Division of Population Health Sciences and Education, St George's University of London, Cranmer Terrace, London, SW17 ORE, UK.
Trials. 2012 Oct 4;13:186. doi: 10.1186/1745-6215-13-186.
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.
This trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.
ISRCTN48600346.
许多女性试图在怀孕期间戒烟，但都失败了。一个困难是，没有足够的证据表明戒烟药物在怀孕期间是有效和安全的，因此许多女性更愿意避免使用这些药物。体育活动（PA）干预措施可能有助于戒烟；然而，检查这些干预措施的试验规模太小，无法检测或排除合理的有益效果。伦敦运动与怀孕吸烟者（LEAP）试验正在研究 PA 干预措施是否对怀孕的吸烟者有效且具有成本效益，这将是迄今为止此类研究中规模最大的一次。
方法/设计：LEAP 研究是一项实用的、多中心的、两臂的、随机对照试验，将针对每天至少抽一支烟（怀孕前至少每天抽五支烟）且怀孕 10 至 24 周的孕妇进行。合格的患者被单独随机分配到常规护理组（即戒烟的行为支持）或常规护理加干预组（包括在跑步机上进行监督锻炼和 PA 咨询）。试验的主要结局是自我报告并通过生物化学验证的从指定戒烟日期到怀孕结束的连续戒烟。次要结局在戒烟日期后 1 周和 4 周以及怀孕结束时和产后 6 个月进行测量，包括 PA 水平、抑郁、自信和戒烟症状。产后 6 个月还将自我报告吸烟状况。此外，还将收集围产期措施，包括产前并发症、分娩时间、分娩方式以及出生体重和胎盘重量。将根据意向治疗原则分析结局，并使用逻辑回归模型比较治疗对主要结局的影响。
这项试验将评估 PA 干预措施在怀孕期间戒烟是否有效。
ISRCTN48600346。
