Clinical trial NCT02018640: Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2
Official title: Biomarker Feedback to Motivate Tobacco Cessation in Pregnant ALaska Native Women: Phase 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Tobacco Use
Pregnancy
Keywords: cancer
tobacco use
pregnancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Alaska Native Tribal Health Consortium
name: University of California, San Francisco
name: University of Minnesota
name: National Cancer Institute (NCI)
First posted: 2013-12-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alaska Native women and their confidants

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.

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 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

Primary outcomes:
measure: receptivity to cancer risk messages
timeFrame: baseline
Secondary outcomes:
measure: confidant perceptions of cancer risk information
timeFrame: baseline
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Native Tribal Health Consortium
state: Alaska
Study officials:
References: