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Trial record 20 of 32 for:    tribe

Menominee Stop Tobacco Abuse Renew Tradition Study (START)

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ClinicalTrials.gov Identifier: NCT01083654
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : February 1, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborators:
University of Wisconsin, Milwaukee
Menominee Indian Tribe of Wisconsin
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Smoking
Interventions Behavioral: Standard Treatment Counseling
Behavioral: Culturally-Tailored Treatment
Enrollment 103
Recruitment Details Participants were recruited from February 22, 2010, to May 26, 2011 at the Menominee Tribal Clinic (MTC). The MTC Wellness Director or designee screened potential participants (adult American Indian smokers). Informed consent and HIPAA authorization were obtained at the Enrollment Visit.
Pre-assignment Details  
Arm/Group Title Standard Treatment Counseling Culturally-Tailored Treatment
Hide Arm/Group Description

Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w

The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol

Period Title: Overall Study
Started 53 50
Completed 53 50
Not Completed 0 0
Arm/Group Title Standard Treatment Counseling Culturally-Tailored Treatment Total
Hide Arm/Group Description

Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

ST Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by an enrolled member of the Menominee Tribe but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling.

The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)

Total of all reporting groups
Overall Number of Baseline Participants 53 50 103
Hide Baseline Analysis Population Description
Adult American Indian smokers eligible for services at the Menominee Tribal Clinic.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 50 participants 103 participants
39.4  (13.5) 40.1  (12.7) 39.8  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 103 participants
Female
34
  64.2%
30
  60.0%
64
  62.1%
Male
19
  35.8%
20
  40.0%
39
  37.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 103 participants
American Indian or Alaska Native
53
 100.0%
50
 100.0%
103
 100.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 50 participants 103 participants
53 50 103
1.Primary Outcome
Title 7-day Point-prevalence Smoking Abstinence
Hide Description Self-reported abstinence (versus smoking) during the past 7 days at the 6-month follow-up time-point, verified by exhaled breath carbon monoxide (CO) measurement (< 10 parts per million CO is indicative of no smoking).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Treatment Counseling Culturally-Tailored Treatment
Hide Arm/Group Description:

Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w

The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol

Overall Number of Participants Analyzed 53 50
Measure Type: Number
Unit of Measure: Number of abstinent participants
12 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Treatment Counseling, Culturally-Tailored Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .262
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.20 to 1.55
Estimation Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description Medication adverse events were assessed during the 12 weeks of medication use.
 
Arm/Group Title Standard Treatment Counseling Culturally-Tailored Treatment
Hide Arm/Group Description

Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w

The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).

Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol

All-Cause Mortality
Standard Treatment Counseling Culturally-Tailored Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Standard Treatment Counseling Culturally-Tailored Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Treatment Counseling Culturally-Tailored Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/53 (1.89%)      2/50 (4.00%)    
Gastrointestinal disorders     
Stomach pain *  1/53 (1.89%)  1 0/50 (0.00%)  0
Nausea *  0/53 (0.00%)  0 1/50 (2.00%)  1
Psychiatric disorders     
Change in mood *  0/53 (0.00%)  0 1/50 (2.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Stevens S. Smith, Ph.D.
Organization: University of Wisconsin School of Medicine and Public Health
Phone: 608-262-7563
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01083654     History of Changes
Other Study ID Numbers: H-2009-0194
First Submitted: March 8, 2010
First Posted: March 10, 2010
Results First Submitted: December 29, 2015
Results First Posted: February 1, 2016
Last Update Posted: June 17, 2016