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Completed

NCT Number: NCT01864954

Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

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.

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Key information

Conditions

Smoking Behavior Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Research Institute

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Web+phone

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • University of Pittsburgh

Registry information

Acronym: StayQuit

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 30, 2013
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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