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Completed

NCT Number: NCT00360581

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

The purpose of this study is to develop strategies to maintain smoking abstinence initiated in pregnancy and prevent relapse in the postpartum period.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Pittsburgh School of Nursing

Pittsburgh, Pennsylvania, 15261, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Yoga

Behavioral

Yoga and Cognitive Behavioral Therapy

Behavioral

Primary outcomes

  1. smoking abstinence by CO testing

Secondary outcomes

  1. smoking abstinence by self-report

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2006
Study completion
2008
First posted
Aug 4, 2006
Registry last updated
Feb 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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