Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women

Completed

Conditions studied: Cancer, Tobacco Use, Pregnancy

In brief

Use of tobacco is very high among Alaska Native women. The investigators are conducting a three phase study. The first phase will examine biomarkers of tobacco exposure in pregnant women and their newborns. The second phase is a qualitative study to translate the biomarker findings into intervention messages. The third phase is a pilot of the biomarker feedback intervention compared with a control condition.

Key facts

Study ID

NCT01605643

Run by

Mayo Clinic

People needed

150

Starts

2012-03-01

Expected to finish

2017-12-01

Last updated by the study team

2017-12-19

Who can join

Age: any, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible the woman must:
• be Alaska Native,
• be aged 18 years or older,
• provide written informed consent,
• be currently pregnant (1st, 2nd or 3rd trimester), and
• plan to deliver at the ANMC. An additional inclusion criterion for current tobacco users is any use in the past 7 days. Our preliminary studies indicate that women may use more than one form of tobacco. To enhance feasibility of recruitment and generalizability, women will not be excluded if they use more than one form of tobacco. Instead, group composition will be based on the primary type of tobacco used. An additional inclusion criterion for non-tobacco users is no use of any form of tobacco in the last 6 months.

You may not qualify if…

• Women will be excluded if they have used nicotine replacement therapy (NRT) or have participated in a behavioral or pharmacological tobacco cessation program within the past 30 days.
• Alcohol and other drug use will not be an exclusionary criterion because the biomarkers are specific to tobacco exposure.

Where it is running

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

Full record on ClinicalTrials.gov

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