Tobacco Cessation Treatment for Pregnant Alaska Natives

NCT ID: NCT00379444

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Standard intervention (counseling + self-help written materials)

counseling

Intervention Type: BEHAVIORAL

Enhanced Intervention (same as standard treatment plus 10-15 min of counseling and a culturally tailored video)

counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Christi Patten

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christi A Patten, P

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

5R01DA025156-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1711-05

Identifier Type: -

Identifier Source: org_study_id