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

Sedentary Lifestyle Clinical Trial

Official title:

Using Physical Activity to Reduce Smoking Cue Reactivity Among Low-Income Smokers Preparing to Quit Smoking

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02220465
• Other study ID #: 13CRP14560028
• Status: Unknown status
• Phase: Phase 1
• First received: August 15, 2014
• Last updated: August 15, 2014
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2014
• Source: Temple University
• Contact: Uma S Nair, PhD
• Phone: 215-204-6251
• Email: uma.nair[@]temple.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 90
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cigarette Smoking
• Sedentary Lifestyle

Intervention

Behavioral:
• PA+ Smoking Cessation (LMPA)

• Standard Care Smoking Counseling (SCC)

Locations

Country	Name	City	State
United States	Temple university	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-weeks
Secondary	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.	7 days prior to 1week and 1 month follow up assessments