Project CASA: Promoting Smoke-Free Indoor Air Policy in Mexican American Households
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Purpose
Objectives:
Exposure to secondhand smoke (SHS) is a major public health problem in the United States. Studies conducted in this country and internationally have irrefutably shown the causal role of passively inhaled cigarette smoke in development and exacerbation of acute and chronic diseases.
The intervention will be delivered primarily in the form of fotonovelas based on smoking cessation programs previously developed, and the national telephone quit line specifically designed to serve Latino users. The intervention addresses the needs of Mexican American families (youth, middle-aged, and older adults). The evaluation study will be a randomized, controlled trial with assessments at baseline and at 6 and 12 months post-treatment. Up to 125 households will be recruited from the established cohort of Mexican American households located in the Houston metropolitan area.
The objectives for this study are as follows:
1. Reduction in secondhand smoke exposure: The study will distinguish if a tailored intervention designed to address the needs of the target group will reduce objectively and subjectively measured secondhand smoke exposure of nonsmokers in MA households.
1a. Develop tailored Fotonovelas for intervention implementation
2. Smoking cessation: The study will identify if a tailored intervention designed to address the needs of the target group will help the primary smokers in the household quit smoking.
3. Stages of change: The study will identify if the proposed intervention will have a significant impact on the primary smoker(s) progression through the stages of smoking cessation.
4. Knowledge and attitudes: The study will identify if the proposed intervention will result in better knowledge and changed attitudes towards secondhand smoke exposure among members of MA households (smokers and nonsmokers) compared to standard care.
5. Perceived health: The study will distinguish whether reduced exposure to secondhand smoke would improve perceived health.
| Condition | Intervention |
|---|---|
|
Cancer |
Behavioral: Printed Materials Behavioral: Fotonovelas |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Project CASA: Promoting Smoke-Free Indoor Air Policy in Mexican American Households |
- Monitoring Secondhand Smoke (SHS): Nicotine Exposure Levels [ Time Frame: Baseline and 6 Month Follow Up, up to 12 months ] [ Designated as safety issue: No ]SHS exposure based on objective monitoring of SHS in each household (in the kitchen and TV room) over a 7-day period. Passive nicotine monitor used in each home to measure exposure to nicotine which is commonly used as a marker for SHS exposure, and validate self-reported smoking. The method of analysis will be a pre-post test analysis of covariance, ANCOVA, using a linear regression model (PROC REG in SAS).
| Enrollment: | 168 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Intervention Tools + Materials for Smokers |
Behavioral: Printed Materials
Pamphlets: Specific materials for non-smokers and motivated/not motivated smokers. Illustrated storybooks.
|
| Intervention Tools + Materials for Non-Smokers |
Behavioral: Printed Materials
Pamphlets: Specific materials for non-smokers and motivated/not motivated smokers. Illustrated storybooks.
|
Detailed Description:
If you choose to take part in this behavioral study, each household will be randomly assigned to one of 2 study groups. Each study group will receive a different set of learning tools. You will have an equal chance of being assigned to each group.
During Visit 1, researchers will come to your home and explain the study. You will receive a detailed description of the project's goals and procedures. The study staff member will ask you a series of questions to find out about the people who live in your home. The interview will take about 40-50 minutes. Project staff will set up 2 air quality monitors in your home. Each monitor is about the size of a deck of cards. The monitors will be used to measure the air quality in the home.
During Visit 2 (about 1 week after Visit 1), the air quality monitors will be collected. Both participating adult members of the household will be surveyed (on a laptop computer) about their lifestyle habits. This will take about 30-40 minutes. In addition, learning tools will be provided.
About 6 months later, you will have 2 more follow-up visits. During Visit 3, project staff will again set up 2 new air quality monitors in your home. Seven (7) days later (Visit 4), project staff will return to the home to collect the monitors. The same participating adult members of the household will be surveyed again (on a laptop computer) about their lifestyle habits. This will take about 30-40 minutes.
In another 6 months (12 months from the start of the study), you will have the last 2 follow-up visits. During Visit 5, project staff will again set up 2 air quality monitors in your home. Seven (7) days later (Visit 6), project staff will return to your home to collect the monitors. The same participating adult members of the household will be surveyed again (on a laptop computer) about their lifestyle habits. This will take about 30-40 minutes. At the end of this visit, you will have completed the study. Up to 125 households will take part in this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study smoke-free indoor air policy of Mexican American households in Houston Metropolitan area.
Inclusion Criteria:
- Live in the targeted Mexican American neighborhoods.
- Can read Fotonovelas in English and Spanish.
- Access to telephone.
- Smoker in household (Adult (18+) person living in the household who smokes INSIDE at least one cigarette a week)
Exclusion Criteria:
- None other than not meeting inclusion criteria.
- Is there an age limit? No
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Alex Prokhorov, MD, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00850954 History of Changes |
| Other Study ID Numbers: | 2006-0440 |
| Study First Received: | February 24, 2009 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Lung Cancer Cancer Smoke Mexican American Indoor Air Policy Secondhand smoke SHS |
Smoking cessation programs Smokers Tobacco Nicotine Chronic diseases Transtheoretical model of change TTM |
ClinicalTrials.gov processed this record on June 18, 2013