title: 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).
authors.affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany. Electronic address: ulbricht@uni-greifswald.de.
authors.forename: Sabina
authors.initials: S
authors.lastname: Ulbricht
authors.affiliation: Department for Internal Medicine B, University Medicine Greifswald, Sauerbruchstr., 17475 Greifswald, Germany. Electronic address: stefan.gross1@uni-greifswald.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Groß
authors.affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany. Electronic address: chmeyer@uni-greifswald.de.
authors.forename: Christian
authors.initials: C
authors.lastname: Meyer
authors.affiliation: Institute for Medical Psychology, University Medicine Greifswald, Walther-Rathenau-Str. 46, 17475 Greifswald, Germany. Electronic address: hannoeve@uni-greifswald.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hannöver
authors.affiliation: Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Sauerbruchstr., 17475 Greifswald, Germany. Electronic address: matthias.nauck@uni-greifswald.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Nauck
authors.affiliation: Institute of Social Medicine and Prevention, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany. Electronic address: ujohn@uni-greifswald.de.
authors.forename: Ulrich
authors.initials: U
authors.lastname: John
mesh_terms: D000328:Adult; D001521:Behavior Therapy / Q000379:methods; D002675:Child, Preschool; D003367:Cotinine / Q000652:urine*; D003376:Counseling / Q000379:methods* / Q000706:statistics & numerical data; D004781:Environmental Exposure / Q000032:analysis* / Q000517:prevention & control; D005260:Female; D005858:Germany; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D010290:Parents; D015397:Program Evaluation; D012907:Smoking / Q000652:urine*; D016540:Smoking Cessation; D000074606:Smoking Prevention; D013689:Telephone; D014028:Tobacco Smoke Pollution / Q000032:analysis* / Q000517:prevention & control; D055815:Young Adult
chemical_list: D014028:Tobacco Smoke Pollution; D003367:Cotinine
keywords: Children; Cotinine; Counseling; Environmental tobacco smoke; Intervention; RE-AIM; Reach; Smoking