Trial Information

Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women: Phase 1

Developing effective tobacco cessation interventions during pregnancy for American Indian
and Alaska Native people is a national priority and will contribute to the U.S. public
health objective of reducing tobacco-related cancer health disparities. The proposed project
builds on our successful partnership with the Alaska Native community and previous work with
Alaska Native pregnant women. We propose to develop and test a novel biomarker feedback
intervention relating cotinine levels in the urine of pregnant women with the woman and
infant's likely exposure to the tobacco specific nitrosamine and carcinogen
4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be
conducted in three phases. In Phase 1 we will utilize a non-randomized, clinical
observational trial to examine biomarkers of nicotine and carcinogen exposure (urine
cotinine and total NNAL [a metabolite of NNK], respectively) among 150 maternal-infant pairs
with assessments conducted during pregnancy and at delivery. In Phase 2, we will obtain
qualitative feedback on the findings from Phase 1 through individual interviews conducted
with 32 women who use tobacco to develop the biomarker feedback intervention messages.
Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with
80 pregnant women using a two-group randomized design to assess the intervention's
feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of
pregnancy. All phases of the project will be guided by a Community Advisory Committee.
Each phase is an important step to advance our understanding of the potential for biomarker
feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential
reach of the intervention is significant from a public health perspective as over 600
tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the
proposed project will take place. Developing effective interventions for tobacco cessation
during pregnancy is important to reduce adverse health consequences for the mother and
neonate and future risk of tobacco-caused cancers.