Vigorous Exercise for Depressed Smokers
Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers
1 other identifier
interventional
30
1 country
1
Brief Summary
In this project the investigators will develop and pilot test a supervised, vigorous intensity exercise intervention for depressed female smokers. If the pilot intervention is successful the investigators will have a blueprint for a large randomized controlled trial. The long term objective is to develop interventions for depressed women that will ultimately reduce their risk of tobacco-caused disease and mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2013
Typical duration for not_applicable
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
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 14, 2016
January 1, 2016
2.6 years
May 21, 2013
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
smoking abstinence
Smoking cessation biochemically confirmed
6 months
Secondary Outcomes (1)
depressive symptoms
6 months
Study Arms (2)
health education
ACTIVE COMPARATORhealth education control
exercise
EXPERIMENTALvigorous supervised exercise
Interventions
Eligibility Criteria
You may qualify if:
- depressed (CES-D) score 16 or above
- years of age
- female gender
- sedentary
- current cigarette smoker
You may not qualify if:
- smoking cessation medication
- Not able to exercise medically
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PMID: 34611902DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christi Patten, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychology
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 23, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 14, 2016
Record last verified: 2016-01