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

This study is currently recruiting participants.
Verified September 2017 by Christi Patten, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02083081
First Posted: March 11, 2014
Last Update Posted: September 6, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Yukon Kuskokwim Health Corporation
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic
  Purpose
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 Intervention Phase
Nicotine Dependence Behavioral: Community level intervention Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Christi Patten, Mayo Clinic:

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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 320
Study Start Date: May 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02083081


Contacts
Contact: Christi A Patten, PhD 507-538-7370 patten.christi@mayo.edu
Contact: Christina M Smith 507-266-2658 smith.christi@mayo.edu

Locations
United States, Alaska
Yukon Kuskokwim Health Corporation Recruiting
Bethel, Alaska, United States, 99559
Contact: Gregory O Thackston, MS, MPA, MHA    907-543-6166    Gregory_Thackston@ykhc.org   
Contact: Rachelle Byrd    907-543-6166    Rachelle Byrd <Rachelle_Byrd@ykhc.org>   
Sub-Investigator: Gregory O Thackston         
Sponsors and Collaborators
Mayo Clinic
Yukon Kuskokwim Health Corporation
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Christi A Patten, PhD Mayo Clinic
  More Information

Responsible Party: Christi Patten, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02083081     History of Changes
Other Study ID Numbers: 13-008824
1R01CA164533 ( U.S. NIH Grant/Contract )
First Submitted: March 5, 2014
First Posted: March 11, 2014
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by Christi Patten, Mayo Clinic:
tobacco
smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders