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Completed

NCT Number: NCT02018640

Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99577, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible the woman must:

  • be Alaska Native
  • be aged 18 years of age or older
  • provide written informed consent
  • have participated in Phase 1 of the research or is currently pregnant (<= 24 weeks gestation)
  • 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:

  • be referred by the woman participant
  • be aged 18 years of age or older
  • provide written informed consent

Exclusion criteria

  • does not provide written informed consent

Treatment and study plan

Primary outcomes

  1. receptivity to cancer risk messages

    Time frame: baseline

    interview of participant reactions to biomarker findings

Secondary outcomes

  1. confidant perceptions of cancer risk information

    Time frame: baseline

    interview of family members, friends, relatives

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Alaska Native Tribal Health Consortium
  • National Cancer Institute (NCI)
  • University of California, San Francisco
  • University of Minnesota

Registry information

Acronym: MAW Phase 2

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2013
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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