| Methods |
Country: Finland
Setting: community, well baby clinics
RCT |
| Participants |
1062 families presenting at a well baby clinic in Turku with a child 5 months old |
| Interventions |
Component of larger prospective intervention trial aimed at decreasing exposure of children to known environmental cardiovascular risk factors
Intervention: Parents received booklet about the adverse effects of smoking at age 5 years. Counselling from paediatrician and dietician consisted of discussion with parents about major cardiovascular risk factors including smoking. Appointment with paediatrician and dietician at 1‐ to 3‐monthly intervals until age 2 years, then 6 monthly
Control: normal health education given to all Finnish families at well baby clinics and throughout the school system. Appointment with paediatrician and dietician at 4‐ to 6‐monthly intervals until age 2 years, then 6‐monthly until age 7, then yearly |
| Outcomes |
Follow‐up when child 8 years of age:
• Parent report of smoking status and habits, reported child exposure to ETS in past 3 days
• Parent serum cotinine |
| Type of intervention |
Well‐child (child health check) |
| Notes |
Retention: 625/1062 (59%) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Random numbers"; further details not provided |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
High but similar dropout rates in both groups overall (serum cotinine measured in 306/540 intervention and 319/522 control). However, attrition of smokers not quantified and attrition analysis not reported. Trial authors write: "It is possible that smokers have discontinued participation in STRIP more frequently than non‐smokers". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Biochemical validation used |
