1. Helping pregnant smokers stop: intervention insights from LEAP Michael Ussher Professor of Behavioural Medicine St George’s, University of London

2. Collaborators and funding The London Exercise And Pregnant smokers (LEAP) study Collaborators: Sarah Lewis, Paul Aveyard, Isaac Manyonda, Robert West, Beth Lewis, Bess Marcus, Muhammad Riaz, Adrian Taylor, Tim Coleman Funders: National Institute of Health Research (NIHR), Health Technology Assessment (HTA) programme

3. Aims of talk Brief description of methodology Main findings Insights gained, particularly regarding recruitment, intervention delivery and maxmising attendance Published protocol: Ussher et al (2012) Physical activity as an aid to smoking cessation during pregnancy: the LEAP randomised trial protocol. Trials, 13:186.

4. Rationale: Why might physical activity aid smoking cessation during pregnancy? Increased quit rates in non-pregnant smokers (Ussher et al 2012, Marcus B et al 1999) Reduced cravings (Haasova et al 2012, Prapavessis H et al 2014, Physical activity recommended in pregnancy Alternative to Nicotine Replacement Therapy Pilot study

5. Study design Two-arm randomised controlled trial Compared quit rates at end of pregnancy for: Behavioural support for smoking cessation versus Behavioural support for smoking cessation plus physical activity intervention

6. Interventions Physical activity intervention 14 sessions 30 mins treadmill walking: x2/week for 6 weeks, x1/week for 2 weeks PA counselling: x1/week for 8 weeks Smoking cessation support Once a week for 6 weeks delivered one-to-one by midwives combined smoking cessation and PA PA counselling partly while on treadmill Provided pedometers & DVD

7. Annual lottery with three prizes of £100 for attending at least 80% of treatment sessions £7 travel expenses for each session attended £10 for follow-up at end of pregnancy Financial incentives

8. Who was eligible? Agree to set a quit date Smoking at > 1 cigarette a day now and > 5 a day before pregnancy Able to walk for at least 15 minutes 10-24 weeks gestation Willing not to use Nicotine Replacement Therapy at outset

9. Recruitment methods Recruited from 13 hospitals Duration of recruitment: 3 years, 8 months Recruitment Methods N=785 No. (%) Midwife referral 544 (69.3%) Direct calling 213 (27.1%) questionnaire at ultrasound scan 11 (1.4%) flyer8 (1.0%) referral from other health professional 7 (0.9%) poster2 (0.3%)

10. Unable to contact: 2169 (26.8%) Not interested: 2324 (28.7%) Not eligible: 2583 (31.9%) Had other reasons: 231 (2.9%) Physical activity intervention group N= 394 Two post-randomisation exclusions Control group N= 395 Two post-randomisation exclusions Pregnant smokers identified: N=8096 Analysis: N=785 Assess smoking status between quit date and end of pregnancy

11. Reason why participants were excluded %n (total 2583) <1 cig/day now27.5710 Gestation >= 24 wks26.1673 Gestation < 10 wks8.0207 Unable to attend all visits13.9359 Wants to use NRT11.2290 Poor English5.8149 Drug or alcohol problem3.180 <10 cig before pregnancy2.153 Medical Contra-indication for exercise1.231 Age <160.717 Can’t walk for 15 mins0.513 No permission to contact GP/obstetrician0.031

12. Main behaviour change techniques used in PA consultations Discuss PA benefits/costs Explain/review effect of physical activity on cravings Review current PA & agree PA goals Demonstrate treadmill & pedometer & agree goals Provide PA and step-count diaries Explain exercises in booklet/DVD Provide information on places to exercise Identify barriers & problem solve Plan/review social support Michie S et al A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health 2011, 2:1479–1498.

13. Baseline CharacteristicsMean (SD) Age27.5 (6.5) years Gestation15.6 (3.3) weeks Cigarettes per day (now) Cigarettes per day (before pregnancy) 9.8 (5.5) 17.5 (5.1) Percentage Achieving 150 mins a week of moderate Intensity Physical Activity (mins)70%

14. Attendance at treatment sessions Group Mean number of sessions attended PA 5.2 of 14 sessions (37.4%) Control3.5 of 6 sessions (57.8%)

15. Main findings No significant difference in smoking abstinence at the end of pregnancy: physical activity group 7.7% control group 6.4% Changes in physical activity: PA group reported 34- 46% greater increases in PA than the control during the intervention period

16. Other key findings No significant effects on: smoking reduction, confidence for quitting, urges to smoke or withdrawal symptoms. Significantly higher confidence for PA in PA group. No significant benefit shown for reducing depression or maternal weight gain Adverse events & birth outcomes very similar in two groups except significantly less caesarean sections in PA group 60 participants (8%) used NRT during their pregnancy

17. Why wasn’t the intervention effective? Both groups highly active at baseline and still fairly active at end of pregnancy May be due to low attendance and failure to comply with goals of intervention

18. Main barriers to exercise adherence Based on focus groups with six research midwives: - Challenge of changing multiple health behaviours simultaneously - Poor psychological health, especially depression -Home life (e.g., domestic violence, frequently moving home) -Poor social networks -Pregnancy ailments (e.g. backache, fatigue) -Dropped out if relapsed

19. Facilitators to attendance and exercise adherence Professional support/midwife support Texting (Naughton F et al 2012 – Miquit) Financial incentives (Tappin, Bauld et al 2012 – CPIT ) Pedometers Choice of attendance in hospital or at community centre

20. Physical activity is not recommended for smoking cessation in pregnancy PA continues to be recommended for managing cigarette cravings and for general health benefits in pregnancy Conclusions