Lung DiseasesProjFreshAirNCT01634334
Improving Household Air Quality in Homes With Children
A study testing Real-Time Intervention and Usual Education in people with Lung Diseases and Asthma, run by San Diego State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Asthma
- What is being tested?
- Real-Time Intervention and Usual Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
SDSU - Center for Behavioral Epidemiology and Community Health
San Diego, California, 92123
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Diseases, Asthma
- Being tested
- Real-Time Intervention, Usual Education
- Keywords
- Secondhand smoke
- Medical subject headings
- Lung Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time InterventionBehavioural
Lights and Sound Brief Coaching
Usual EducationBehavioural
Participants will receive usual education about secondhand smoke and thirdhand smoke.
| Study group | Role | What they receive |
|---|---|---|
| Real-time Intervention | Experimental | Not described Receives: Behavioral: Real-Time Intervention |
| Usual Education | Active comparator | Participants will receive usual education about secondhand and thirdhand smoke. Receives: Behavioral: Usual Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondhand Smoke Reduction
Parental report and child urine cotinine.
Measured: Measured from baseline upto 5 months
Secondary outcomes (1)
Home Smoking Ban
Parental report of home smoking ban and environmental data collection.
Measured: Measured from baseline upto 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melbourne Hovell, San Diego State University
- Investigators
- Melbourne F Hovell, PhD, MPH, Principal investigator, SDSU - Center for Behavioral Epidemiology and Community Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634334
- Sponsor's protocol ID
- R01HL103684
- Acronym
- ProjFreshAir
- Status last verified
- Apr 2016
- First submitted
- 2 Jul 2012
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 30770436Hughes 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.
PubMed 29305069
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation for Smoke-Free Homes: Real-Time Feedback
- ClinicalTrials.gov ID
- NCT01634334
- Acronym / sponsor ID
- ProjFreshAir / R01HL103684
- Conditions
- Lung Diseases, Asthma
- Keywords
- Secondhand smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-time Intervention | Experimental | Behavioral: Real-Time Intervention |
| Usual Education | Active comparator | Behavioral: Usual EducationParticipants will receive usual education about secondhand and thirdhand smoke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time InterventionLights and Sound Brief Coaching | Behavioural | Real-time Intervention |
| Usual EducationParticipants will receive usual education about secondhand smoke and thirdhand smoke. | Behavioural | Usual Education |
Primary outcome
Secondhand Smoke Reduction
Time frame: Measured from baseline upto 5 months
Parental report and child urine cotinine.
1 secondary outcome
Home Smoking Ban
Time frame: Measured from baseline upto 5 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 30770436Hovell 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.
- Derived from this study: PubMed 29305069Hughes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melbourne F Hovell, PhD, MPH principal investigator
SDSU - Center for Behavioral Epidemiology and Community Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Intervention and Usual Education in people with Lung Diseases and Asthma, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondhand Smoke Reduction (time frame: Measured from baseline upto 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01634334, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.