Condition category
Mental and Behavioural Disorders
Date applied
17/07/2008
Date assigned
21/07/2008
Last edited
23/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Ussher

ORCID ID

Contact details

Division of Community Health Sciences
St George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 5605
mussher@sgul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 07/01/14

Study information

Scientific title

Pragmatic randomised controlled trial of physical activity as an aid to smoking cessation during pregnancy

Acronym

LEAP (London Exercise And Pregnant smokers) Trial

Study hypothesis

We are assessing whether taking part in a physical activity programme enhances rates of smoking abstinence at end of pregnancy.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/070114
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0015/51711/PRO-07-01-14.pdf

On 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.

Ethics approval

Wandsworth LREC, 14/10/2008, ref: 08/H0803/177

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/02/2009

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

866

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

United Kingdom

Trial participating centre

St George's University of London
London
SW17 0RE
United Kingdom

Trial participating centre

Epsom and St Helier University Hospitals NHS Trust
Surrey
SM5 1AA
United Kingdom

Trial participating centre

Croydon University Hospital
Surrey
CR7 7YE
United Kingdom

Trial participating centre

Kingston Hospital
Kingston upon Thames
KT2 7QB
United Kingdom

Trial participating centre

Imperial College Healthcare NHS Trust (St Mary's, Hammersmith, Chelsea & Queen Charlotte's)
London
W2 1NY
United Kingdom

Trial participating centre

Chelsea and Westminster Hospital
London
SW10 9NH
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
London
SE1 7EH
United Kingdom

Trial participating centre

Crawley Hospital
Crawley
RH11 7DH
United Kingdom

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Trial participating centre

Medway Maritime Hospital
Gillingham
ME7 5NY
United Kingdom

Trial participating centre

West Middlesex University Hospital
Middlesex
TW7 6AF
United Kingdom

Trial participating centre

Leighton Hospital, Mid-Cheshire Hospital Trust
Cheshire
CW1 4QJ
United Kingdom

Sponsor information

Organisation

St George's, University of London (UK)

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 5000
awithers@sgul.ac.uk

Sponsor type

University/education

Website

http://www.sgul.ac.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23035669
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25976288
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26491878

Publication citations

  1. Protocol

    Ussher M, Aveyard P, Manyonda I, Lewis S, West R, Lewis B, Marcus B, Taylor AH, Barton P, Coleman T, Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial., Trials, 2012, 13, 186, doi: 10.1186/1745-6215-13-186.

  2. Results

    Ussher M, Lewis S, Aveyard P, Manyonda I, West R, Lewis B, Marcus B, Riaz M, Taylor A, Daley A, Coleman T, Physical activity for smoking cessation in pregnancy: randomised controlled trial, BMJ, 2015, doi: 10.1136/bmj.h2145.

  3. Results

    Ussher M, Lewis S, Aveyard P, Manyonda I, West R, Lewis B, Marcus B, Riaz M, Taylor AH, Barton P, Daley A, Essex H, Esliger D, Coleman T, The London Exercise And Pregnant smokers (LEAP) trial: a randomised controlled trial of physical activity for smoking cessation in pregnancy with an economic evaluation, Health Technol Assess, 2015, 19, 84, 1-136.

Additional files

Editorial Notes