Step-up to Quit: Using Low-to-moderate Intensity Exercise for Reducing Smoking Cue Reactivity Among Low-income Smokers

NCT ID: NCT02220465

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-12-31

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.

Conditions

Sedentary Lifestyle; Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 .

Group Type: EXPERIMENTAL

PA+ Smoking Cessation (LMPA)

Intervention Type: 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.

Group Type: ACTIVE_COMPARATOR

Standard Care Smoking Counseling (SCC)

Intervention Type: BEHAVIORAL

Interventions

PA+ Smoking Cessation (LMPA)

Intervention Type: BEHAVIORAL

Standard Care Smoking Counseling (SCC)

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uma S Nair, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

Temple university

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Uma S Nair, PhD

Role: CONTACT

uma.nair@temple.edu

215-204-6251

Facility Contacts

Uma Nair, PhD

Role: primary

uma.nair@temple.edu

215-204-6251

Bradley N Collins, phD

Role: backup

collinsb@temple.edu

References

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.

Reference Type: DERIVED

PMID: 29139311 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27896797 (View on PubMed)

Other Identifiers

13CRP14560028

Identifier Type: -

Identifier Source: org_study_id