Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2012

Open Access 01-12-2012 | Study protocol

Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial

Authors: Michael Ussher, Paul Aveyard, Isaac Manyonda, Sarah Lewis, Robert West, Beth Lewis, Bess Marcus, Adrian H Taylor, Pelham Barton, Tim Coleman

Published in: Trials | Issue 1/2012

Login to get access

Abstract

Background

Many women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date.

Methods/design

The LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome.

Discussion

This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.

Trial registration

ISRCTN48600346
Appendix
Available only for authorised users
Literature
1.
Batstra L, Hadders-Algra M, Neeleman J: Effect of antenatal exposure to maternal smoking on behavioural problems and academic achievement in childhood: prospective evidence from a Dutch birth cohort. Early Hum Dev. 2003, 75: 21-33.CrossRefPubMed
2.
Cnattingius S: The epidemiology of smoking during pregnancy: smoking prevalence, maternal characteristics, and pregnancy outcomes. Nicotine Tob Res. 2004, 6 (Suppl 2): 125-140.CrossRef
3.
Charlton A: Children and smoking: the family circle. Brit Med Bull. 1996, 52: 90-107. 10.1093/oxfordjournals.bmb.a011535.CrossRefPubMed
4.
Royal College of Physicians: Smoking and the young. A report of a working party of the Royal College of Physicians. 1992, London: RCP
5.
Wideroe M, Vik T, Jacobsen G, Bakketeig LS: Does maternal smoking during pregnancy cause childhood overweight?. Paediat Perinat Epidemiol. 2003, 17: 171-179. 10.1046/j.1365-3016.2003.00481.x.CrossRef
6.
Munafò MR, Heron J, Araya R: Smoking patterns during pregnancy and postnatal period and depressive symptoms. Nicotine Tob Res. 2008, 10: 1609-1620. 10.1080/14622200802412895.CrossRefPubMed
7.
Toivonen S, Heinonen S, Anttila M, Kosma VM, Saarikoski S: Reproductive risk factors, Doppler findings, and outcome of affected births in placental abruption: a population-based analysis. Am J Perinatol. 2002, 19: 451-456. 10.1055/s-2002-36868.CrossRefPubMed
8.
9.
10.
Shipton D, Tappin DM, Vadiveloo T, Crossley JA, Aitken DA, Chalmers J: Reliability of self reported smoking status by pregnant women for estimating smoking prevalence: a retrospective, cross sectional study. BMJ. 2009, 339: b4347-10.1136/bmj.b4347.CrossRefPubMedPubMedCentral
11.
Owen L, Penn G: Smoking and pregnancy: A survey of knowledge attitudes and behaviour, 1992–1999. 1999, London: Health Development Agency
12.
Cahill K, Stead LF, Lancaster T: Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2011, 2: CD006103-PubMed
13.
Hughes JR, Stead LF, Lancaster T: Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2007, 1: CD000031-PubMed
14.
Stead LF, Perera R, Bullen C, Mant D, Lancaster T: Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2008, 1: CD000146-PubMed
15.
Coleman T, Chamberlain C, Cooper S, Leonardi-Bee J: Efficacy and safety of nicotine replacement therapy for smoking cessation in pregnancy: systematic review and meta-analysis. Addiction. 2011, 106: 52-61. 10.1111/j.1360-0443.2010.03179.x.CrossRefPubMed
16.
17.
National Institute for Health and Clinical Excellence: NICE public health guidance 26: How to stop smoking in pregnancy and following childbirth. 2010, London: NICE
18.
Lumley J, Chamberlain C, Dowswell T, Oliver S, Oakley L, Watson L: Interventions for promoting smoking cessation during Pregnancy. Cochrane Database Syst Rev. 2009, 3: CD001055-PubMed
19.
Ussher MH, Taylor A, Faulkner G: Exercise interventions for smoking cessation. Cochrane Database Syst Rev. 2012, 1: CD002295-PubMed
20.
Marcus BH, Albrecht AE, King TK, Parisi AF, Pinto BM, Roberts M, Niaura RS, Abrams DB: The efficacy of exercise as an aid for smoking cessation in women: A randomised controlled trial. Arch Intern Med. 1999, 159: 1229-1234. 10.1001/archinte.159.11.1229.CrossRefPubMed
21.
Marcus BH, Albrecht AE, Niaura RS, Abrams DB, Thompson PD: Usefulness of physical exercise for maintaining smoking cessation in women. Am J Cardiol. 1991, 68: 406-407. 10.1016/0002-9149(91)90843-A.CrossRefPubMed
22.
Martin JE, Kalfas KJ, Patten CA, Polarek M, Hofstetter CR, Noto J, Beach D: Prospective evaluation of three smoking interventions in 205 recovering alcoholics: One-year results of project SCRAP-Tobacco. J Consult Clin Psychol. 1997, 65: 190-194.CrossRefPubMed
23.
Marcus BH, Lewis BA, Hogan J, King TK, Albrecht AE, Bock B, Parisi AF, Niaura R, Abrams DB: The efficacy of moderate-intensity exercise as an aid for smoking cessation in women: a randomized controlled trial. Nicotine Tob Res. 2005, 7: 871-880. 10.1080/14622200500266056.CrossRefPubMed
24.
American College of Obstetricians and Gynecologists: Exercise during pregnancy and the postpartum period. Obstet Gynecol. 2003, 46: 496-499.
25.
26.
Pomerleau CS, Brouwer RJ, Jones LT: Weight concerns in women smokers during pregnancy and postpartum. Addict Behav. 2000, 25: 759-767. 10.1016/S0306-4603(00)00086-1.CrossRefPubMed
27.
Ussher M, West R, Hibbs N: A survey of pregnant smokers' interest in different types of smoking cessation support. Patient Educ Couns. 2004, 54: 67-72. 10.1016/S0738-3991(03)00197-6.CrossRefPubMed
28.
Ussher M, Aveyard P, Coleman T, Straus L, West R, Marcus B, Lewis B, Manyonda I: Physical activity as an aid to smoking cessation during pregnancy: two feasibility studies. BMC Public Health. 2008, 8: 328-10.1186/1471-2458-8-328.CrossRefPubMedPubMedCentral
29.
30.
Thomas S, Reading J, Shepard RJ: Revision of the physical activity readiness questionnaire. Can J Sport Sci. 1992, 17: 338-345.PubMed
31.
Coleman T, Cooper S, Thornton JG, Grainge MJ, Watts K, Britton J, Lewis S: A randomized trial of nicotine-replacement therapy patches in pregnancy. N Engl J Med. 2012, 366: 808-818. 10.1056/NEJMoa1109582.CrossRefPubMed
32.
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008, 148: 295-309.CrossRefPubMed
33.
Davidson KW, Goldstein M, Kaplan RM, Kaufmann PG, Knatterund GL, Orleans CT, Spring B, Trudeau KJ, Whitlock EP: Evidence-based behavioural medicine: what is it and how do we achieve it?. Ann Behav Med. 2003, 26: 161-171. 10.1207/S15324796ABM2603_01.CrossRefPubMed
34.
Bandura A: Health promotion by social cognitive means. Health Educ Behav. 2004, 31: 143-10.1177/1090198104263660.CrossRefPubMed
35.
Michie S, Hyder N, Walia A, West R: Development of a taxonomy of behaviour change techniques used in individual behavioural support for smoking cessation. Addict Behav. 2011, 36: 315-319. 10.1016/j.addbeh.2010.11.016.CrossRefPubMed
36.
NHS Centre for Smoking Cessation and Training: NCSCT Training Standard: Learning Outcomes for Training Stop Smoking Practitioners. 2010, NHS, London
37.
Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP: 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.CrossRef
38.
Mottola MF, Davenport MH, Brun CR, Inglis SD, Charlesworth S, Sopper MM: VO2 peak prediction and exercise prescription for pregnant women. Med Sci Sport Exer. 2006, 38: 1389-1395. 10.1249/01.mss.0000228940.09411.9c.CrossRef
39.
Borg GAV: Borg’s Perceived Exertion and Pain Scales. Champaign. 1998, Illinois: Human Kinetics
40.
Taylor AH, Ussher MH, Faulkner G: The acute effects of exercise on cigarette cravings, withdrawal symptoms, affect and smoking behaviour: a systematic review. Addiction. 2007, 102: 534-543. 10.1111/j.1360-0443.2006.01739.x.CrossRefPubMed
41.
Rodriguez A, Bohlin G, Lindmark G: Psychosocial predictors of smoking and exercise during pregnancy. J Reprod Infant Psyc. 2000, 18: 203-233. 10.1080/713683039.CrossRef
42.
Rooney B, Smalley K, Larson J, Havens S: Is knowing enough? Increasing physical activity by wearing a pedometer. Wisconsin Med J. 2003, 102: 31-36.
43.
Downs DS, LeMasurier GC, DiNallo JM: Baby steps: pedometer-determined and self-reported leisure-time exercise behaviors of pregnant women. J Phys Act Health. 2009, 6: 63-72.PubMed
44.
Prochaska JJ, Hall SM, Humfleet G, Munoz RF, Reus V, Gorecki J, Hu D: Physical activity as a strategy for maintaining tobacco abstinence: a randomized trial. Prev Med. 2008, 47: 215-220. 10.1016/j.ypmed.2008.05.006.CrossRefPubMedPubMedCentral
45.
West R, Russell M: Pre-abstinence smoke intake and smoking motivation as predictors of severity of cigarette withdrawal symptoms. Psychopharmacology. 1985, 87: 334-336. 10.1007/BF00432717.CrossRefPubMed
46.
West R, Hajek P: Evaluation of the Mood and Physical Symptoms Scale (MPSS) to assess cigarette withdrawal. Psychopharmacology. 2004, 177: 195-199. 10.1007/s00213-004-1923-6.CrossRefPubMed
47.
Heatherton T, Kozlowski L, Frecker T, Fagerström K: The Fagerström Test for Nicotine Dependence: a revision of the Fagerström Tolerance Questionnaire. Brit J Addict. 1991, 86: 1119-1127. 10.1111/j.1360-0443.1991.tb01879.x.CrossRef
48.
Murray D, Cox JL: Screening for depression during pregnancy with the Edinburgh Depression Scale (EPDS). J Reprod Infant Psyc. 1990, 8: 99-107. 10.1080/02646839008403615.CrossRef
49.
Blair SN, Haskell WL, Ho P, Paffenbarger P, Vranizan KM, Farquhar JW, Wood PD: Assessment of habitual physical activity by seven-day recall in a community survey and controlled experiments. Am J Epidemiol. 1985, 122: 794-804.PubMed
50.
Marcus BH, Selby VC, Niaura RS, Rossi JS: Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport. 1992, 63: 60-66.CrossRefPubMed
51.
West R, Willis N: Double-blind placebo controlled trial of dextrose tablets and nicotine patch in smoking cessation. Psychopharmacology. 1998, 136: 201-204. 10.1007/s002130050557.CrossRefPubMed
52.
Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE: Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003, 5: 13-25.CrossRefPubMed
53.
West R, Hajek P, Stead L, Stapleton J: Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction. 2005, 100: 299-303. 10.1111/j.1360-0443.2004.00995.x.CrossRefPubMed
54.
SRNT Subcommittee on Biochemical Verification: Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002, 4: 149-159. 10.1080/14622200210123581.CrossRef
55.
Etzel RA: A review of the use of saliva cotinine as a marker of tobacco smoke exposure. Prev Med. 1990, 19: 190-197. 10.1016/0091-7435(90)90020-K.CrossRefPubMed
56.
Windsor RA, Orleans CT: Guidelines and methodological standards for smoking cessation intervention research among pregnant women: improving the science and art. Health Educ Q. 1986, 13: 131-161. 10.1177/109019818601300203.CrossRefPubMed
57.
Malchodi CS, Oncken C, Dornelas EA, Caramanica L, Gregonis E, Curry SL: The effects of peer counseling on smoking cessation and reduction. Obstet Gynecol. 2003, 101: 504-510. 10.1016/S0029-7844(02)03070-3.PubMed
58.
Windsor RA, Li CQ, Boyd NR, Hartmann KE: The use of significant reduction rates to evaluate health education methods for pregnant smokers: a new harm reduction behavioral indicator?. Health Educ Behav. 1999, 26: 648-662. 10.1177/109019819902600506.CrossRefPubMed
59.
Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS: Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sport Exerc. 2004, 36: 1750-1760. 10.1249/01.MSS.0000142303.49306.0D.CrossRef
60.
DiNallo JM, Downs DS, Le Masurier G: Objectively assessing treadmill walking during the second and third pregnancy trimesters. J Phys Act Health. 2012, 9: 21-28.PubMed
61.
Rousham EK, Clarke PE, Gross H: Significant changes in physical activity among pregnant women in the UK as assessed by accelerometry and self-reported activity. Eur J Clin Nutr. 2006, 60: 393-400. 10.1038/sj.ejcn.1602329.CrossRefPubMed
62.
Etter JF, Stapleton JA: Nicotine replacement therapy for long-term smoking cessation: a meta-analysis. Tob Control. 2006, 15: 280-285. 10.1136/tc.2005.015487.CrossRefPubMedPubMedCentral
63.
Stapleton J: Cigarette smoking prevalence, cessation and relapse. Stat Methods Med Res. 1998, 7: 187-203. 10.1191/096228098671391775.CrossRefPubMed
64.
MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V: A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002, 7: 83-104.CrossRefPubMedPubMedCentral
65.
Lawrence T, Aveyard P, Croghan E: What happens to women's self-reported cigarette consumption and urinary cotinine levels in pregnancy?. Addiction. 2003, 98: 1315-1320. 10.1046/j.1360-0443.2003.00485.x.CrossRefPubMed
Metadata
Title
Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial
Authors
Michael Ussher
Paul Aveyard
Isaac Manyonda
Sarah Lewis
Robert West
Beth Lewis
Bess Marcus
Adrian H Taylor
Pelham Barton
Tim Coleman
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-13-186

Other articles of this Issue 1/2012

Trials 1/2012 Go to the issue

Study protocol

Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Research

The Patient Deficit Model Overturned: a qualitative study of patients' perceptions of invitation to participate in a randomized controlled trial comparing selective bladder preservation against surgery in muscle invasive bladder cancer (SPARE, CRUK/07/011)

Study protocol

Assessing the effectiveness of ‘pulse radiofrequency treatment of dorsal root ganglion’ in patients with chronic lumbar radicular pain: study protocol for a randomized control trial

Study protocol

UK Dermatology Clinical Trials Network’s STOP GAP trial (a multicentre trial of prednisolone versus ciclosporin for pyoderma gangrenosum): protocol for a randomised controlled trial

Study protocol

Health-related quality of life in cancer patients at the end of life, translation, validation, and longitudinal analysis of specific tools: study protocol for a randomized controlled trial

Study protocol

Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial