Community Intervention to Reduce Tobacco Use in Pregnant Women


  • Study type

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 13-008824
    NCT ID: NCT02083081
    Sponsor Protocol Number: 13-008824

About this study

In the southwest region of Alaska where the project takes place, 79% of Alaska Native women smoke cigarettes or use smokeless tobacco (ST) during pregnancy. In addition, pregnancy appears to be a high risk period for initiation of tobacco use, primarily ST, among women reporting no use of tobacco 3 months before pregnancy. Intervention efforts targeting the entire community, not only pregnant women, to address social norms about tobacco use may be effective. Thus, the investigators will evaluate the efficacy of a novel, multi-component, theory-based intervention for reducing tobacco use during pregnancy, incorporating both individually targeted and community level components delivered by female elders "Native Sisters." The intervention builds on effective community and individual-based approaches for tobacco cessation and lay health advisor approaches for cancer prevention among Native American women. As part of the intervention, a social marketing campaign including digital stories and other small media will be developed with community feedback. Individually targeted components will be six 30-40 minute telephone or home-based peer counseling sessions with pregnant women.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Alaska Native
  • ≥18 years of age
  • able to provide written informed consent
  • currently pregnant and at < 26 weeks gestation
  • has access to a working telephone.

Exclusion Criteria:

  • plans to have an abortion

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Christi Patten, Ph.D.

Contact us for the latest status

Contact information:

Christi Patten Ph.D.



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