Donatelle 2000a.
Methods | Study design: RCT, conducted June 1996 to June 1997; data collection completed January 1998
Country: USA
Setting: 4 Oregon Women, Infants, and Children (WIC) programme sites SOS (Significant Other Supporter) Programme I |
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Participants | 220 women smokers (112 intervention, 108 control) Aged 15+, ≤ 28 weeks gestation, literate in English; withdrawal criteria included termination and foetal death | |
Interventions | All participants received a USD 5 participation voucher at each of 3 assessments. Everyone at baseline was given verbal and written advice on importance of smoking cessation by WIC‐ or SOS‐trained staff, + self‐help kit A pregnant woman’s guide to quit smoking Experimental Group(s): Each participant was asked to designate a social supporter, preferable female non‐smoker. Both were eligible for vouchers if participant quit. Participant was phoned monthly (up to 10 months) to report smoking status. If she reported quit and supplied confirmatory saliva sample, she got a USD 50 voucher, and “their social supporter received a voucher as well” (i.e. USD 50 for 1st quit month, USD 25 for other quit months, and USD 50 for final quit month). Vouchers were funded by contributions from 10 local 'community partners' (businesses, foundations and healthcare organisations) Control Group: Baseline advice and quit kit, + monthly phone calls to determine smoking status |
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Outcomes | 7‐day PPA at 8 months gestation, and at 2 months post‐partum Biochemical validation by salivary cotinine < 30 ng/ml, and salivary thiocyanate < 100 mg/ml |
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Notes | New for 2015 update Funding: grant from Robert Wood Johnson Foundation Smoke‐Free Families Program, + support from local businesses and healthcare facilities |
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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 |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstinence biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | High risk | Relatively high, but comparable with non‐participant attenders at the WIC clinic Losses: Intervention: 32% at 8 months gestation, 36% at 2 months post‐partum; Control: 51.5% at 8 months gestation, 52% at 2 months post‐partum |