- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01651611
Intervention Study to Increase Smoking Cessation Rates Among Public Housing Residents
August 26, 2016 updated by: Boston University
Health Advocates as a Vehicle to Improve Treatment for Smokers in Public Housing
The purpose of this study is to determine whether public housing residents trained in Tobacco Cessation and Motivational Interviewing Techniques to become Tobacco Treatment Advocates(TTA) will be effective in increasing the quit rate of smokers in Boston Public Housing.
The investigators hypothesize that smokers that receive multiple TTA visits will be more likely to (1) use smoking cessation resources and (2) quit compared to smokers who receive a single visit.
Study Overview
Status
Completed
Conditions
Detailed Description
The study is a group-randomized trial in which 10 pubic housing developments (PHDs) are randomized to the experimental condition and 10 to the control condition.
All smokers who enroll in the study at a particular PHD receive the same intervention.
Smokers at control sites receive written materials that offer strategies for quitting and information about availability of treatment programs, as well as a one-time meeting with a Tobacco Treatment Advocate (TTA).
The intervention group receives the same written materials but also has much more extensive interactions with a TTA.
TTAs provide peer counseling (Peer Counseling is defined as: performance of limited counselor functions, under counselor supervision, by person of similar age,gender, race, ethnicity and/or SES of the counselee) to smokers during in- person Motivational Enhancement meetings (target range 7-9) as well as additional in person and phone contacts, as needed for each participant, over a 6-month period.
TTAs receive intensive training in motivational interviewing and smoking cessation counseling deliver the intervention components (counseling activities and provision of environmental supports) in addition to encouraging utilization of smoking cessation treatment programs such as the Smokers' QuitLine (SQL) and clinic-based programs.
In order to avoid the potential for contamination due to TTAs interacting with participants at both intervention and control sites, meetings with participants at control sites are conducted by special Control TTAs.
Data are collected from study participants at baseline, 3 months, 7 months and 12 months, and also from the SQL and clinics.
Study Type
Interventional
Enrollment (Actual)
330
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston University School of Public Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current smoker, defined as having smoked in last 100days
- Housing Sites: Sites are eligible for the study if they have 50+ smokers determined by synthetic estimates based on citywide survey data.
- Age 18-79
- Current everyday or someday smokers
- Planning to quit smoking in 30 days or thinking about quitting in next 6 months,
- Have smoked 100 cigarettes in lifetime
- Speak English or Spanish
- Plan to live in Public Housing for next 12 months
- Able and willing to provide consent
Exclusion Criteria:
- Smokers less than 18 years of age at time of consent.
- Unable to communicate orally in English or Spanish.
- Currently using pharmacological treatment for smoking cessation
- Currently working with the Smokers Quitline or other Community Health Center based cessation program
- Cognitive/ psychiatric conditions that would interfere with ability to understand and participate in the study
- Have been abstinent for 7 or more days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Extensive TTA interaction
Persons interested in quitting smoking will receive multiple in-person visits from a peer Tobacco Treatment Advocate (TTA) who will provide motivational interviewing, basic smoking cessation counseling assistance, navigation to smoking cessation resources, and social support.
|
The TTA will use motivational interviewing (MI) techniques to assess the participant's motivation and readiness to quit, suggest plans, and assist the participant in selecting a method of treatment.
The TTA will provide information to the participant regarding evidence-based treatments for smoking cessation, including counseling and nicotine replacement therapy (NRT); assist in a quit plan; and discuss issues such as obtaining social support, staying in treatment, and dealing with lapses.
The TTA will assist participants in obtaining NRT and getting connected to smoking cessation counseling services, such as the Smokers' Quitline and clinic-based programs.
Meetings with the TTA will be a source of social support for the participant as they attempt to quit or stay quit.
|
Active Comparator: Minimal TTA interaction
Persons interested in quitting smoking will receive a single in-person visit from a peer Tobacco Treatment Advocate (TTA) who will provide basic smoking cessation counseling assistance.
|
The TTA will provide information to the participant regarding evidence-based treatments for smoking cessation, including counseling and nicotine replacement therapy (NRT); assist in a quit plan; and discuss issues such as obtaining social support, staying in treatment, and dealing with lapses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point prevalence smoking abstinence
Time Frame: 7 months
|
7 and 30-day abstinence from smoking by self-report with verification by carbon monoxide breath test
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilization of smoking cessation resources
Time Frame: 7 months
|
Use of SQL, smoking cessation programs at health clinics or hospitals, physician counseling
|
7 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication use
Time Frame: 3 months, 7 months, 12 months
|
Use of nicotine replacement therapy and/or other smoking cessation medications
|
3 months, 7 months, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel R Brooks, DSc, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
July 24, 2012
First Submitted That Met QC Criteria
July 26, 2012
First Posted (Estimate)
July 27, 2012
Study Record Updates
Last Update Posted (Estimate)
August 29, 2016
Last Update Submitted That Met QC Criteria
August 26, 2016
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H-28386
- 1R01CA141587-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tobacco Cessation
-
University of MiamiFlorida Department of HealthRecruitingSmoking Cessation | Tobacco Smoking | Tobacco Use CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
University of OklahomaCompletedTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency ManagementUnited States
-
University of OklahomaEnrolling by invitationTobacco Cessation | Tobacco Use | Tobacco Smoking | Smoking Cessation Financial Incentives | Socioeconomic Status | Contingency Management | PregnancyUnited States
-
University of MinnesotaCompletedSmoking Cessation | Tobacco CessationUnited States
-
Uppsala UniversityKarolinska Institutet; The Swedish Research Council; Region Stockholm; Swedish... and other collaboratorsTerminatedSmoking Cessation | Tobacco CessationSweden
-
HealthPartners InstituteMinnesota Partnership for Action Against TobaccoCompleted
-
Bispebjerg HospitalAarhus University Hospital Skejby; Rigshospitalet, Denmark; Danish Cancer SocietyCompletedCancer | Tobacco Cessation | Tobacco Smoking
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Food and Health Bureau, Hong Kong; Queen... and other collaboratorsCompletedSmoking Cessation | Tobacco Use CessationHong Kong
Clinical Trials on Motivational interviewing
-
Massachusetts General HospitalRecruitingDiabetes Mellitus, Type 2United States
-
University of Maryland, BaltimoreMaryland Department of Health and Mental HygieneCompletedFractures, Bone | Smoking, TobaccoUnited States
-
Johns Hopkins UniversityZanvyl and Isabelle Krieger FundCompleted
-
Massachusetts General HospitalCompletedACS - Acute Coronary SyndromeUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
Qazvin University Of Medical SciencesCompletedObesity, AdolescentIran, Islamic Republic of
-
Veterans Medical Research FoundationThe Tug McGraw FoundationCompleted
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI); University of Iowa; American... and other collaboratorsCompletedChildhood ObesityUnited States
-
University of StellenboschUniversity of British Columbia; McMaster UniversityCompletedText Messaging Plus Motivational Interviewing in Promotion of Breastfeeding Among HIV-infected WomenHIV Infections | Breast FeedingSouth Africa
-
Centre Hospitalier Universitaire, AmiensRecruitingChronic Disease | Motivational InterviewingFrance