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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00059514
Other study ID # 5R01HD37498-3
Secondary ID
Status Completed
Phase N/A
First received April 28, 2003
Last updated April 3, 2017
Start date May 2000
Est. completion date May 2006

Study information

Verified date April 2017
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Michigan has the 10th highest smoking rate in the nation. Smoking rates are also very high in the Middle East and in Arab American families. The purpose of this study is to learn about tobacco use in Michigan Arab American youth ages 14 to 18. The study will evaluate why some young people start smoking and others do not. The study will also test an educational program designed to encourage young people to either quit tobacco use or to avoid it.


Description:

Cigarette smoking is the chief avoidable cause of death and disease in Michigan, the United States, and the world. In 1996, 25.9% of the Michigan adult population smoked cigarettes; Michigan has the 10th highest smoking rate in the nation. When the indirect costs of lost income due to smoking-related illnesses and premature death are added to the cost of medical care, tobacco use costs Michigan citizens more than $2.6 billion per year (Michigan Department of Community Health (MDCH), 1996). Contributing to tobacco use statistics in Michigan is a rapidly growing Arab American immigrant population. Studies have shown cigarette smoking rates in Middle-Eastern adolescents range from 33% to 58%. This study will examine cultural, personal, social, and environmental forces operating in Arab American youths at risk for habitual tobacco use. The study will also test the effects of a smoking cessation/prevention intervention on smoking behavior.

The settings for this study are the Arab Community Center for Economic and Social Services (ACCESS) Teen Health Center, which services almost 2,500 youth visits each year, and local high schools with a significant population of Arab American youth. The majority of the people served by the clinic are poor, under-educated, live in extended families of 3 to 5 adults, are immigrants, and speak Arabic as a first language. A total of 4,000 adolescents over 14 years old will be asked to provide information on demographic and cultural variables, self-esteem, stress, family and peer tobacco use, intention to use tobacco, history of tobacco use, initial stage of change, and perceived health.

Youths with the highest risk for tobacco use will be randomly assigned to either a Modified Project Toward No Tobacco Use (Project TNT) intervention or a wait list control group. Project TNT, the precursor to the Arab American-specific modified Project TNT, was designed to target the primary causes of tobacco use among adolescents and has been shown to be effective in diverse cultural groups. The modified Project TNT consists of weekly 40-minute sessions with a health educator over 4 weeks. Bilingual health educators will deliver the intervention in a small group (four to six adolescents) or classroom context. Follow-up data will be collected at 3, 6, and 12 months after the program is completed. Youth assigned to the wait list control group will participate in the modified Project TNT after the Month 6 follow-up data is collected from the first group.


Recruitment information / eligibility

Status Completed
Enrollment 2300
Est. completion date May 2006
Est. primary completion date April 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria

- 14-18 years

- Self-identify as Arab American

- Attendee of a teen health clinic or high school

Exclusion Criteria

- older than 18 years

- does not identify as Arab or Arab American

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Modified Project Toward No Tobacco Use


Locations

Country Name City State
United States Arab American Center for Economic & Social Services Dearborn Michigan

Sponsors (1)

Lead Sponsor Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

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