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

50 Years
Open (Enrolling)
Cancer, Tobacco Use, Pregnancy

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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.

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

April 2014

Related Keywords:

  • Cancer
  • Tobacco Use
  • Pregnancy
  • cancer
  • tobacco use
  • pregnancy



Alaska Native Tribal Health ConsortiumAnchorage, Alaska  99577