P60 Program Project Grant-Outreach for Smoke-Free Homes
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Community Outreach and Biomarker Feedback for Smoke-Free Homes|
- Change in Home Secondhand Smoke levels [ Time Frame: From Baseline to Week 26 Follow-Up ] [ Designated as safety issue: No ]Measured by nicotine dosimeter - a passive "badge" hung in the home that measures free floating airborne nicotine particles.
- Comparison of Child Cotinine Levels in Urine [ Time Frame: From Baseline to Week 26 Follow-Up ] [ Designated as safety issue: No ]Cotinine is an alkaloid found in tobacco and is also a metabolite of nicotine. Cotinine is used as a biomarker for exposure to tobacco smoke. Child (non-smoker) cotinine will be used as an objective measure of secondhand smoke exposure at baseline and again at end of study (week 26).
- Comparison of Questionnaire Results [ Time Frame: Baseline, Week 16 and Week 26 ] [ Designated as safety issue: No ]Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.
|Study Start Date:||January 2011|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Control Group - Health Education
This group is provided with information regarding secondhand smoke and creating a healthy home environment.
Information regarding secondhand smoke and creating a healthy home environment.
Active Comparator: Treatment Group - Counseling
This group is provided with biomarker feedback on child exposure to secondhand smoke. Active participants receive 5 counseling sessions from a trained research counselor; 3 sessions in the home and 2 by phone. The counseling sessions focus on changing smoking behaviors and/or other behaviors that impact smoking.
Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.
This study will be conducted in two phases. Phase 1 will be qualitative focus groups/pilot study with the purpose to develop a motivationally enhanced biomarker feedback counseling protocol and all printed materials to be used in Phase 2. After investigators develop a good working treatment protocol, an active intervention in smoking homes who live with a child in their home will be carried out.
Those randomized to the Control Group will receive health education in the form of brochures detailing the health effects of secondhand smoke and how to make their home smoke free. Participants randomized to the Treatment Group will receive tobacco-specific biomarker feedback and personalized motivationally enhanced counseling.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01574560
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Janet L. Thomas, Ph.D.||Masonic Cancer Center, University of Minnesota|