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NCT02117947 · ClinicalTrials.gov registry record · NA
Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers
A NA study, sponsored by Temple University.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT02117947: Completed NA study, sponsored by Temple University.
NCT02117947 is a NA study that has completed, run by Temple University. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117947, a NA study, has completed, sponsored by Temple University.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study Summary
The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in a high risk, medically underserved population of maternal smokers. The program is called "Philadelphia FRESH (Family Rules for Establishing Smokefree Homes)". Participants are recruited from low-income urban neighborhoods in Philadelphia, Pennsylvania. After determining study eligibility via telephone screen, all participants complete an in-home pre-intervention interview that includes self-reported smoking history, current smoking and exposure patterns, and factors that relate to maternal smoking (such as depressive symptoms, weight concerns, nicotine dependence,) as well as collection of child urine cotinine (a biomarker used to detect SHSe). Participants are randomized after baseline to receive either (a) a moderately intensive (up to 2 in-home sessions, 8 phone sessions) Behavioral Counseling intervention (BC) delivered over a 16-week period by counselors trained and supervised by investigators, or (b) an enhanced Self-Help Control (SHC) that uses brief advice and a detailed self-help manual for SHSe-reduction and smokingcessation. Post intervention assessments include self-reports of intervention process, factors associated with intervention effects, and intervention outcomes that include child urine cotinine (to measure level of SHSe) and participant saliva cotinine (to verify self-reported smoking quit status). Interviewers and data management staff remain blind to the treatment assignment. All procedures are implemented after signed informed consent and were approved by Temple University's Institutional Review Board.
Primary Outcome
tobacco exposure biomarker measured in n/mL
Interventions
- BEHAVIORAL Behavioral Counseling
- BEHAVIORAL Self-help control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2004-07 |
| Est. Completion | 2011-06 |
| Phase | NA |
What the finished NCT02117947 record still lists
NCT02117947 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Behavioral Counseling is the first listed.
NCT02117947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02117947 about?
NCT02117947 is a clinical study titled "Counseling to Reduce Children's SHS Exposure: A Trial With Maternal Smokers". The goal of this study is to reduce infant and toddlers' secondhand smoke exposure (SHSe) in a high risk, medically underserved population of maternal smokers. The program is called "Philadelphia FRESH (Family Rules for Establishing Smokefree Homes)". Participants are recruited from low-income urban...
What is the current status of trial NCT02117947?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2004-07. Estimated completion is 2011-06.
What interventions are being tested in trial NCT02117947?
The interventions under investigation include: Behavioral Counseling (BEHAVIORAL), Self-help control (BEHAVIORAL).
Who is sponsoring clinical trial NCT02117947?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02117947's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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