Clinical trial NCT02220465: Step-up to Quit: Using Low-to-moderate Intensity Exercise for Reducing Smoking Cue Reactivity Among Low-income Smokers
Official title: Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Sedentary Lifestyle
Cigarette Smoking
Keywords: sedentary
smoking
cue reactivity
physical activity
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Smoking Cue Reactivity on Quit Day
timeFrame: 4-weeks
Secondary outcomes:
measure: Quit rates at follow ups
timeFrame: 7 days prior to 1week and 1 month follow up assessments
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple university
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Uma S Nair, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Nair 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.