Move To Quit - Using Physical Activity to Facilitate Smoking Cessation Among African American Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01915810
First received: August 1, 2013
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

The goal of this research study is to better understand if taking part in physical activity might help smokers quit.


Condition Intervention
Tobacco Use Cessation
Behavioral: Questionnaires
Behavioral: Phone Counseling
Other: Breath Test
Other: Walking Program
Drug: Nicotine Patch
Behavioral: Audio Recorded Focus Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Using Physical Activity to Facilitate Smoking Cessation Among African American Adults

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Feasibility of Smoking Cessation with Physical Activity (SCwPA) Among African American (AA) Smokers [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
    Recruitment feasibility will be achieved if >75% of eligible/screened participants choose to enroll in the study.


Estimated Enrollment: 45
Study Start Date: January 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Physical Activity
Group 1 will not include any physical activity. Visits made to Windsor Village United Methodist Church 9 times on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking. During each visit questionnaires completed, along with a breath test to check for tobacco consumption. At 4 of the visits, height, weight, and waist and hip circumference measured. At 3 of these visits, heart rate also tested. Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day, and a 6-week supply of the nicotine patch. Accelerometer worn 3 weeks before quitting smoking through 4 weeks after the quit day. Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
Behavioral: Questionnaires
Questionnaire completion on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
Other Name: Surveys
Behavioral: Phone Counseling
Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day.
Other: Breath Test
Breath test administered to check for tobacco consumption weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
Drug: Nicotine Patch
6-week supply of the nicotine patch given to participants. Patch dosage congruent with pre-quit smoking rate and will taper over time.
Behavioral: Audio Recorded Focus Group
Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
Active Comparator: Physical Activity 2 Weeks Pre-Quit
Group 2 starts a walking program 2 weeks before their quit day and finish it 2 weeks after their quit day. Visits made to Windsor Village United Methodist Church 9 times on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking. During each visit questionnaires completed, along with a breath test to check for tobacco consumption. At 4 of the visits, height, weight, and waist and hip circumference measured. At 3 of these visits, heart rate also tested. Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day, and a 6-week supply of the nicotine patch. Accelerometer worn 3 weeks before quitting smoking, through 4 weeks after the quit day. Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
Behavioral: Questionnaires
Questionnaire completion on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
Other Name: Surveys
Behavioral: Phone Counseling
Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day.
Other: Breath Test
Breath test administered to check for tobacco consumption weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
Other: Walking Program

Group 2 start a walking program 2 weeks before their quit day and finish it 2 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week.

Group 3 start a walking program on their quit day and finish it 4 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week.

Drug: Nicotine Patch
6-week supply of the nicotine patch given to participants. Patch dosage congruent with pre-quit smoking rate and will taper over time.
Behavioral: Audio Recorded Focus Group
Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
Active Comparator: Physical Activity Beginning on Quit Day
Group 3 starts walking program on their quit day and finish it 4 weeks after their quit day. Visits made to Windsor Village United Methodist Church 9 times on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking. During each visit questionnaires completed, along with a breath test to check for tobacco consumption. At 4 of the visits, height, weight, and waist and hip circumference measured. At 3 of these visits, heart rate also tested. Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day, and a 6-week supply of the nicotine patch. Accelerometer worn 3 weeks before quitting smoking, through 4 weeks after the quit day. Participants take part in a final audio recorded focus group 8 weeks after quitting smoking.
Behavioral: Questionnaires
Questionnaire completion on Weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
Other Name: Surveys
Behavioral: Phone Counseling
Patients receive counseling about quitting smoking over the phone about 1 - 2 weeks before scheduled quit day.
Other: Breath Test
Breath test administered to check for tobacco consumption weeks 3, 2, and 1 before quitting smoking, on quit day, and weeks 1, 2, 3, 4, and 8 after quitting smoking.
Other: Walking Program

Group 2 start a walking program 2 weeks before their quit day and finish it 2 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week.

Group 3 start a walking program on their quit day and finish it 4 weeks after their quit day. Participants walk about 150 minutes (about 2 ½ hours) a week.

Drug: Nicotine Patch
6-week supply of the nicotine patch given to participants. Patch dosage congruent with pre-quit smoking rate and will taper over time.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. self-reported African-American race
  2. age 21-65
  3. current daily smoker (has smoked >=100 cigarettes in lifetime per self-report, smoked >=5 cigarettes per day for the last 6 months per self-report
  4. self-reports motivation to quit smoking within the next 2 weeks
  5. reports willingness to engage in a physical activity-based smoking cessation intervention
  6. has a home address and a functioning home and/or cell phone number
  7. able to engage in moderate intensity physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) if currently taking medication for blood pressure or diabetes.
  8. willingness to wear the nicotine patches provided in the study as recommended
  9. have an expired carbon monoxide (CO) level >/8 parts per million (ppm) suggestive of current smoking
  10. blood pressure </=140/90mm or by physicians clearance (letter from physician or nurse practitioner) if blood pressure reading >140/90mm Hg.

Exclusion Criteria:

  1. contraindication for nicotine patch use
  2. regular use of tobacco products other than cigarettes in the last 30 days (including black & milds)
  3. current or planned future use of any nicotine replacement or pharmacological product for smoking cessation other than the study patches
  4. pregnancy or lactation
  5. another household member enrolled in the study
  6. a schedule not accommodating to the study procedures, or unwillingness to adhere to the procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915810

Contacts
Contact: Crystal L. Roberson, MPH 713-794-1074

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Lorna H. McNeill, PHD, MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01915810     History of Changes
Other Study ID Numbers: 2013-0183
Study First Received: August 1, 2013
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
African American cigarette smoker
Tobacco Use Cessation
Smoking Cessation with Physical Activity
SCwPA
Cancer Prevention
Questionnaires
Surveys
Phone Counseling
Breath Test
Walking Program
Nicotine Patch
Audio Recorded Focus Group

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014