Community Intervention to Reduce Tobacco Use in Pregnant Women (Sisters)
|ClinicalTrials.gov Identifier: NCT02083081|
Recruitment Status : Active, not recruiting
First Posted : March 11, 2014
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Behavioral: Community level intervention||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||352 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Community Intervention to Reduce Tobacco Use Among Alaska Native Pregnant Women|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
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
- Tobacco use status [ Time Frame: 6 months postpartum ]Biochemically verified tobacco use status
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083081
|United States, Alaska|
|Yukon Kuskokwim Health Corporation|
|Bethel, Alaska, United States, 99559|
|Principal Investigator:||Christi A Patten, PhD||Mayo Clinic|