Clinical trial NCT01605643: Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women
Official title: Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women: Phase 1
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: 2012-05-25
Enrollment: 150
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women will be recruited through prenatal care

Brief summary: 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.

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 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.

Primary outcomes:
measure: NNAL
timeFrame: delivery
Secondary outcomes:
measure: cotinine
timeFrame: participants will be followed during pregnancy until approximately week 40 gestation and Infants will be assessed at birth only
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Native Tribal Health Consortium
state: Alaska
Study officials:
affiliation: Mayo Clinic
name: Christi A Patten, PhD
role: PRINCIPAL_INVESTIGATOR
References: