingdom

Croydon University Hospital

Surrey
CR7 7YE
United Kingdom

Kingston Hospital

Kingston upon Thames
KT2 7QB
United Kingdom

Imperial College Healthcare NHS Trust (St Mary's, Hammersmith, Chelsea & Queen Charlotte's)

London
W2 1NY
United Kingdom

Chelsea and Westminster Hospital

London
SW10 9NH
United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London
SE1 7EH
United Kingdom

Crawley Hospital

Crawley
RH11 7DH
United Kingdom

King's College Hospital

London
SE5 9RS
United Kingdom

Medway Maritime Hospital

Gillingham
ME7 5NY
United Kingdom

West Middlesex University Hospital

Middlesex
TW7 6AF
United Kingdom

Leighton Hospital, Mid-Cheshire Hospital Trust

Cheshire
CW1 4QJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/05/2015		Yes	No
Results article	results	01/10/2015		Yes	No
Protocol article	protocol	04/10/2012		Yes	No
Other publications	process evaluation	17/01/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.