Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: Web+phone

• Registration Number: NCT01864954
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-30
• Study Start: 2013-12
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Web+phone	Web+phone	Engaging and interactive website access plus phone calls from personal coach.
Basic Static Web	Web+phone	Static website access only, only introductory call.

Primary Outcome Measures

Name	Time	Method
All tobacco abstinence	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

Name	Time	Method
Potential predictors of postpartum tobacco relapse	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.

Trial Locations

Locations (1)

Oregon Research Institute; 🇺🇸 Eugene, Oregon, United States