NCT00403312

Brief Summary

Cigarette smoking is the most common risk factor for lung cancer, and it increases the risk of developing other cancers, chronic lung disease, and heart disease. A smoking cessation program that incorporates physical activity may be beneficial in improving long-term smoking cessation rates. This study will evaluate the effectiveness of a community-based physical activity program, in combination with nicotine replacement therapy and a behavioral smoking cessation program, at improving cessation rates among sedentary smokers.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
Last Updated

July 2, 2008

Status Verified

June 1, 2008

First QC Date

November 22, 2006

Last Update Submit

June 30, 2008

Conditions

Smoking Cessation

Keywords

Physical ActivityWellness ProgramsPharmacological Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Smoking status (measured immediately post-intervention and at 6- and 12-month follow-up visits)

Secondary Outcomes (4)

  • Changes in self-reported and objective physical activity

  • Body mass index

  • Percentage of body fat

  • Waist circumference (all measured immediately post-intervention and at 6- and 12-month follow-up visits)

Interventions

Smoking Cessation Behavioral ProgramBEHAVIORAL
Nicotine PatchDRUG
Physical ActivityBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smokes five or more cigarettes each day in the year prior to study entry
  • Sedentary or minimally active physical activity level
  • Willing to be randomly assigned to either intervention group
  • Willing to use the nicotine patch

You may not qualify if:

  • Pregnant, breastfeeding, or planning to become pregnant in the year following study entry
  • Planning to move out of the area in the year following study entry
  • Blood pressure greater than 160/95 mm Hg
  • Body weight greater than 140% of ideal body weight
  • History of heart attack, stroke, unstable angina, coronary artery bypass grafting, angioplasty, or stent in the 6 months prior to study entry
  • Symptomatic peripheral artery disease
  • History of congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)
  • Electrocardiogram (EKG) evidence of 2nd or 3rd degree atrioventricular (AV) block
  • History of a serious illness that might limit longevity (e.g., significant kidney disease, liver disease, cancer)
  • Current substance abuse
  • Current alcohol use of more than 21 drinks per week
  • Uncontrolled arrhythmia or hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Memphis Center for Community Health

Memphis, Tennessee, 38152, United States

Location

Department of Preventive Medicine, University of Tennessee Health Science Center

Memphis, Tennessee, United States

Location

Related Publications (1)

  • Stockton MB, Ward KD, McClanahan BS, Vander Weg MW, Coday M, Wilson N, Relyea G, Read MC, Connelly S, Johnson KC. The Efficacy of Individualized, Community-Based Physical Activity to Aid Smoking Cessation: A Randomized Controlled Trial. J Smok Cessat. 2023 May 26;2023:5535832. doi: 10.1155/2023/5535832. eCollection 2023.

    PMID: 37273658DERIVED

MeSH Terms

Conditions

Smoking CessationMotor Activity

Interventions

Tobacco Use Cessation DevicesExercise

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kenneth D. Ward, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

January 1, 2003

Last Updated

July 2, 2008

Record last verified: 2008-06

Locations

US(2)