Reducing tobacco smoke exposure in children aged below 4 years - a randomized controlled trial.

ABSTRACT

OBJECTIVE: To explore the reach of a German population-based household sample using proactive recruitment and to test the efficacy of a behavioral change counseling intervention including feedback about children's urine cotinine level (CUCL). METHODS: A randomized controlled trial (2008-2010) was conducted in households with at least one child aged below 4years and at least one current smoker. The study area comprised of 3570 households. A screening assessment was provided in 2641 households; 1282 included one current smoker and 852 completed the study protocol. The intervention group (IG; n=428) received feedback about CUCL and up to two counseling sessions. The control group (CG; n=424) received a leaflet. Assessments were provided at baseline and 12-month follow-up. Heckman's selection model analysis was used to consider the detection limit of cotinine in urine (10ng/ml). RESULTS: CUCL below the detection limit in the IG was found in 43.2% at baseline and 44.6% at follow-up and in 44.8% of the CG at baseline and 47.2% at follow-up. The CUCL difference between follow-up and baseline was smaller in the CG than in the IG. The effect was not significant. CONCLUSIONS: Data revealed a high reach of the target population but failed to identify an intervention effect. Clinical Trial Registration www.clinicaltrials.gov (NCT00647413).