Biomarker Feedback to Motivate Cessation in Pregnancy
Condition: Nicotine Dependence; Pregnancy
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 3 Pilot Clinical Trial.
    

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 the investigators' successful partnership with the Alaska Native community and previous
      work with Alaska Native pregnant women. The investigators 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 the investigators 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, the investigators 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 60 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 the investigators' 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.

      This is the third and final phase of the project.
    

Intervention name(s): Biomarker feedback (phone based smoking cessation counseling); Control condition (phone based smoking cessation counseling)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling; phone-based behavioral smoking cessation counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment