P60 Program Project Grant-Outreach for Smoke-Free Homes
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|ClinicalTrials.gov Identifier: NCT01574560|
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : August 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Tobacco Cessation||Behavioral: Brochure Behavioral: Counseling||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community Outreach and Biomarker Feedback for Smoke-Free Homes|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
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.
- Change in Home Secondhand Smoke levels [ Time Frame: From Baseline to Week 26 Follow-Up ]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 ]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 ]Measured by mediators and moderators of effect, including psychosocial and tobacco-related variables.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|