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临床试验/NCT02018640
NCT02018640已完成不适用

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

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
39
试验地点
1
主要终点
receptivity to cancer risk messages

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be eligible the woman must:
  • be Alaska Native
  • be aged 18 years of age or older
  • provide written informed consent
  • have participated in Phase 1 of the research or is currently pregnant (<= 24 weeks gestation)
  • 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:
  • be referred by the woman participant
  • be aged 18 years of age or older
  • provide written informed consent

排除标准

  • does not provide written informed consent

结局指标

主要结局

receptivity to cancer risk messages

时间窗: baseline

interview of participant reactions to biomarker findings

次要结局

  • confidant perceptions of cancer risk information(baseline)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christi Patten

Professor of Psychology

Mayo Clinic

研究点 (1)

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