Tobacco Use DisorderNCT00059514
Tobacco Use Among Arab American Youth
An observational study of Tobacco Use Disorder, run by Wayne State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Modified Project Toward No Tobacco Use
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,300 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to May 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 2300 + school-based Arab American adolescents (14-18 years) were recruited for participation in this study of tobacco use. 1700 students provided detailed health and tobacco use histories. 616 students were assigned by classroom to a smoking cessation intervention or to a class on health.
Who may be able to join
- 14-18 years
- Self-identify as Arab American
- Attendee of a teen health clinic or high school
Who cannot join
- older than 18 years
- does not identify as Arab or Arab American
Trial locations and contacts
1 site in 1 country.
United States1 site
Arab American Center for Economic & Social Services
Dearborn, Michigan, 48124
About this study
Official title: Arab American Youth: Tobacco Use and Intervention
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.
Read the detailed 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Modified Project Toward No Tobacco Use
- Keywords
- Youth, Adolescents, Smoking cessation, Smoking prevention, Risk factors, Arab Americans
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Project Toward No Tobacco UseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2003 (estimated)
- Study startMay 2000
- Primary completionApr 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginia H. Rice, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Virginia H Rice, PhD, RN, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059514
- Sponsor's protocol ID
- 5R01HD37498-3
- Other IDs
- 5R01HD037498
- Status last verified
- Apr 2017
- First submitted
- 28 Apr 2003
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arab American Youth: Tobacco Use and Intervention
- ClinicalTrials.gov ID
- NCT00059514
- Acronym / sponsor ID
- 5R01HD37498-3
- Conditions
- Tobacco Use Disorder
- Keywords
- Youth, Adolescents, Smoking cessation, Smoking prevention, Risk factors, Arab Americans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,300 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- May 2000 (actual)
- Primary completion
- Apr 2005 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 29 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 2300 + school-based Arab American adolescents (14-18 years) were recruited for participation in this study of tobacco use. 1700 students provided detailed health and tobacco use histories. 616 students were assigned by classroom to a smoking cessation intervention or to a class on health.
Key inclusion criteria (3 listed)
- 14-18 years
- Self-identify as Arab American
- Attendee of a teen health clinic or high school
Key exclusion criteria (2 listed)
- older than 18 years
- does not identify as Arab or Arab American
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Project Toward No Tobacco Use | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use Disorder
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia H Rice, PhD, RN principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use Disorder, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.