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NCT02211430 · ClinicalTrials.gov registry record · NA
Smoking Cessation for Low-Income Pregnant Women
A NA study, sponsored by Fox Chase Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 277
- Enrollment target
NCT02211430: Completed NA study, sponsored by Fox Chase Cancer Center.
NCT02211430 is a NA study that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 277 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02211430, a NA study, has completed, sponsored by Fox Chase Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 277 participants
- Enrollment target
Study Summary
To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation intervention for low-income, minority women conducted in the prenatal and postpartum phases. Considering the strong link between tobacco use and cancer risk, the development of effective smoking cessation treatments has important health implications for cancer prevention and control initiatives. The aims to be addressed are: Aim 1: To compare an enhanced Cognitive-Behavioral Counseling (CBC) smoking cessation intervention with a Best Practice control condition (BP) for reducing smoking rates (i.e., continued abstinence, 7-day point prevalence, and number of cigarettes smoked) in the short- and long-term among pregnant women. It is hypothesized that smokers receiving CBC will show reduced rates of tobacco use, versus those in the BP, over time. Aim 2: To evaluate the impact of the CBC intervention on the hypothesized mediators of behavior change (i.e., heightened risk perceptions; enhanced self-efficacy and reduced fatalistic beliefs; high pros and low cons of quitting; reduced emotional distress). It is hypothesized that the psychosocial factors will mediate the effect of the CBC intervention on change of smoking behaviors.
Primary Outcome
Self-reported quit status will be assessed using continuous abstinence and 7-day point prevalence. Assessment of continuous abstinence consists of interviewing the participant to record their smoking practices on each day from the preceding data point to the current interview date (e.g., duration between the quit date and the end of treatment). In addition, saliva cotinine level will be examined to validate self-report smoking status. Participants with a cotinine level of 10mg or above will be c
Interventions
- BEHAVIORAL Cognitive-Behavioral Counseling (CBC)
- BEHAVIORAL Best Practice (BC) Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2002-10 |
| Est. Completion | 2007-03 |
| Phase | NA |
What the finished NCT02211430 record still lists
NCT02211430 is an interventional study that assigns participants to a tested intervention. The registered 277 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Cognitive-Behavioral Counseling (CBC) is the first listed.
NCT02211430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02211430 about?
NCT02211430 is a clinical study titled "Smoking Cessation for Low-Income Pregnant Women". To meet the Healthy People 2010 objective of increasing tobacco abstinence among pregnant women to 90%, new methods for treating nicotine addiction among pregnant women are needed. To this end, we propose to evaluate an innovative cognitive-behavioral smoking cessation intervention for low-income, m...
What is the current status of trial NCT02211430?
This trial is currently completed. It is a NA study. The enrollment target is 277 participants. The study started on 2002-10. Estimated completion is 2007-03.
What interventions are being tested in trial NCT02211430?
The interventions under investigation include: Cognitive-Behavioral Counseling (CBC) (BEHAVIORAL), Best Practice (BC) Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT02211430?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02211430's enrollment target sits among peer trials
277 383rd of 2000 higher than 1,618 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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