Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women

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.

Inclusion Criteria:

To be eligible the woman must:

1. be Alaska Native,

2. be aged 18 years or older,

3. provide written informed consent,

4. be currently pregnant (1st, 2nd or 3rd trimester), and

5. plan to deliver at the ANMC. An additional inclusion criterion for current tobacco
users is any use in the past 7 days. Our preliminary studies indicate that women may
use more than one form of tobacco. To enhance feasibility of recruitment and
generalizability, women will not be excluded if they use more than one form of
tobacco. Instead, group composition will be based on the primary type of tobacco used.
An additional inclusion criterion for non-tobacco users is no use of any form of
tobacco in the last 6 months.

Exclusion Criteria:

1. Women will be excluded if they have used nicotine replacement therapy (NRT) or have
participated in a behavioral or pharmacological tobacco cessation program within the
past 30 days.

2. Alcohol and other drug use will not be an exclusionary criterion because the
biomarkers are specific to tobacco exposure.