Ignite Creation Date:
2024-05-06 @ 9:50 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03080090
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2017-02-24
Brief Title:
YMCA Exercise Intervention for Smoking Cessation Study
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
YMCA Exercise Intervention for Smoking Cessation Study
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cigarette smoking is the leading cause of death and disability in the United States Although smoking has declined since 1964 it is still very common among some groups of people One such group is persons with emotional symptoms and disorders There has been little success in developing treatments for smoking cessation for smokers with affective disturbances
Recent work suggests that being sensitive to and less tolerant of stress is associated with many problems in daily life People with high stress sensitivity tend to use avoidant strategies to cope with their stress like smoking Also people with high levels of stress sensitivity report stronger beliefs that smoking will reduce negative feelings They also report having a harder time quitting and in fact are less successful at doing so This information suggests that stress sensitivity is important to target during smoking cessation treatment for smokers with affective vulnerabilities
This clinical trial will evaluate a treatment that integrates exercise to reduce stress sensitivity among high stress sensitive smokers It builds directly from our recent work and we now seek to adapt it to a more a more accessible and sustainable application Results will provide important information on the benefit of an integrated intervention that could be used in the community for smokers at great risk for relapse and who do not benefit from existing alternative treatments This study is the first to test an intervention for stress sensitive smokers and has the potential to help at-risk individuals experience quitting success and ultimately reduce the burden of tobacco-related cancers in Texas
Recent work suggests that being sensitive to and less tolerant of stress is associated with many problems in daily life People with high stress sensitivity tend to use avoidant strategies to cope with their stress like smoking Also people with high levels of stress sensitivity report stronger beliefs that smoking will reduce negative feelings They also report having a harder time quitting and in fact are less successful at doing so This information suggests that stress sensitivity is important to target during smoking cessation treatment for smokers with affective vulnerabilities
This clinical trial will evaluate a treatment that integrates exercise to reduce stress sensitivity among high stress sensitive smokers It builds directly from our recent work and we now seek to adapt it to a more a more accessible and sustainable application Results will provide important information on the benefit of an integrated intervention that could be used in the community for smokers at great risk for relapse and who do not benefit from existing alternative treatments This study is the first to test an intervention for stress sensitive smokers and has the potential to help at-risk individuals experience quitting success and ultimately reduce the burden of tobacco-related cancers in Texas
Detailed Description:
Experimental Group Participants will select a YMCA branch and be assigned a personal fitness instructor who will act as their case manager overseeing the integrated exercise-based intervention for smoking cessation Guided by our pilot data showing efficacy and tolerability of the exercise dose the exercise intervention consists of 75 minutesweek of aerobic training at vigorous-intensity for 15 weeks2 As in the previous study the aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 60 to 85 of age-predicted heart rate reserve ie vigorous intensity 2 In order to maximize adherence the days of the week and training progression schedule will be individualized for each participant based on initial fitness level travel and any other issues
The participant and fitness instructor will meet for three sessions during the first week of exercise training During the first session the fitness instructor will describe the program ie treatment model and aims set a target quit attempt for week 6 develop an exercise training schedule and supervise the first exercise session to ensure the participant is exercising properly After two more supervised exercise sessions during the first week the pair will meet one day per week during the following 14 weeks of the study The fitness instructors will be responsible for monitoring sessions weekly problem-solving any difficulties adjusting the aerobic andor resistance training regimen as appropriate and entering the participants exercise data into the REDCap database specifically designed for the study
At the beginning of week 3 the fitness instructor will connect the participant with the quitline ie warm transfer The Tobacco quitlines are now available in every US state via a national quitline portal 1-800-QUIT-NOW and have become the major vehicle through which smoking cessation services are delivered in the US73 All participants will receive the standard telephone counseling package of up to 5 proactive calls from the Texas Tobacco Quitline httpswwwquitnownettexas we will use a warm transfer ie call the quitline in the presence of the smoker and put them on the phone for the intake interview Call 1 is an assessment and planning call Call 2 is a pre-quit date call Call 3 is a quit date call and Calls 4 and 5 are maintenance calls if the smoker has quit or problem solving calls if they have not quit Overall the counseling protocol aims to 1 provide cognitive-behavioral smoking cessation and relapse prevention tools tailored to the individual smokers characteristics and 2 provide medication management and advice regarding nicotine patch use and adherence support with the goal of completing a full course of medication - in this case 8 weeks of transdermal nicotine patch use
On the target quit day the fitness instructor will provide the participants with Nicoderm CQ 24-hour transdermal nicotine patches TNP as part of the study We chose to provide the patch for 8 weeks because longer than 8 weeks does not appear to improve treatment efficacy10 We chose the TNP because of the extensive empirical literature supporting its effectiveness and safety its ease of use and its relatively benign side effect profile that have led to its approval as an over-the-counter medication74 Quitline staff provide instructions on dose and tapering schedule in a fashion consistent with that used in previous trials with a similar formulation of the patch10
Control Group The intervention procedures for this group are identical to the Experimental Group group except that the target training intensity will be self-selected at 20 to 40 of age-predicted heart rate reserve ie light intensity
The participant and fitness instructor will meet for three sessions during the first week of exercise training During the first session the fitness instructor will describe the program ie treatment model and aims set a target quit attempt for week 6 develop an exercise training schedule and supervise the first exercise session to ensure the participant is exercising properly After two more supervised exercise sessions during the first week the pair will meet one day per week during the following 14 weeks of the study The fitness instructors will be responsible for monitoring sessions weekly problem-solving any difficulties adjusting the aerobic andor resistance training regimen as appropriate and entering the participants exercise data into the REDCap database specifically designed for the study
At the beginning of week 3 the fitness instructor will connect the participant with the quitline ie warm transfer The Tobacco quitlines are now available in every US state via a national quitline portal 1-800-QUIT-NOW and have become the major vehicle through which smoking cessation services are delivered in the US73 All participants will receive the standard telephone counseling package of up to 5 proactive calls from the Texas Tobacco Quitline httpswwwquitnownettexas we will use a warm transfer ie call the quitline in the presence of the smoker and put them on the phone for the intake interview Call 1 is an assessment and planning call Call 2 is a pre-quit date call Call 3 is a quit date call and Calls 4 and 5 are maintenance calls if the smoker has quit or problem solving calls if they have not quit Overall the counseling protocol aims to 1 provide cognitive-behavioral smoking cessation and relapse prevention tools tailored to the individual smokers characteristics and 2 provide medication management and advice regarding nicotine patch use and adherence support with the goal of completing a full course of medication - in this case 8 weeks of transdermal nicotine patch use
On the target quit day the fitness instructor will provide the participants with Nicoderm CQ 24-hour transdermal nicotine patches TNP as part of the study We chose to provide the patch for 8 weeks because longer than 8 weeks does not appear to improve treatment efficacy10 We chose the TNP because of the extensive empirical literature supporting its effectiveness and safety its ease of use and its relatively benign side effect profile that have led to its approval as an over-the-counter medication74 Quitline staff provide instructions on dose and tapering schedule in a fashion consistent with that used in previous trials with a similar formulation of the patch10
Control Group The intervention procedures for this group are identical to the Experimental Group group except that the target training intensity will be self-selected at 20 to 40 of age-predicted heart rate reserve ie light intensity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None