Biomarker Feedback to Motivate Cessation in Pregnancy

Study Overview
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Brief Summary
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Phase 3 Pilot Clinical Trial.

Detailed Description
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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.

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

Conditions
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Pregnancy, Nicotine Dependence

Intervention / Treatment
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* Behavioral: Biomarker feedback (phone based smoking cessation counseling)
* Behavioral: Control condition (phone based smoking cessation counseling)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |