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NCT00917943 · ClinicalTrials.gov registry record · NA
Preventing Postpartum Return to Smoking
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 386
- Enrollment target
NCT00917943 is a NA study that has completed, run by Duke University. The registered enrollment target is 386 participants.
The verdict
NCT00917943, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 386 participants
- Enrollment target
Study Summary
STUDY PURPOSE: Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy. Aim 2. To determine the association of baseline risk assessment variables (dependence, motivation, self-efficacy, concerns for the fetus, changes in sensory response to tobacco, depression, weight concerns, and partner/household smoking and support) with time to resumption. A two-arm randomized controlled trial will be conducted. Women's risk for resumption will be assessed at 4 time-points. 1. Between 28 and 34 weeks of pregnancy 2. 6-weeks postpartum 3. 6-months postpartum 4. 12-months postpartum Women who report not smoking at any of the assessment points will be asked to provide a saliva sample for analysis of tobacco constituents and a breath sample to assess carbon monoxide. Bio-behavioral and pregnancy-specific factors will be used to triage women to one of four levels of stepped-care that includes: 1. One in-person counseling session and at least one telephone session during pregnancy and from 6 to 11 telephone sessions over the first 9-months postpartum. 2. Risk profiles will be used to match the intervention to each woman's needs. 3. Women randomized to the control arm will receive the booklet, Forever Free for Baby and Me and usual prenatal and postpartum care. We are recruiting 400 women for this study from 11 sites in the Durham/ Raleigh/ Chapel Hill NC area and Fayetteville NC.
Interventions
- BEHAVIORAL Tailored Counseling Intervention Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 386 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00917943
The ClinicalTrials.gov registry entry for NCT00917943 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 386 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tailored Counseling Intervention Arm is the first listed.
NCT00917943 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00917943 about?
NCT00917943 is a clinical study titled "Preventing Postpartum Return to Smoking". STUDY PURPOSE: Aim 1. To assess the efficacy of an intervention in preventing or delaying postpartum smoking resumption among women who stop smoking during pregnancy. Aim 2. To determine the association of baseline risk assessment variables (dependence, motivation, self-efficacy, concerns for the ...
What is the current status of trial NCT00917943?
This trial is currently completed. It is a NA study. The enrollment target is 386 participants. The study started on 2008-04. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00917943?
The interventions under investigation include: Tailored Counseling Intervention Arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT00917943?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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