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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Collaborators:
Alaska Native Tribal Health Consortium
University of California, San Francisco
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Christi Patten, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02018640
First received: December 17, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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
Cancer
Tobacco Use
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • receptivity to cancer risk messages [ Time Frame: baseline ] [ Designated as safety issue: No ]
    interview of participant reactions to biomarker findings


Secondary Outcome Measures:
  • confidant perceptions of cancer risk information [ Time Frame: baseline ] [ Designated as safety issue: No ]
    interview of family members, friends, relatives


Estimated Enrollment: 64
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Alaska Native women and their confidants

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02018640

Contacts
Contact: Christi A Patten, PhD 507-538-7370 patten.christi@mayo.edu

Locations
United States, Alaska
Alaska Native Tribal Health Consortium Recruiting
Anchorage, Alaska, United States, 99577
Contact: Timothy Thomas, MD    907-729-3095    tthomas@anthc.org   
Principal Investigator: Timothy Thomas, MD         
Sponsors and Collaborators
Mayo Clinic
Alaska Native Tribal Health Consortium
University of California, San Francisco
University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

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
Study First Received: December 17, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
cancer
tobacco use
pregnancy

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014