Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence
NCT ID: NCT01864954
Last Updated: 2017-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2013-12-31
2015-05-31
Brief Summary
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Detailed Description
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1. Adapt and refine an Enhanced Web+phone intervention for the maintenance of tobacco abstinence postpartum.
2. 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.
3. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Enhanced Web+phone
Engaging and interactive website access plus phone calls from personal coach.
Web+phone
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.
Basic Static Web
Static website access only, only introductory call.
Web+phone
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.
Interventions
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Web+phone
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
60 Years
FEMALE
No
Sponsors
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University of Pittsburgh
OTHER
Oregon Research Institute
OTHER
Responsible Party
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Locations
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Oregon Research Institute
Eugene, Oregon, United States
Countries
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Related Links
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Oregon Research Institute
Other Identifiers
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