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Improving Household Air Quality in Homes With Children (ProjFreshAir)

This study is currently recruiting participants.
Verified July 2012 by San Diego State University
Sponsor:
Information provided by (Responsible Party):
Melbourne Hovell, San Diego State University
ClinicalTrials.gov Identifier:
NCT01634334
First received: July 2, 2012
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Asthma
 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:

MedlinePlus related topics: Asthma Smoking
U.S. FDA Resources

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • ineligible Families will have no parents (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 five years of age, or
  • plans to leave San Diego County in less than six months.
  • families with children who are not exposed to tobacco smoke in the home will not be eligible. Children receiving breast milk will also not be included to avoid confounding of cotinine assays.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634334

Locations
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     mhovell@projects.sdsu.edu    
Contact: Marie C Boman-Davis, MPH     858-505-4770 ext 146     mboman@projects.sdsu.edu    
Principal Investigator: Melbourne F Hovell, PhD, MPH            
Sponsors and Collaborators
San Diego State University
Investigators
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
ClinicalTrials.gov Identifier: NCT01634334     History of Changes
Other Study ID Numbers: R01HL103684
Study First Received: July 2, 2012
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
Secondhand smoke

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013