- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01864954
Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence (StayQuit)
Study Overview
Detailed Description
The primary aims of this project are to:
- Adapt and refine an Enhanced Web+phone intervention for the maintenance of tobacco abstinence postpartum.
Evaluate the feasibility and acceptability of the Enhanced Web+phone tobacco abstinence maintenance program for postpartum women.
Aim 2.1 The investigators hypothesize that the intervention will be feasible as assessed by women's report of helpfulness, relevance and program usability.
Aim 2.2 The investigators hypothesize that the intervention will be acceptable to postpartum women as measured by engagement in and use of the program.
- Estimate the initial efficacy of the Enhanced Web+phone intervention on tobacco abstinence at 3 and 6 months postpartum relative to a Basic Web Information-Only control.
Aim 3.1 The investigators hypothesize that, relative to the Basic Web Information-Only control, the Enhanced Web+phone intervention will be associated with 10-points greater prolonged abstinence rates at 3 and 6 months postpartum.
Aim 3.2 The investigators hypothesize that, relative to Basic Web control, tobacco use outcomes at 3 and 6 months postpartum in the Enhanced Web+phone intervention will be associated with greater improvements (d > .35) in putative mediators of prolonged abstinence (i.e., self-efficacy, intentions to maintain nonsmoking, mood and perceived stress, and weight concerns).
Secondary aim of this proposal is to:
Evaluate potential predictors of postpartum smoking relapse. The investigators will examine pre-pregnancy smoking rate, partner's tobacco use and other demographic factors as predictors of postpartum tobacco relapse. Similarly, the investigators will examine the role of mood, perceived stress and weight concerns as predictors of prolonged abstinence among women in both groups. For example, it may be that women with higher baseline levels of depressive symptoms and perceived stress may be more likely to return to smoking postpartum, regardless of condition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Oregon Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Smoked at least 5 cigarettes/day for at least 1 of the 3 months prior to becoming pregnant
- No smoking during weeks 34 to 38 of pregnancy
- Able to read English
- At least 18 years of age
- Use Web e-mail account at least once per week
- Completed informed assent/consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Enhanced Web+phone
Engaging and interactive website access plus phone calls from personal coach.
|
We propose to evaluate the feasibility, acceptability, and efficacy of a Web+phone treatment program in a small, randomized, controlled pilot study.
Women who have quit smoking during pregnancy will be randomly assigned to either (a) an Enhanced Web+phone intervention or (b) a Basic Web Information-Only control condition.
|
Active Comparator: Basic Static Web
Static website access only, only introductory call.
|
We propose to evaluate the feasibility, acceptability, and efficacy of a Web+phone treatment program in a small, randomized, controlled pilot study.
Women who have quit smoking during pregnancy will be randomly assigned to either (a) an Enhanced Web+phone intervention or (b) a Basic Web Information-Only control condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All tobacco abstinence
Time Frame: 3 and 6 months postpartum
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Measure change in 7-day point all tobacco abstinence and change in prolonged abstinence between 3 and 6 months postpartum.
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3 and 6 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Potential predictors of postpartum tobacco relapse
Time Frame: 6 months postpartum
|
Measure change from baseline in participant-specific variables (e.g.,demographics, smoking history, partner tobacco use, mood, weight concerns) to examine possible predictors of postpartum tobacco relapse.
|
6 months postpartum
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1R01CA140310-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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