Clinical trial · Observational
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women
Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women: Phase 1
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pregnancy | — | UNRESOLVED | — |
| Tobacco Use | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- NNAL
- timeFrame
- delivery
Secondary outcomes (1)
- measure
- cotinine
- timeFrame
- participants will be followed during pregnancy until approximately week 40 gestation and Infants will be assessed at birth only
- description
- tobacco exposure measured during pregnancy and at delivery
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: To be eligible the woman must: 1. be Alaska Native, 2. be aged 18 years or older, 3. provide written informed consent, 4. be currently pregnant (1st, 2nd or 3rd trimester), and 5. 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. Exclusion Criteria: 1. 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. 2. Alcohol and other drug use will not be an exclusionary criterion because the biomarkers are specific to tobacco exposure.
References
Publications (0)
Data not yet available