Biomarker Feedback to Motivate Cessation in Pregnancy (MAW Phase 3)

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

Phase 3 Pilot Clinical Trial.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Nicotine Dependence
• Intervention / Treatment: Behavioral: Control condition (phone based smoking cessation counseling); Behavioral: Biomarker feedback (phone based smoking cessation counseling)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99577
      • Alaska Native Tribal Health Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control condition; Control behavioral phone-based smoking cessation intervention	Behavioral: Control condition (phone based smoking cessation counseling); phone-based behavioral smoking cessation counseling
Experimental: Biomarker Feedback Intervention; Biomarker feedback plus behavioral phone-based smoking cessation intervention	Behavioral: Biomarker feedback (phone based smoking cessation counseling); Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)	self-reported abstinence verified with cotinine	at week 36 gestation or greater up to the time of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy (Self-reported confidence scale)	Self-reported confidence scale	at week 36 gestation or greater up to the time of delivery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: University of California, San Francisco; University of Minnesota; Alaska Native Tribal Health Consortium
• Investigators: Principal Investigator: Christi A Patten, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 1, 2015

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 11-001144-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO