Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Improving Household Air Quality in Homes With Children (ProjFreshAir)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by San Diego State University
Information provided by (Responsible Party):
Melbourne Hovell, San Diego State University Identifier:
First received: July 2, 2012
Last updated: June 24, 2014
Last verified: June 2014

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.

Condition Intervention
Lung Diseases
Behavioral: Real-Time Intervention
Behavioral: Usual Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Innovation for Smoke-Free Homes: Real-Time Feedback

Resource links provided by NLM:

Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Secondhand Smoke Reduction [ Time Frame: Measured from baseline upto 5 months ] [ Designated as safety issue: No ]
    Parental report and child urine cotinine.

Secondary Outcome Measures:
  • Home Smoking Ban [ Time Frame: Measured from baseline upto 5 months. ] [ Designated as safety issue: No ]
    Parental report of home smoking ban and environmental data collection.

Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real-time Intervention Behavioral: Real-Time Intervention
Lights and Sound Brief Coaching
Other Name: Project Fresh Air
Active Comparator: Usual Education
Participants will receive usual education about secondhand and thirdhand smoke.
Behavioral: Usual Education
Participants will receive usual education about secondhand smoke and thirdhand smoke.
Other Name: Project Fresh Air

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • eligible families will have at least one parent or guardian (18 years of age or older),
  • one household resident (e.g., parent, grandparent, roommate) who smokes tobacco,
  • a child under fourteen years old who is exposed to tobacco smoking in the home, and plans to live in San Diego County for at least three months.

Exclusion Criteria:

  • ineligible Families will have no parents or guardians (18 years of age or older),
  • will not have any household residents (e.g., parent, grandparent, roommate) that smoke tobacco in the home,
  • only have children beyond fourteen years of age, or
  • plans to leave San Diego County in less than three months.
  • families with children who are not exposed to tobacco smoke in the home will not be eligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01634334

United States, California
SDSU - Center for Behavioral Epidemiology and Community Health Recruiting
San Diego, California, United States, 92123
Contact: Melbourne F Hovell, PhD, MPH    858-505-4772   
Contact: Marie C Boman-Davis, MPH    858-505-4770 ext 146   
Principal Investigator: Melbourne F Hovell, PhD, MPH         
Sponsors and Collaborators
San Diego State University
Principal Investigator: Melbourne F Hovell, PhD, MPH SDSU - Center for Behavioral Epidemiology and Community Health
  More Information

No publications provided

Responsible Party: Melbourne Hovell, Principal Investigator, San Diego State University Identifier: NCT01634334     History of Changes
Other Study ID Numbers: R01HL103684
Study First Received: July 2, 2012
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
Secondhand smoke processed this record on March 03, 2015