Skip to main content
OpenTrials
Completed

NCT Number: NCT02431611

Biomarker Feedback to Motivate Cessation in Pregnancy

Phase 3 Pilot Clinical Trial.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99577, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Alaska Native
  • 18 years or older
  • provide written informed consent
  • be currently pregnant and at <24 weeks gestation
  • reside in Anchorage and plan to deliver at the ANMC
  • current tobacco user defined as any use of Iqmik, commercial ST, and/or cigarettes during the past 7 days.

Exclusion criteria

  • use of using nicotine replacement therapy or medications for tobacco cessation or participation in a behavioral cessation program within the past 30 days
  • another woman from the same household has enrolled.

Treatment and study plan

Biomarker feedback (phone based smoking cessation counseling)

Behavioral

Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling

Control condition (phone based smoking cessation counseling)

Behavioral

phone-based behavioral smoking cessation counseling

Primary outcomes

  1. smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)

    Time frame: at week 36 gestation or greater up to the time of delivery

    self-reported abstinence verified with cotinine

Secondary outcomes

  1. Self-efficacy (Self-reported confidence scale)

    Time frame: at week 36 gestation or greater up to the time of delivery

    Self-reported confidence scale

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Alaska Native Tribal Health Consortium
  • University of California, San Francisco
  • University of Minnesota

Registry information

Official study title

Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW) - Phase 3 Pilot Clinical Trial

Acronym: MAW Phase 3

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 1, 2015
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.