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

NCT02220465 | Unknown Phase 1

• 1 other identifier: 13CRP14560028
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

sedentary; smoking; cue reactivity; physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quit rates at follow ups

  7 days prior to 1week and 1 month follow up assessments

Study Arms (2)

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 .

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.

Behavioral: Standard Care Smoking Counseling (SCC)

Interventions

PA+ Smoking Cessation (LMPA) BEHAVIORAL

PA+ Smoking Cessation (LMPA)

Standard Care Smoking Counseling (SCC) BEHAVIORAL

Standard Care Smoking Counseling (SCC)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Temple university

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 29139311 DERIVED

• 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.

  PMID: 27896797 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Cigarette Smoking; Smoking; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Uma S Nair, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uma S Nair, PhD

CONTACT

215-204-6251; uma.nair@temple.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2014
• First Posted: August 20, 2014
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2015
• Last Updated: August 20, 2014

Record last verified: 2014-01

Locations

US (1)