Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

Smoking Clinical Trial

— StayQuit  

Official title:

Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01864954
• Other study ID #: 1R01CA140310-01A2
• Status: Completed
• Phase: N/A
• First received: May 1, 2013
• Last updated: August 17, 2017
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: August 2017
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All tobacco abstinence	Measure change in 7-day point all tobacco abstinence and change in prolonged abstinence between 3 and 6 months postpartum.	3 and 6 months postpartum
Secondary	Potential predictors of postpartum tobacco relapse	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.	6 months postpartum

External Links

•   Oregon Research Institute