Sabina Ulbricht1, Stefan Groß2, Christian Meyer3, Wolfgang Hannöver4, Matthias Nauck5, Ulrich John6. 1. Institute of Social Medicine and Prevention, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany. Electronic address: ulbricht@uni-greifswald.de. 2. Department for Internal Medicine B, University Medicine Greifswald, Sauerbruchstr., 17475 Greifswald, Germany. Electronic address: stefan.gross1@uni-greifswald.de. 3. Institute of Social Medicine and Prevention, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany. Electronic address: chmeyer@uni-greifswald.de. 4. Institute for Medical Psychology, University Medicine Greifswald, Walther-Rathenau-Str. 46, 17475 Greifswald, Germany. Electronic address: hannoeve@uni-greifswald.de. 5. Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Sauerbruchstr., 17475 Greifswald, Germany. Electronic address: matthias.nauck@uni-greifswald.de. 6. Institute of Social Medicine and Prevention, University Medicine Greifswald, Walther-Rathenau-Str. 48, D-17475 Greifswald, Germany. Electronic address: ujohn@uni-greifswald.de.
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).
RCT Entities:
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).