Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Smoking Cessation, Women's Studies, Tobacco Consumers |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/21/2017 |
| Start Date: | December 2013 |
| End Date: | August 2015 |
Use of tobacco is very high among Alaska Native pregnant women. The investigators are
conducting a three phase study. The first study is nearly completed and involved measuring
biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a
qualitative study to translate the biomarker findings to an intervention.
conducting a three phase study. The first study is nearly completed and involved measuring
biomarkers of tobacco exposure in mothers and infants. The second phase of the research is a
qualitative study to translate the biomarker findings to an intervention.
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 utilized 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 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 women who use tobacco and
a confidant (partner/friend/relative) they have identified to develop the biomarker feedback
intervention messages. Phase 3 will consist of a formative evaluation of the biomarker
feedback intervention with 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.
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 utilized 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 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 women who use tobacco and
a confidant (partner/friend/relative) they have identified to develop the biomarker feedback
intervention messages. Phase 3 will consist of a formative evaluation of the biomarker
feedback intervention with 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 of age or older
3. provide written informed consent
4. have participated in Phase 1 of the research or is currently pregnant (<= 24 weeks
gestation)
5. have used any tobacco product at least once in the past 7 days (cigarettes or both
cigarettes/ST)
To be eligible the confidant (he/she) must:
1. be referred by the woman participant
2. be aged 18 years of age or older
3. provide written informed consent
Exclusion Criteria:
1. does not provide written informed consent
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