Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.
STEP3
Efficacy and Implementation of Exercise-based Smoking Cessation Treatment for Adults With High Anxiety Sensitivity.
2 other identifiers
interventional
360
1 country
1
Brief Summary
Anxiety sensitivity, reflecting the fear of bodily sensations, is a risk factor for the maintenance and relapse of smoking. This study is designed to address the question - is a smoking cessation intervention personalized to high anxiety sensitive smokers and adapted for implementation by the YMCA effective among racially/ethnically diverse samples?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2023
Longer than P75 for phase_3
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
September 7, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 27, 2025
April 1, 2025
3.5 years
September 7, 2023
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
7-day point prevalence abstinence (PPA) at 6-month follow-up
Self-report of no smoking (not even a puff) during the previous 7 days, verified by expired carbon monoxide (CO; ≤5ppm), saliva cotinine (\<30 ng/mL), or significant other, and not invalidated by any of these verification measures. Failure to provide any of these 3 verification measures will result in PPA being considered missing.
Protocol week 30, which is 24 weeks (6 months) after the quit attempt (set at week 6)
Secondary Outcomes (2)
7-day point prevalence abstinence (PPA) at 12-month follow-up
Protocol week 54, which is 48 weeks (12 months) after the quit attempt (set at week 6)
7-day point prevalence abstinence (PPA) at 9-month follow-up
Protocol week 42, which is 36 weeks (9 months) after the quit attempt (set at week 6)
Study Arms (2)
High-Intensity Aerobic Exercise
EXPERIMENTALParticipants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 60-85% of the their heart rate reserve.
Low-Intensity Aerobic Exercise
ACTIVE COMPARATORParticipants assigned to this arm will be instructed to complete 75 minutes per week of aerobic training at 20-40% of the their heart rate reserve.
Interventions
Participants will select a YMCA branch and will be assigned a personal fitness instructor who will oversee a 15-week exercise intervention. The weekly exercise prescription is 75 minutes of aerobic training.
Participants will receive the standard tobacco cessation package of up to 5 proactive interactions from the Texas Tobacco Quitline (TTQ). Interactions are typically phone calls, but can be chat or live text if the participant prefers. Interaction 1 is for assessment and quit date planning, Interaction 2 occurs prior to the quit date and can be a group session, Interaction 3 occurs shortly following the quit date, and Interactions 4 and 5 are for relapse prevention if the smoker has quit or problem solving if they have not quit. TTQ also offers a tobacco cessation text messaging program and access to a web portal with a variety of cessation resources.
On the target quit day (week 6), participants will be provided 8 weeks of nicotine replacement therapy (24-hour transdermal nicotine patches \[TNP\]).
Eligibility Criteria
You may qualify if:
- Adult (age ≥ 18);
- High Anxiety Sensitivity (≥5 on the Short Scale Anxiety Sensitivity Index \[SSASI\]);
- Daily smoker, ≥5 cigarettes (including e-cigarettes, little cigars/cigarillos) for ≥1 year;
- Motivated to quit smoking as evidenced by a score of ≥5 on a 0-10 Likert scale;
- Body mass index \<40;
- Medical clearance to participate.
- Located near a participating YMCA site (within 50 miles)
You may not qualify if:
- Regular exercise defined as engaging in vigorous-intensity exercise for at least 75 minutes per week for the last 3 months
- Receiving current intervention for smoking cessation.
- Outstanding debt to the YMCA
- Listed as a sex offender on the National Sex Offender Registry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jasper A. Smitslead
- University of Houstoncollaborator
- University of Oklahomacollaborator
- National Cancer Institute (NCI)collaborator
- YMCAcollaborator
Study Sites (1)
University of Texas at Austin
Austin, Texas, 78712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jasper Smits, PhD
University of Texas at Austin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 7, 2023
First Posted
September 25, 2023
Study Start
December 27, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
April 27, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Within one year of completion (publication) of the primary aims. No end date.
- Access Criteria
- Data will be released directly by Dr. Smits's team at UT to investigators providing evidence of their institution's IRB approval for planned analyses of the data.
Within one year of completion (publication) of the primary aims for this project, we will provide de-identified data from this project to interested researchers. The data are to be provided in a SPSS file or Excel, with separate documentation of labels/characteristics for each column of data. Data will be released directly by Dr. Smits's team at UT to investigators providing evidence of their institution's IRB approval for planned analyses of the data.