Tobacco Cessation Treatment for Pregnant Alaska Natives

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00379444
First received: September 19, 2006
Last updated: March 8, 2012
Last verified: September 2006
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tobacco Cessation Treatment for Pregnant Alaska Natives

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Tobacco abstinence, feasibility (recruitment and retention), [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]
  • acceptability of the intervention to the women and providers. [ Time Frame: week 6 ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: November 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Standard intervention (counseling + self-help written materials)
    counseling
    Behavioral: Enhanced Intervention (same as standard treatment plus 10-15 min of counseling and a culturally tailored video)
    counseling
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379444

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Christi A Patten, P Mayo Clinic
  More Information

No publications provided

Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00379444     History of Changes
Other Study ID Numbers: 1711-05, 5R01DA025156-03
Study First Received: September 19, 2006
Last Updated: March 8, 2012
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
tobacco, intervention, tobacco cessation, ALaska Natives,
Native Americans, pregnancy, women

ClinicalTrials.gov processed this record on September 18, 2014