Community Intervention to Reduce Tobacco Use in Pregnant Women
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

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.
    

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.
    

Intervention name(s): Community level intervention
Intervention type(s): Behavioral
Intervention description(s): Community intervention plus individual counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tobacco; smoking