Recruiting
Phase 1

Exercise

Sponsor:

Temple University

Code:

NCT02220465

Conditions

Sedentary Lifestyle

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

Interventions

PA+ Smoking Cessation (LMPA)

Standard Care Smoking Counseling (SCC)

Study Details

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.

Conditions

Sedentary Lifestyle

Cigarette Smoking

Study ID

NCT02220465

Start date

Apr, 2013

Status verified date

Jan, 2014

Completion date

Dec, 2015

Anticipated

Primary completion date

Nov, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 59

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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 .

active comparator: 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.

Interventions

PA+ Smoking Cessation (LMPA)

Standard Care Smoking Counseling (SCC)

Primary outcome measure

  • Smoking Cue Reactivity on Quit Day [ Time Frame: 4-weeks ]

Central Contacts and Locations

Central contacts

Locations

Temple university

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

Bradley N Collins, phD

collinsb@temple.edu

Principal Investigator:

Uma S Nair, PhD

More Information

Sponsor

Temple University

Last update posted

Aug 20, 2014

Last verified

Jan, 2014

Keywords

  • sedentary
  • smoking
  • cue reactivity
  • physical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2014-08-20.