Tobacco Cessation Treatment for Pregnant Alaska Natives
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|ClinicalTrials.gov Identifier: NCT00379444|
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : March 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use||Behavioral: Standard intervention (counseling + self-help written materials) Behavioral: Enhanced Intervention (same as standard treatment plus 10-15 min of counseling and a culturally tailored video)||Phase 1 Phase 2|
Tobacco use is the single largest cause of premature and preventable death in the U.S. The prevalence of tobacco use among adults is currently highest among Alaska Natives. Over 50% of Alaska Native women residing in the Yukon-Kuskokwim (Y-K) Delta of western Alaska use smokeless tobacco or smoke cigarettes during pregnancy. Alaska Natives of this region are of Yup'ik or Cup'ik Eskimo, or Athabascan Indian ethnicity. No prior work has evaluated tobacco use interventions for pregnant Alaska Native women.
This proposal builds on our successful partnership and track record of collaboration with Y-K Delta Alaska Natives. The objective of this R21 proposal is to develop and pilot test a novel, culturally-tailored behavioral approach to tobacco cessation for pregnant Alaska Native women. We expect that as a result of this project, we will have developed a replicable, feasible, and acceptable counseling intervention, the efficacy of which can be tested in future larger-scale randomized clinical trials. Social cognitive (learning) theory is the conceptual basis for the proposed intervention.
This project will take place in two phases. In Phase 1, we will develop a multi-component, culturally-tailored, tobacco use intervention with and for Alaska Native pregnant women, including a videotape and telephone counseling. This work will include development of a counselor manual and development of the intervention with focus groups. During this phase, 10 pregnant women will complete the protocol, which will be modified and refined based on feedback from participants and counselors. Phase 2, consisting of a pilot clinical trial, will apply a randomized, two group design with assessments at the first prenatal visit (baseline) and at the last prenatal visit approximately 36 weeks gestation. Pregnant women will be recruited and randomized to either a standard (N=30) or enhanced (N=30) tobacco use intervention. The overall health related objective of this line of research is to develop effective treatment programs with and for Alaska Native pregnant women that will ultimately reduce the risk of tobacco-related disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tobacco Cessation Treatment for Pregnant Alaska Natives|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
- Behavioral: Standard intervention (counseling + self-help written materials)
- Behavioral: Enhanced Intervention (same as standard treatment plus 10-15 min of counseling and a culturally tailored video)
- Tobacco abstinence, feasibility (recruitment and retention), [ Time Frame: end of pregnancy ]
- acceptability of the intervention to the women and providers. [ Time Frame: week 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379444
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Christi A Patten, P||Mayo Clinic|