Biomarker Feedback to Motivate Cessation in Pregnancy



Status:Completed
Conditions:Smoking Cessation, Women's Studies, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases, Reproductive
Healthy:No
Age Range:18 - 45
Updated:12/21/2017
Start Date:March 2015
End Date:December 2017

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Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW) - Phase 3 Pilot Clinical Trial

Phase 3 Pilot Clinical Trial.

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 the investigators' successful partnership with the Alaska Native community and previous
work with Alaska Native pregnant women. The investigators 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 the investigators 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, the investigators 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 60 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 the investigators' 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.

This is the third and final phase of the project.

Inclusion Criteria:

- Alaska Native

- 18 years or older

- provide written informed consent

- be currently pregnant and at <24 weeks gestation

- reside in Anchorage and plan to deliver at the ANMC

- current tobacco user defined as any use of Iqmik, commercial ST, and/or cigarettes
during the past 7 days.

Exclusion Criteria:

- use of using nicotine replacement therapy or medications for tobacco cessation or
participation in a behavioral cessation program within the past 30 days

- another woman from the same household has enrolled.
We found this trial at
1
site
Anchorage, Alaska 99508
Principal Investigator: Timothy Thomas, MD
Phone: 907-729-3095
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mi
from
Anchorage, AK
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