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Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW)

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:
NCT01605643
First received: May 7, 2012
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

Use of tobacco is very high among Alaska Native women. The investigators are conducting a three phase study. The first phase will examine biomarkers of tobacco exposure in pregnant women and their newborns. The second phase is a qualitative study to translate the biomarker findings into intervention messages. The third phase is a pilot of the biomarker feedback intervention compared with a control condition.


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 1

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • NNAL [ Time Frame: delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cotinine [ Time Frame: participants will be followed during pregnancy until approximately week 40 gestation and Infants will be assessed at birth only ] [ Designated as safety issue: No ]
    tobacco exposure measured during pregnancy and at delivery


Biospecimen Retention:   Samples With DNA

urine and serum specimen samples collected from mother and infant pairs


Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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 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, we 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 80 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

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women will be recruited through prenatal care

Criteria

Inclusion Criteria:

To be eligible the woman must:

  1. be Alaska Native,
  2. be aged 18 years or older,
  3. provide written informed consent,
  4. be currently pregnant (1st, 2nd or 3rd trimester), and
  5. plan to deliver at the ANMC. An additional inclusion criterion for current tobacco users is any use in the past 7 days. Our preliminary studies indicate that women may use more than one form of tobacco. To enhance feasibility of recruitment and generalizability, women will not be excluded if they use more than one form of tobacco. Instead, group composition will be based on the primary type of tobacco used. An additional inclusion criterion for non-tobacco users is no use of any form of tobacco in the last 6 months.

Exclusion Criteria:

  1. Women will be excluded if they have used nicotine replacement therapy (NRT) or have participated in a behavioral or pharmacological tobacco cessation program within the past 30 days.
  2. Alcohol and other drug use will not be an exclusionary criterion because the biomarkers are specific to tobacco exposure.
  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: NCT01605643

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
Investigators
Principal Investigator: Christi A Patten, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Christi Patten, Professor of Psychology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01605643     History of Changes
Other Study ID Numbers: 11-001144, U54CA153605
Study First Received: May 7, 2012
Last Updated: June 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
cancer
tobacco use
pregnancy

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

ClinicalTrials.gov processed this record on October 22, 2014