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. |
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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. |
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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. |