Working… Menu

Community Intervention to Reduce Tobacco Use in Pregnant Women (Sisters)

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. Identifier: NCT02083081
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : February 2, 2021
Yukon Kuskokwim Health Corporation
University of Minnesota
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Community level intervention Phase 1 Phase 2

Detailed Description:

The project will be conducted in two phases. In Phase I, the investigators will develop the social marketing components by obtaining qualitative feedback from pregnant women, family members and elders on message content and delivery channels. In Phase II, the investigators will evaluate the intervention using a group-randomized design with village as the unit of assignment. Sixteen villages will be randomly assigned to receive the intervention or control condition (usual care), with > 20 pregnant women enrolled from each village. Assessments will be completed by enrolled women through 6 months postpartum. All aspects of the project will be guided by a Community Advisory Committee.

The Specific Aims are:

Aim 1. To develop and pre-test the social marketing campaign messages and delivery channels through focus groups and individual interviews of pregnant women, family members, and elders. The focus group work will assess reasons for initiating or continuing tobacco use during pregnancy and the potential role of other community members in addressing tobacco use in pregnancy. Findings will be used to develop campaign messages and media that will be pre-tested through individual interviews and refined. Session content for the individually targeted intervention components will also be developed to align with the campaign messages.

Aim 2. To evaluate the efficacy of the intervention compared with the control condition on the biochemically confirmed 7-day point prevalence tobacco use rate at week 36 gestation and at 6 months postpartum.

Hypothesis: Compared with the control condition, the intervention will be associated with significantly lower rates of tobacco use in late pregnancy (80% vs. 65%) and at 6 months postpartum (70% vs. 55%).

Aim 3. To examine the effect of the intervention on proposed social cognitive-theory based mediators of change including perceived social norms about tobacco use and self-efficacy for non-tobacco use.

Hypothesis: Intervention effects on tobacco use at week 36 gestation and at 6 months postpartum will be mediated by perceived self-efficacy and anti-tobacco norms.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community Intervention to Reduce Tobacco Use Among Alaska Native Pregnant Women
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: community intervention
Community level intervention (Social marketing campaign delivered to entire village) plus individual peer counseling sessions for enrolled pregnant women
Behavioral: Community level intervention
Community intervention plus individual counseling

No Intervention: usual care
Usual care provided by health aides to pregnant women

Primary Outcome Measures :
  1. Tobacco use status [ Time Frame: 6 months postpartum ]
    Biochemically verified tobacco use status

Secondary Outcome Measures :
  1. Changes from baseline in self-efficacy for non-tobacco use scores [ Time Frame: 6 months postpartum ]
    Explore changes from baseline in social cognitive theory-based mechanisms of change including self-efficacy for non-tobacco use scores

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02083081

Layout table for location information
United States, Alaska
Yukon Kuskokwim Health Corporation
Bethel, Alaska, United States, 99559
Sponsors and Collaborators
Mayo Clinic
Yukon Kuskokwim Health Corporation
University of Minnesota
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Christi A Patten, PhD Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Christi Patten, PI, Mayo Clinic Identifier: NCT02083081    
Other Study ID Numbers: 13-008824
1R01CA164533 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Christi Patten, Mayo Clinic:
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders