NCT01030068

Brief Summary

The purpose of this study is to test whether it is feasible to provide a smoking cessation program together with a yoga program to help women quit smoking. We anticipate that women will be enthusiastic about the program and that we will be able to recruit and treat women for smoking cessation within the designated time frame.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

4 years

First QC Date

December 9, 2009

Last Update Submit

October 6, 2011

Conditions

Smoking Cessation

Keywords

Smoking CessationYogaWellnessFeasibilitySmoking Cessation Therapy

Outcome Measures

Primary Outcomes (1)

  • Recruitment and qualitative feasibility

    10 week

Secondary Outcomes (1)

  • Smoking cessation

    6 month

Study Arms (2)

Yoga

EXPERIMENTAL

Yoga plus smoking cessation

Behavioral: YogaOther: Smoking cessation therapy

Wellness

ACTIVE COMPARATOR

Health \& Wellness classes plus smoking cessation therapy

Behavioral: WellnessOther: Smoking cessation therapy

Interventions

YogaBEHAVIORAL

Yoga twice weekly

Yoga
WellnessBEHAVIORAL

Health and wellness classes twice weekly

Wellness
Smoking cessation therapyOTHER

Smoking cessation therapy

WellnessYoga

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy female smokers
  • ages 18-65
  • smoke 10+ cigarettes a day
  • sedentary (not exercising more than 2 times per week)

You may not qualify if:

  • major depression
  • hypertension
  • more than 1 year previous yoga experience
  • current experience with yoga or smoking cessation treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

YogaHealth

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesPopulation Characteristics

Study Officials

  • Beth C Bock, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry & Human Behavior

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 11, 2009

Study Start

July 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

US(1)