Harris 2015.
Methods | A 2‐armed single randomised controlled trial of a web‐based contingency management program; Motiv8. This study was conducted in Rural Appalachia, Ohio and Kentucky on a community sample of pregnant smokers, recruited from prenatal clinics. | |
Participants |
Inclusion criteria: Adults aged 18 years and older, daily smokers (reporting smoking at least 2 cigarettes per day verified by breath CO readings and urinary cotinine levels), and were <= 12 weeks pregnant Exclusion criteria: Not stated. Recruitment: 47% participation rate (C = 10 I = 7). Baseline characteristics: Nicotine dependence (modified Fagerstroms test) (C = 4.90 I = 5.71), Cigarettes per day (C = 13.69 I = 9.45) Mean Age (C = 24.20 I = 24.00). Progress + coding: Low SES. |
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Interventions |
Control: Intensive phone delivered cessation counselling program based on Smoking Cessation for Healthy Births (SCHB). Intervention: The Motiv8 program lasted 6 weeks and consisted of 5 phases: Baseline (7 days), Shaping (4 days), Abstinence (21 days), Thinning (5 days), and Return to Baseline (5 days). During each phase, participants submitted video recordings of themselves twice per day (at least 8 hours apart) giving breath samples using the Smokerlyzer. They could earn vouchers exchangeable for online purchases with major retailers (e.g. Best Buy, Wal‐Mart) for criterion breath samples based on program phase. For the Abstinence phase, participants were required to have breath CO levels <= 4 ppm. Main Intervention strategy: Incentives (single) v alternative Intervention Intensity: Frequency (C = 4, I = 6) Duration (C = 4, I = 4). Intervention provided by study staff: efficacy study |
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Outcomes | Biochemically validated smoking abstinence in late pregnancy*, Smoking reduction by 50% urine cotinine levels* | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Reporting smoking at least 2 cigarettes per day verified by breath CO readings and urinary cotinine levels |
Allocation concealment (selection bias) | Low risk | As randomisation was done by computer, allocation of participant to control or intervention would have been concealed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Any missing data were coded as non abstinent/reduction. |
Selective reporting (reporting bias) | Low risk | All outcomes are reported. |
Other bias | Low risk | No other bias detected. |
Biochemical validation of smoking abstinence (detection bias) | Low risk | Smoking was biochemically validated by breath CO levels <= 4 ppm and urinary cotinine levels. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding did not seem to occur as physician and participant would know which arm of the trial they were in. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | This was not described. |
Incomplete implementation | High risk | Only 68% of intervention participants provided the required breath samples at follow‐up and in control, phone counsellors provided on average 3.9 of the required 5 phone calls. |
Equal baseline characteristics in study arms | Low risk | Baseline characteristics in both arms appear equal. |
Contamination of control group | Low risk | Intervention and control were either delivered via the web or mobile phone so contamination very unlikely. |