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Tobacco Cessation Treatment for Pregnant Alaska Natives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00379444
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):

September 19, 2006
September 21, 2006
March 9, 2012
November 2006
November 2008   (Final data collection date for primary outcome measure)
  • Tobacco abstinence, feasibility (recruitment and retention), [ Time Frame: end of pregnancy ]
  • acceptability of the intervention to the women and providers. [ Time Frame: week 6 ]
  • Tobacco abstinence, feasibility (recruitment and retention),
  • acceptability of the intervention to the women and providers.
Complete list of historical versions of study NCT00379444 on ClinicalTrials.gov Archive Site
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Tobacco Cessation Treatment for Pregnant Alaska Natives
Tobacco Cessation Treatment for Pregnant Alaska Natives
This study will develop a culturally appropriate tobacco cessation behavioral intervention for Alaska Native women who are pregnant and who use tobacco. We will examine the feasibility of the intervention in terms of recruitment and retention of participants, acceptability to patients and prenatal health care providers, and the potential effectiveness of the tobacco use intervention.

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.

Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
November 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

For pilot testing of the intervention, we will recruit 70 Alaska Native adult pregnant women (10 in Phase 1, 60 in Phase 2) at their first prenatal visit. To be eligible, the participant must: (1) be 18 years of age or older, (2) provide written informed consent, (3) be willing and able to participate in all aspects of the study, (4) be <24 weeks pregnant, (4) self-report any use of Iqmik, commercial ST, and/or cigarette smoking during the past 7 days, (5) plan to make a serious attempt to stop tobacco use within the next 30 days, (6) have access to a working telephone or provide phone number of a family member, and (7) have access to a working television and VCR in the home or other location.

Exclusion Criteria:

Women will be excluded if: (1) they are currently (past 30 days) participating in any tobacco treatment or (2) if there is another study participant from the same household.

Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
5R01DA025156-03 ( U.S. NIH Grant/Contract )
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Christi Patten, Mayo Clinic
Mayo Clinic
National Institute on Drug Abuse (NIDA)
Principal Investigator: Christi A Patten, P Mayo Clinic
Mayo Clinic
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP