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. 2017 Feb 14;2017(2):CD001055. doi: 10.1002/14651858.CD001055.pub5

Wilkinson 2012.

Methods Randomised controlled trial of the dietitian‐led behaviour change 'Healthy start to pregnancy' (HSP) workshop. The study was conducted in a tertiary Maternal Health service in South East Queensland, Australia between 31 August 2010 and 7 March 2011.
Participants Inclusion criteria: Women > 18 (or < 18 with parental consent) attending their booked visit at the Maternal Health research site
Exclusion criteria: Women were excluded if they were unable to read and speak English at a level that allowed completion of pen‐and‐paper survey.
Recruitment: 882 approached, 360 randomised (60 smokers), 178 to intervention (29 smokers) and 182 to control (31 smokers)
Baseline characteristics: Unable to determine baseline characteristics of smokers as just a small subset of a larger nutritional intervention.
Interventions Control: Usual nutrition care through the Maternal Health provider.
Intervention: A 60‐min 'healthy start to pregnancy', which included a smoking component based on the 5 A's and aimed to influence behaviours with demonstrated health outcomes.
Main Intervention strategy: Maternal health intervention with smoking cessation component: Counselling (single) vs UC
Intensity: Frequency: (C = 0, I = 2); Duration: (C = 0, I = 3).
Progress + coding: None as unable to determine characteristics of subgroup of smokers.
Outcomes Self‐reported not smoking at 12 weeks*, Intention to breastfeed, diet quality index, weekly mins of physical activity.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The computerised randomisation process was managed by the research hospitals clinical research support unit.
Allocation concealment (selection bias) Low risk Group allocation was concealed using sealed opaque envelopes.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk ITT analysis was used.
Selective reporting (reporting bias) Low risk All primary outcomes reported.
Other bias Low risk No other bias detected.
Biochemical validation of smoking abstinence (detection bias) High risk Smoking was not biochemically validated, just self‐report.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not specified but not practical to blind women and providers to educational intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All outcomes were self‐report.
Incomplete implementation Unclear risk Unclear as only a subset of participants were smokers.
Equal baseline characteristics in study arms Unclear risk Characteristics of smokers can not be determined as part of a broader maternal health intervention.
Contamination of control group Low risk Intervention was a health promotion workshop which control individuals did not attend.