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. Author manuscript; available in PMC: 2014 May 15.
Published in final edited form as: Cochrane Database Syst Rev. 2013 Oct 23;10:CD001055. doi: 10.1002/14651858.CD001055.pub4
Methods Randomised controlled trial evaluating provision of videotaped vignettes for promoting smoking cessation and relapse prevention during pregnancy
Study conducted in a community-based university setting, Texas, USA. Data collection dates not reported
Participants Inclusion criteria: Volunteers who were willing to quit within 2 weeks.
Exclusion criteria: Women smoking < 3 cigarettes per day; < 18 years; > 30 weeks’ pregnant; do not have a working video recorder (approximately 12% Americans); depressed
Recruitment: Through local media, such as newspaper, radio, subscriber letters, community business flyers, waiting room posters
146 women screened and 82 women who met inclusion criteria were randomised (C = 40, I = 42)
Baseline characteristics: Mean cigarettes/day at first visit: C = 14.5, I = 17.3.
Progress+ coding: None.
Interventions Control: Received a quit calendar and tip guide.
Intervention: As for control plus were mailed a video with 6 × 25-30 minute vignettes covering a range of topics and strategies from initial quitting to relapse prevention
Main intervention strategy: Counselling (single intervention) compared to a less intensive intervention
Intensity: Frequency (C = 2, I = 2), Duration (C = 1, I = 4).
Intervention provided by study staff: efficacy study.
Outcomes Biochemically validated point prevalence abstinence obtained within 2-3 days of quit date, 4-5 weeks after the quit date (late pregnancy)* and 1 month postpartum (0-5 months postpartum*).
Participant evaluation of intervention materials.
Associated references report association of quitting and depressive disorders. CES-D scores at baseline only
Notes Authors say women in this study tend to be heavier smokers than described in previous studies
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated.
Allocation concealment (selection bias) Unclear risk Not stated.
Incomplete outcome data (attrition bias)
All outcomes
Low risk Only 61% of participants completed all assessments. All those with missing data were treated as continuing smokers in this review
Selective reporting (reporting bias) Low risk Pre-specified outcomes reported.
Other bias Low risk No other bias detected.
Biochemical validation of smoking abstinence (detection bias) Low risk All reports of abstinence were validated by measurement of salivary cotinine
Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk Video mailed to participants. Not clear if UC givers were aware of group allocation
Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk Not reported.
Incomplete implementation High risk Process evaluation showed only 53% of the intervention group viewed 1-3 of the 6 videos. 47% did not view them
Equal baseline characteristics in study arms Low risk No significant difference in socioeconomic variables between groups
Contamination of control group Low risk Video mailed out to participants only.