We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
Trial record 2 of 12 for:    (arctic OR alaska) AND (native OR tribal) AND (woman OR women OR female)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02018640
Recruitment Status : Completed
First Posted : December 23, 2013
Last Update Posted : December 19, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Cancer Tobacco Use Pregnancy

Detailed Description:
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.

Study Design

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2
Study Start Date : December 2013
Primary Completion Date : August 2015
Study Completion Date : August 2015
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. receptivity to cancer risk messages [ Time Frame: baseline ]
    interview of participant reactions to biomarker findings

Secondary Outcome Measures :
  1. confidant perceptions of cancer risk information [ Time Frame: baseline ]
    interview of family members, friends, relatives

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Alaska Native women and their confidants

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018640

United States, Alaska
Alaska Native Tribal Health Consortium
Anchorage, Alaska, United States, 99577
Sponsors and Collaborators
Mayo Clinic
Alaska Native Tribal Health Consortium
University of California, San Francisco
University of Minnesota - Clinical and Translational Science Institute
National Cancer Institute (NCI)
More Information

Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02018640     History of Changes
Other Study ID Numbers: 11-001144 Phase 2
U54CA153605 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

Keywords provided by Christi Patten, Mayo Clinic:
tobacco use