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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00927264 |
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Date of registration:
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23/06/2009 |
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Primary sponsor: |
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Public title:
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PRIDE: Preventing Respiratory Illnesses During Childhood Study
PRIDE |
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Scientific title:
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A+ Head Start Intervention for Smoke Free Homes |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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350 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00927264 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Cynthia S Rand, PhD |
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Address:
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Telephone:
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410-550-1505 |
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Email:
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crand@jhmi.edu |
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Affiliation:
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Name:
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Cynthia S Rand, PhD |
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Address:
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Telephone:
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410-550-1505 |
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Email:
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crand@jhmi.edu |
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Affiliation:
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Name:
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Cynthia S Rand, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- child enrolled in Baltimore city Head Start/ smoker in home
Exclusion Criteria:
- no smoker in home/ does not speak English/is enrolled in other respiratory research
study
Age minimum:
6 Months
Age maximum:
6 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tobacco Smoke Pollution
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Intervention(s)
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Behavioral: Behavioral; Motivational Interviewing Intervention for ETS Reductaion
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Primary Outcome(s)
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Air nicotine levels, as an indicator of child's exposure to environmental tobacco smoke (ETS)
[Time Frame: Measured at baseline, 3, 6 and 12 months.]
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Secondary Outcome(s)
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Changes in smoking in home by household members
[Time Frame: Measured at baseline, 3, 6 and 12 months]
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ETS reduction, as measured by child's cotinine levels
[Time Frame: Measured at baseline, 3, 6 and 12 months.]
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Head Start staff knowledge, attitudes and practices regarding ETS exposure and reduction
[Time Frame: Measured at baseline and 3, 6 and 12 months]
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Health care utilizations by self report of parent
[Time Frame: Measured at baseline and 3, 6 and 12 months]
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Respiratory function of child by self report of parent
[Time Frame: Measured at baseline, 3, 6 & 12 months]
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Secondary ID(s)
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664
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R18HL092901-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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