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Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence (StayQuit)

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ClinicalTrials.gov Identifier: NCT01864954
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
This study seeks to develop and test a Web-based tobacco relapse prevention program targeting postpartum women who quit smoking for pregnancy. Participants are randomly assigned to one of two conditions: (1) an Enhanced Web+phone Condition that receives access to an interactive Web-based intervention plus up to 3 brief supportive phone calls from a personal coach; (2) A Basic Web Information-Only Control Condition that receives access to an informational website plus an introductory phone call. The hypothesis is that Women in the Enhanced Condition will be more successful in avoiding tobacco relapse than women assigned to the Basic Control Condition.

Condition or disease Intervention/treatment Phase
Smoking Behavioral: Web+phone Not Applicable

Detailed Description:

The primary aims of this project are to:

  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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence
Study Start Date : December 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enhanced Web+phone
Engaging and interactive website access plus phone calls from personal coach.
Behavioral: 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.

Active Comparator: Basic Static Web
Static website access only, only introductory call.
Behavioral: 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.




Primary Outcome Measures :
  1. All tobacco abstinence [ Time Frame: 3 and 6 months postpartum ]
    Measure change in 7-day point all tobacco abstinence and change in prolonged abstinence between 3 and 6 months postpartum.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864954


Locations
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United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
University of Pittsburgh

Additional Information:
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Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01864954     History of Changes
Other Study ID Numbers: 1R01CA140310-01A2 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by Oregon Research Institute:
Smoking
Postpartum
Pregnancy
Quit
Tobacco
Abstinence
Relapse
Relapse prevention
Additional relevant MeSH terms:
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Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents