Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01726062|
Recruitment Status : Recruiting
First Posted : November 14, 2012
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Exposure to Secondhand Smoke in Neonatal Infants||Behavioral: Motivational Interviewing plus Incentives Behavioral: Conventional Care (CC)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2017|
|Experimental: Motivational Interviewing plus Incentives||
Behavioral: Motivational Interviewing plus Incentives
|Conventional Care (CC)||
Behavioral: Conventional Care (CC)
Participants in this arm will receive brochures and a brief information meeting in the NICU.
- Infant Second-Hand Smoke Exposure via Urine Cotinine [ Time Frame: Follow-up visit 4 months post-treatment ]Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.
- Secondhand Smoke Exposure outcomes [ Time Frame: Change from Baseline to the 4 months post-treatment followup ]Primary caregiver reports via the Timeline Follow-Back and household air nicotine monitors. Number of cigarettes smoked outdoors vs. indoor and the implementation of household smoking bans will also be assessed. Primary caregivers will complete the SHSe related interviews and self-report questionnaires. Primary caregivers who are smokers will complete measures related to smoking and smoking cessation.
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): NCT01726062
|Contact: Angela L Stotts, PhD||7135007590||Angela.L.Stotts@uth.tmc.edu|
|Contact: Thomas F Northrup, PhD||7135007590||Thomas.F.Northrup@uth.tmc.edu|
|United States, Texas|
|Children's Memorial Hermann Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Angela L Stotts, PhD|
|Principal Investigator:||Angela Stotts, PhD||University of Texas at Houston Family and Community Medicine|