- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01634334
Improving Household Air Quality in Homes With Children (ProjFreshAir)
April 13, 2016 updated by: Melbourne Hovell, San Diego State University
Innovation for Smoke-Free Homes: Real-Time Feedback
The purpose of this study is to determine if real-time feedback (lights/sounds) from small smoke particle monitors and brief coaching will encourage parents to reduce young children's secondhand tobacco smoke exposure in their home.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this efficacy study is to test whether children's home secondhand tobacco smoke exposure (measured by cotinine & nicotine assays, fine particulates and reports of smoking in the home and/or home smoking bans) can be reduced by using custom particle monitors to provide real-time feedback to household residents plus brief advice/praise.
Study Type
Interventional
Enrollment (Actual)
298
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Diego, California, United States, 92123
- SDSU - Center for Behavioral Epidemiology and Community Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Families with at least one parent or guardian (18 years of age or older),
- Household resident who smokes tobacco,
- Child under fourteen years old exposed to tobacco smoking in the home
- Plans to live in San Diego County for at least three months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real-time Intervention
|
Lights and Sound Brief Coaching
|
|
Active Comparator: Usual Education
Participants will receive usual education about secondhand and thirdhand smoke.
|
Participants will receive usual education about secondhand smoke and thirdhand smoke.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondhand Smoke Reduction
Time Frame: Measured from baseline upto 5 months
|
Parental report and child urine cotinine.
|
Measured from baseline upto 5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Home Smoking Ban
Time Frame: Measured from baseline upto 5 months.
|
Parental report of home smoking ban and environmental data collection.
|
Measured from baseline upto 5 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melbourne F Hovell, PhD, MPH, SDSU - Center for Behavioral Epidemiology and Community Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hovell MF, Bellettiere J, Liles S, Nguyen B, Berardi V, Johnson C, Matt GE, Malone J, Boman-Davis MC, Quintana PJE, Obayashi S, Chatfield D, Robinson R, Blumberg EJ, Ongkeko WM, Klepeis NE, Hughes SC; Fresh Air Research Group. Randomised controlled trial of real-time feedback and brief coaching to reduce indoor smoking. Tob Control. 2020 Mar;29(2):183-190. doi: 10.1136/tobaccocontrol-2018-054717. Epub 2019 Feb 15.
- Hughes SC, Bellettiere J, Nguyen B, Liles S, Klepeis NE, Quintana PJE, Berardi V, Obayashi S, Bradley S, Hofstetter CR, Hovell MF. Randomized Trial to Reduce Air Particle Levels in Homes of Smokers and Children. Am J Prev Med. 2018 Mar;54(3):359-367. doi: 10.1016/j.amepre.2017.10.017. Epub 2018 Jan 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
July 2, 2012
First Submitted That Met QC Criteria
July 5, 2012
First Posted (Estimate)
July 6, 2012
Study Record Updates
Last Update Posted (Estimate)
April 14, 2016
Last Update Submitted That Met QC Criteria
April 13, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HL103684 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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