Phase 2
N=110
Computer-Assisted Intervention for Smoking During Pregnancy
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT01028131 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Smoking Behavior (Self-report Confirmed by Expired Breath CO) — 2; 7; 2; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Computer-delivered brief intervention (5As) (Behavioral); Contingency Management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wayne State University
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Behavior (Self-report Confirmed by Expired Breath CO) |
2; 7; 2; 5 | — |
| PRIMARY Urinary Cotinine |
4; 10; 3; 4 | — |
Summary
This study will develop:
1. Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.
Eligibility Criteria
Inclusion Criteria
- at least 18 years
- pregnant, gestation <= 27 weeks
- cigarette smoking in the past week (even if only one puff)
Exclusion Criteria
- inability to speak or understand spoken English
- do not intend to carry pregnancy to full term
- frank psychosis
Data sourced from ClinicalTrials.gov (NCT01028131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.