Abstract
BackgroundMany 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/designThe 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.DiscussionThis trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.Trial registrationISRCTN48600346
Highlights
Many women try to stop smoking in pregnancy but fail
This trial will assess whether a Physical activity (PA) intervention is effective when used for smoking cessation during pregnancy
Aim The aim of this paper is to describe the protocol for an Randomized controlled trial (RCT) designed to evaluate an intervention for increasing PA as an aid for smoking cessation during pregnancy
Summary
Maternal smoking during pregnancy is the major preventable cause of poor health outcomes for women and their babies. Six adequately powered trials compared a group receiving a PA intervention as an adjunct to behavioral support with a group receiving behavioral support alone Three of these studies showed significantly higher smoking abstinence rates in a physically active group versus a control group at end of treatment [20,21,22]. A further study showed significantly higher abstinence rates for the exercise group compared with control group at the 3-month follow-up, but not at the end of treatment or at the 12-month follow-up [23]. A more intensive intervention entailed 22 women receiving 9 weeks of individual smoking cessation support, plus 15 sessions of supervised exercise (brisk treadmill walk or stationary cycling) and PA consultations. Aim The aim of this paper is to describe the protocol for an RCT designed to evaluate an intervention for increasing PA as an aid for smoking cessation during pregnancy
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