Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence
Condition: Smoking
Study type: Interventional

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.
    

Intervention name(s): Web+phone
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Smoking; Postpartum; Pregnancy; Quit; Tobacco; Abstinence; Relapse; Relapse prevention