NCT01228916

Brief Summary

Tobacco use and tobacco-caused illnesses and death are increasing in developing countries globally, so it is critical to study these countries in order to effectively address the tobacco epidemic. The proposed project will test the effectiveness of community-based interventions for secondhand smoke and quitting smoking in eight underserved communities in the Dominican Republic. The project will also partner with communities and national and international groups to determine whether the methods and interventions from this study in the Dominican Republic can also be used to help other countries in the region and underserved groups in the United States.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

3.4 years

First QC Date

October 25, 2010

Last Update Submit

April 19, 2016

Conditions

Keywords

tobaccosmokingsecondhand smoke

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Tobacco Use

    Self report of current use of any tobacco product

    Yrs 5

Secondary Outcomes (2)

  • Self Reported Exposure to Secondhand Smoke

    Yrs 5

  • Self-Reported Tobacco Use

    Year 4

Study Arms (2)

Tobacco Cessation and Secondhand Smoke Reduction

EXPERIMENTAL

Community based interventions to raise awareness regarding secondhand smoke exposure, clean indoor air laws, smokefree homes, risks of tobacco use and benefits of cessation; include talks, healthcare provider training, radio public service announcements and talk shows, tleevision interviews, cessation classes and individual sessions, health fairs, community marches for smokefree spaces, materials and resources for assisting in tobacco use cessation, estsablishing smokefree homes, adhering to smokefree laws

Behavioral: Tobacco Cessation and Secondhand Smoke Reduction

Delayed Intervention Control

NO INTERVENTION

Assessment only during comparison period (no interventions will be provided over and above any secular trends in communities); delayed intervention will be provided at end of 1 year comparison period

Interventions

Awareness raising and resources for cessation and secondhand smoke reduction

Also known as: tobacco cessation, secondhand smoke, smokefree homes
Tobacco Cessation and Secondhand Smoke Reduction

Eligibility Criteria

Age1 Year - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Atencion Primaria Juan XXIII

Santiago de los Caballeros, Dominican Republic, Dominican Republic

Location

MeSH Terms

Conditions

Tobacco Use CessationSmoking

Interventions

Tobacco Use Cessation DevicesTobacco Smoke Pollution

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsSmokeParticulate MatterComplex MixturesAir PollutionEnvironmental PollutionPublic HealthEnvironment and Public Health

Study Officials

  • Deborah J Ossip, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 27, 2010

Study Start

June 1, 2010

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations