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Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study

Primary Purpose

Smoking Cessation

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yoga
Yoga and Cognitive Behavioral Therapy
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation focused on measuring Smoking abstinence

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Must have the ability to read, write, and understand English. Must have quit smoking during their current pregnancy. Must possess the desire to remain smoke-free after delivery. Obtain permission from obstetrician to participate in yoga. Must be reachable by telephone. If subject becomes pregnant again while in the study, she can still participate with written permission from her primary care physician. Exclusion Criteria: Untreated hypertension. A history of: glaucoma, major depression, alcohol abuse or substance disorder, anorexia nervosa, or head trauma. Recent abdominal surgery (such as caesarean section).

Sites / Locations

  • University of Pittsburgh School of Nursing

Outcomes

Primary Outcome Measures

smoking abstinence by CO testing

Secondary Outcome Measures

smoking abstinence by self-report

Full Information

First Posted
August 2, 2006
Last Updated
February 7, 2008
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT00360581
Brief Title
Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study
Official Title
Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to develop strategies to maintain smoking abstinence initiated in pregnancy and prevent relapse in the postpartum period.
Detailed Description
Many women quit smoking during pregnancy, but postpartum relapse rates are high, approximately, 50-80% (Van't Hof, et al). The majority of women who quit smoking during pregnancy resume smoking within the first 3 months postpartum (McBride, et al). The environmental risks of tobacco smoke on the newborn child can lead to acute respiratory infections, bronchitis, pneumonia, and SIDS. Several studies have tried to identify reasons for the high rates of relapse. Postpartum relapse has been attributed to decreased self-efficacy, the lack of effective coping strategies to resist temptation to smoke, and weight concerns (McBride, et al). Addictive behaviors such as smoking are learned behavioral means of coping. By learning new rules for dealing with problems, a behavior can be modified or unlearned. Physical exercise, when combined with cognitive behavioral therapy (CBT) as a smoking cessation treatment, is useful in the maintenance of smoking cessation in women. Yoga, as a form of exercise, has been shown to promote the desire to stop smoking and enhance subjective well-being and mood. Though untested in postpartum relapse prevention, yoga practice, when coupled with CBT, may address both mood and physiologic postpartum sensations that may be associated with the prevention of smoking relapse. Women are more apt to decrease or even stop smoking during pregnancy, and if successful in sustaining cessation, are likely to live longer. This randomized exploratory pilot study will use a controlled parallel group design using smoking cessation yoga intervention and cognitive behavioral therapy. The study will include a total of 30 participants aged 18-45 years. Smoking status will be identified by self-report and carbon monoxide testing at enrollment. At randomization and following time points, smoking status will be identified by self-report and confirmed by carbon monoxide testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
Smoking abstinence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Type
Behavioral
Intervention Name(s)
Yoga and Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
smoking abstinence by CO testing
Secondary Outcome Measure Information:
Title
smoking abstinence by self-report

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must have the ability to read, write, and understand English. Must have quit smoking during their current pregnancy. Must possess the desire to remain smoke-free after delivery. Obtain permission from obstetrician to participate in yoga. Must be reachable by telephone. If subject becomes pregnant again while in the study, she can still participate with written permission from her primary care physician. Exclusion Criteria: Untreated hypertension. A history of: glaucoma, major depression, alcohol abuse or substance disorder, anorexia nervosa, or head trauma. Recent abdominal surgery (such as caesarean section).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan A. Albrecht PhD, RN, FAAN
Organizational Affiliation
University of Pittsburgh School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh School of Nursing
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

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Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study

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