Web and Phone Intervention to Maintain Postpartum Tobacco Abstinence
StayQuit
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 22, 2017
August 1, 2017
1.4 years
May 1, 2013
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Potential predictors of postpartum tobacco relapse
6 months postpartum
Study Arms (2)
Enhanced Web+phone
EXPERIMENTALEngaging and interactive website access plus phone calls from personal coach.
Basic Static Web
ACTIVE COMPARATORStatic website access only, only introductory call.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Research Institutelead
- University of Pittsburghcollaborator
Study Sites (1)
Oregon Research Institute
Eugene, Oregon, 97403, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 30, 2013
Study Start
December 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
August 22, 2017
Record last verified: 2017-08