Biomarker Feedback to Motivate Cessation in Pregnancy

NCT ID: NCT02431611

Last Updated: 2017-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

Brief 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.

Conditions

Nicotine Dependence; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control condition

Control behavioral phone-based smoking cessation intervention

Group Type: ACTIVE_COMPARATOR

Control condition (phone based smoking cessation counseling)

Intervention Type: BEHAVIORAL

phone-based behavioral smoking cessation counseling

Biomarker Feedback Intervention

Biomarker feedback plus behavioral phone-based smoking cessation intervention

Group Type: EXPERIMENTAL

Biomarker feedback (phone based smoking cessation counseling)

Intervention Type: BEHAVIORAL

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

Interventions

Biomarker feedback (phone based smoking cessation counseling)

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

Intervention Type: BEHAVIORAL

Control condition (phone based smoking cessation counseling)

phone-based behavioral smoking cessation counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Alaska Native Tribal Health Consortium

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Christi Patten

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christi A Patten, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Alaska Native Tribal Health Consortium

Anchorage, Alaska, United States

Countries

United States

Other Identifiers

11-001144-02

Identifier Type: -

Identifier Source: org_study_id