Cummins 2016b.
Methods | Setting: California USA; pregnant women Recruitment: Callers to University of California San Diego California Smokers' Helpline |
|
Participants | 1173 pregnant (< 27 weeks) women, willing to quit within 1 month or recent quitters, av. age 26.3, av. cigs/day 11.2 | |
Interventions | 1. Self‐help American Cancer Society's Make Yours a Fresh Start Family fact sheets, and additional tips for quitting while pregnant 2. As 1, plus proactive TC specifically developed for pregnant smokers, including 9 x 30 ‐ 45‐min sessions on days 0, 1, 3, 7, 14, and 30 after quit date, at 32 weeks of gestation, and 2 and 4 weeks after delivery | |
Outcomes | Abstinence at 6 m post‐partum (180‐day abstinence) Validation: saliva cotinine < 13 ng/mL | |
Notes | New for 2018 update. Previously listed under studies awaiting assignment as Zhu 2004 Funding: "This research was supported by the Tobacco‐Related Disease Research Program (Grant 8RT‐0103) and First 5 California (Contract CCFC‐6810) and by funds received from the California Department of Health Services Tobacco Control Section (Contract 00–90605)." Declarations of interest: none declared |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Random allocation to condition was done by computer using blocks of 20" |
Allocation concealment (selection bias) | Low risk | Quote: "staff were blind to group assignment until the end of the intake, when the appropriate script was presented" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Higher % lost to follow‐up in intervention arm |