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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01634334
Other study ID # R01HL103684
Secondary ID
Status Completed
Phase N/A
First received July 2, 2012
Last updated April 13, 2016
Start date May 2012
Est. completion date February 2016

Study information

Verified date April 2016
Source San Diego State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 298
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Real-Time Intervention
Lights and Sound Brief Coaching
Usual Education
Participants will receive usual education about secondhand smoke and thirdhand smoke.

Locations

Country Name City State
United States SDSU - Center for Behavioral Epidemiology and Community Health San Diego California

Sponsors (1)

Lead Sponsor Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Secondhand Smoke Reduction Parental report and child urine cotinine. Measured from baseline upto 5 months No
Secondary Home Smoking Ban Parental report of home smoking ban and environmental data collection. Measured from baseline upto 5 months. No
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