Sedentary LifestylePhase 1NCT02220465
Step-up to Quit: Using Low-to-moderate Intensity Exercise for Reducing Smoking Cue Reactivity Among Low-income Smokers
A Phase 1 study testing PA+ Smoking Cessation (LMPA) in people with Sedentary Lifestyle and Cigarette Smoking, run by Temple University at 1 site in United States.
Trial summary
The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle, Cigarette Smoking
- What is being tested?
- PA+ Smoking Cessation (LMPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- intent-to-treat sedentary male and female smokers (intention to quit within the next 6 months) - - - smoke 6 or more cigarettes per day.
- Sedentary critieria: not purposeful physical activity for less than 20 minutes of vigorous intensity, or less than 60 minutes of moderate intensity physical activity per week, or less than 100 minutes of time spent walking per week.
Who cannot join
- pregnancy
- current substance abuse (e.g., alcohol, cocaine, or stimulants);
- current diagnosis or treatment of bipolar and psychotic disorder (e.g., use of Haldol, Thorazine).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Temple university
Philadelphia, Pennsylvania, 19122
Uma Nair, PhD, 215-204-6251, uma.nair@temple.edu
Bradley N Collins, phD, collinsb@temple.edu
About this study
Official title: Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking
The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to standard care smoking cessation counseling (control group) in a sample of low-income sedentary male and female smokers. The study will also test the hypothesis that the participants randomized to the LMPA intervention will have greater quit rates at one-week and one-month post quit day follow ups.
Read the detailed description
Tobacco use and lack of physical activity (PA) are preventable health behaviors contributing to disproportionate rates of morbidity/mortality (MM) among low income underserved adults. Comprehensive interventions incorporating treatment of multiple risk behaviors can have immense public health impact. The goal of this study is to improve uptake of PA during the pre-quit period by promoting low to moderate intensity PA (LMPA/walking) during the pre-quit preparatory period to promote smoking cessation among low-income sedentary smokers. Eligible participants (sedentary, >5 cigs/day) will be randomized to 8-week LMPA vs. standard of care (SCC) intervention. LMPA group intervention focuses on (a) increasing daily steps using a tailored algorithm with a goal of reaching 10,000 steps/day by Week 4 (quit day) and (b) integrates PA with evidence-based smoking cessation programming by explicitly linking short bouts of PA with urge management training during the pre-quit period. The SCC group receives standard care smoking cessation counseling. Group differences in quit day reduction (extinction) of smoking urge reactivity using an analog cue-exposure paradigm, and smoking quit rates at 1-week and 1-month follow-up will be examined.
- Conditions
- Sedentary Lifestyle, Cigarette Smoking
- Being tested
- PA+ Smoking Cessation (LMPA), Standard Care Smoking Counseling (SCC)
- Keywords
- sedentary, smoking, cue reactivity, physical activity
- Medical subject headings
- Sedentary Behavior, Cigarette Smoking, Smoking, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA+ Smoking Cessation (LMPA)Behavioural
Standard Care Smoking Counseling (SCC)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| PA+ Smoking Cessation (LMPA) | Experimental | This intervention integrates low-to-moderate physical activity (PA) with evidence based smoking cessation programming. Over the 4-week treatment period, the intervention (1 in-person and 3 phone counseling sessions) focuses on (a) gradually increasing routine PA during the pre-quit period and maintaining PA post quit day (b) increasing daily PA (steps/day) using a weekly tailored algorithm with the goal of achieving 10,000 steps by Week 4 (quit day) and (c) training participants to use PA as a primary urge management strategy, thereby embedding PA within evidence-based smoking cessation counseling. Other components include additional smoking urge management skills, increasing motivation to quit, overcoming barriers and maintaining PA for quitting and staying smoke-free . Receives: Behavioral: PA+ Smoking Cessation (LMPA) |
| Standard Care Smoking Counseling (SCC) | Active comparator | The control intervention parallels the format of the LMPA intervention with focus only on behavioral and cognitive urge management strategies (avoiding/escaping high-risk situations, stimulus control) and minimizing the probability that participants in the control group would increase increase/use PA during the intervention period. Participants are provided a pedometer without any instructions or encouragement around increasing walking/steps during the 8-week intervention period. Receives: Behavioral: Standard Care Smoking Counseling (SCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cue Reactivity on Quit Day
smoking cue reactivity is a behavioral predictor of smoking outcomes. We anticipate that the LMPA intervention will experience greater reductions (extinction) during a controlled, massed cue exposure procedure on their quit day than the Standard care control (SCC) group.
Measured: 4-weeks
Secondary outcomes (1)
Quit rates at follow ups
7-day point prevalence abstinence will be assessed using the 7-day timeline follow back administered at 1-week and 1-month follow up.
Measured: 7 days prior to 1week and 1 month follow up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uma S Nair, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220465
- Sponsor's protocol ID
- 13CRP14560028
- Status last verified
- Jan 2014
- First submitted
- 15 Aug 2014
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nair US, Haynes P, Collins BN. Baseline sleep quality is a significant predictor of quit-day smoking self-efficacy among low-income treatment-seeking smokers. J Health Psychol. 2019 Sep;24(11):1484-1493. doi: 10.1177/1359105317740619. Epub 2017 Nov 15.
PubMed 29139311Nair US, Patterson F, Rodriguez D, Collins BN. A telephone-based intervention to promote physical activity during smoking cessation: a randomized controlled proof-of-concept study. Transl Behav Med. 2017 Jun;7(2):138-147. doi: 10.1007/s13142-016-0449-x.
PubMed 27896797
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking
- ClinicalTrials.gov ID
- NCT02220465
- Acronym / sponsor ID
- 13CRP14560028
- Conditions
- Sedentary Lifestyle, Cigarette Smoking
- Keywords
- sedentary, smoking, cue reactivity, physical activity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's primary aim is to test the hypothesis that an intervention that integrates low to moderate physical activity (walking) with evidence-based smoking cessation counseling (LMPA) will result is greater reductions in quit-day reactivity to smoking cues (a behavioral predictor of smoking relapse) as compared to standard care smoking cessation counseling (control group) in a sample of low-income sedentary male and female smokers. The study will also test the hypothesis that the participants randomized to the LMPA intervention will have greater quit rates at one-week and one-month post quit day follow ups.
Detailed description
Tobacco use and lack of physical activity (PA) are preventable health behaviors contributing to disproportionate rates of morbidity/mortality (MM) among low income underserved adults. Comprehensive interventions incorporating treatment of multiple risk behaviors can have immense public health impact. The goal of this study is to improve uptake of PA during the pre-quit period by promoting low to moderate intensity PA (LMPA/walking) during the pre-quit preparatory period to promote smoking cessation among low-income sedentary smokers. Eligible participants (sedentary, >5 cigs/day) will be randomized to 8-week LMPA vs. standard of care (SCC) intervention. LMPA group intervention focuses on (a) increasing daily steps using a tailored algorithm with a goal of reaching 10,000 steps/day by Week 4 (quit day) and (b) integrates PA with evidence-based smoking cessation programming by explicitly linking short bouts of PA with urge management training during the pre-quit period. The SCC group receives standard care smoking cessation counseling. Group differences in quit day reduction (extinction) of smoking urge reactivity using an analog cue-exposure paradigm, and smoking quit rates at 1-week and 1-month follow-up will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA+ Smoking Cessation (LMPA) | Experimental | Behavioral: PA+ Smoking Cessation (LMPA)This intervention integrates low-to-moderate physical activity (PA) with evidence based smoking cessation programming. Over the 4-week treatment period, the intervention (1 in-person and 3 phone counseling sessions) focuses on (a) gradually increasing routine PA during the pre-quit period and maintaining PA post quit day (b) increasing daily PA (steps/day) using a weekly tailored algorithm with the goal of achieving 10,000 steps by Week 4 (quit day) and (c) training participants to use PA as a primary urge management strategy, thereby embedding PA within evidence-based smoking cessation counseling. Other components include additional smoking urge management skills, increasing motivation to quit, overcoming barriers and maintaining PA for quitting and staying smoke-free . |
| Standard Care Smoking Counseling (SCC) | Active comparator | Behavioral: Standard Care Smoking Counseling (SCC)The control intervention parallels the format of the LMPA intervention with focus only on behavioral and cognitive urge management strategies (avoiding/escaping high-risk situations, stimulus control) and minimizing the probability that participants in the control group would increase increase/use PA during the intervention period. Participants are provided a pedometer without any instructions or encouragement around increasing walking/steps during the 8-week intervention period. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- intent-to-treat sedentary male and female smokers (intention to quit within the next 6 months) - - - smoke 6 or more cigarettes per day.
- Sedentary critieria: not purposeful physical activity for less than 20 minutes of vigorous intensity, or less than 60 minutes of moderate intensity physical activity per week, or less than 100 minutes of time spent walking per week.
Key exclusion criteria (3 listed)
- pregnancy
- current substance abuse (e.g., alcohol, cocaine, or stimulants);
- current diagnosis or treatment of bipolar and psychotic disorder (e.g., use of Haldol, Thorazine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PA+ Smoking Cessation (LMPA) | Behavioural | PA+ Smoking Cessation (LMPA) |
| Standard Care Smoking Counseling (SCC) | Behavioural | Standard Care Smoking Counseling (SCC) |
Primary outcome
Smoking Cue Reactivity on Quit Day
Time frame: 4-weeks
smoking cue reactivity is a behavioral predictor of smoking outcomes. We anticipate that the LMPA intervention will experience greater reductions (extinction) during a controlled, massed cue exposure procedure on their quit day than the Standard care control (SCC) group.
1 secondary outcome
Quit rates at follow ups
Time frame: 7 days prior to 1week and 1 month follow up assessments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
- Derived from this study: PubMed 29139311Nair US, Haynes P, Collins BN. Baseline sleep quality is a significant predictor of quit-day smoking self-efficacy among low-income treatment-seeking smokers. J Health Psychol. 2019 Sep;24(11):1484-1493. doi: 10.1177/1359105317740619. Epub 2017 Nov 15.
- Derived from this study: PubMed 27896797Nair US, Patterson F, Rodriguez D, Collins BN. A telephone-based intervention to promote physical activity during smoking cessation: a randomized controlled proof-of-concept study. Transl Behav Med. 2017 Jun;7(2):138-147. doi: 10.1007/s13142-016-0449-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uma S Nair, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PA+ Smoking Cessation (LMPA) in people with Sedentary Lifestyle and Cigarette Smoking, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uma S Nair, PhD (215-204-6251, uma.nair@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cue Reactivity on Quit Day (time frame: 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02220465, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.