Community Intervention to Reduce Tobacco Use in Pregnant Women
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation, Tobacco Consumers |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 6/7/2018 |
| Start Date: | May 2014 |
| End Date: | April 2019 |
Community Intervention to Reduce Tobacco Use Among Alaska Native Pregnant Women
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.
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.
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.
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.
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
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