Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial
dc.contributor.author | Ussher, M | |
dc.contributor.author | Aveyard, P | |
dc.contributor.author | Manyonda, I | |
dc.contributor.author | Lewis, S | |
dc.contributor.author | West, R | |
dc.contributor.author | Lewis, B | |
dc.contributor.author | Marcus, B | |
dc.contributor.author | Taylor, Adrian | |
dc.contributor.author | Barton, P | |
dc.contributor.author | Coleman, T | |
dc.date.accessioned | 2016-08-24T15:46:35Z | |
dc.date.available | 2016-08-24T15:46:35Z | |
dc.date.issued | 2012-12 | |
dc.identifier.issn | 1745-6215 | |
dc.identifier.issn | 1745-6215 | |
dc.identifier.other | 186 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/5372 | |
dc.description.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. | |
dc.format.extent | 186- | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | eng | |
dc.publisher | Springer Science and Business Media LLC | |
dc.subject | Smoking cessation | |
dc.subject | Pregnancy | |
dc.subject | Physical activity | |
dc.subject | Intervention | |
dc.subject | Randomized controlled trial | |
dc.title | Physical activity as an aid to smoking cessation during pregnancy (LEAP) trial: study protocol for a randomized controlled trial | |
dc.type | journal-article | |
dc.type | Journal Article | |
dc.type | Multicenter Study | |
dc.type | Randomized Controlled Trial | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000312820800001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 1 | |
plymouth.volume | 13 | |
plymouth.publication-status | Published | |
plymouth.journal | Trials | |
dc.identifier.doi | 10.1186/1745-6215-13-186 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/FoH - Community and Primary Care | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Health and Community | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR) | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
plymouth.organisational-group | /Plymouth/Users by role/Researchers in ResearchFish submission | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2012-09-21 | |
dc.identifier.eissn | 1745-6215 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1186/1745-6215-13-186 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2012-10-04 | |
rioxxterms.type | Journal Article/Review |