Mauriello 2013.
Methods | This single‐blind 2‐armed randomised controlled trial of the (Healthy Pregnancy: Step by Step) is a broad maternal and child health program which aims to address smoking cessation, stress management, and fruit and vegetable consumption in pregnant women. The study was conducted in Connecticut, Rhode Island and New York in the USA from December 2011 to September 2012. | |
Participants |
Inclusion criteria: > 18 years, English or Spanish speaking, and less than 19 weeks' gestation. Exclusion criteria: Not stated. Recruitment: Prenatal health staff at each participating location invited all pregnant women who met the eligibility requirements to participate. 392 women were approached, with 117 smokers randomised (C = 60 I = 57). Baseline characteristics: Characteristics of smokers at baseline not reported. Progress + coding: None. |
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Interventions |
Control: The UC arm received a 'March of Dimes' brochure on the target behaviours at the conclusion of their first assessment. Intervention: To test an iPad‐delivered multiple behaviour tailored intervention for pregnant women that addresses smoking cessation, stress management and fruit and vegetable consumption. Main Intervention strategy: Maternal Health intervention with smoking cessation component: Health education (single) vs UC. Intensity: Frequency (C = 0 I = 3) Duration (C = 0 I = 3). |
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Outcomes | Smoking outcomes not reported as authors state numbers were too small. Fruit and vegetable consumption and stress management reported. See Table 4 for summary of reported results. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A randomised 2 x 2 factorial repeated measures design was employed with randomisation on the individual level stratified on behaviour risk. |
Allocation concealment (selection bias) | Unclear risk | States that computer allocation was used so assume concealed from researchers. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Smoking outcomes not reported as numbers were too small. |
Selective reporting (reporting bias) | Unclear risk | Smoking outcomes not reported as numbers were too small. |
Other bias | Unclear risk | No other bias detected. |
Biochemical validation of smoking abstinence (detection bias) | High risk | No evidence of validation is reported and no smoking outcomes reported. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear as smoking was not assessed. |
Incomplete implementation | Low risk | Process evaluation not undertaken. |
Equal baseline characteristics in study arms | Unclear risk | Baseline characteristics appear to be equal. |
Contamination of control group | Low risk | Intervention was self‐administered via an iPad application, so no likelihood of contamination. |