Clinical trial NCT01864954: Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence
Official title: Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Postpartum
Pregnancy
Quit
Tobacco
Abstinence
Relapse
Relapse prevention
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2013-05-30
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: All tobacco abstinence
timeFrame: 3 and 6 months postpartum
Secondary outcomes:
measure: Potential predictors of postpartum tobacco relapse
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
References: