NCT01605643

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

5.3 years

First QC Date

May 7, 2012

Last Update Submit

December 15, 2017

Conditions

CancerTobacco UsePregnancy

Keywords

cancertobacco usepregnancy

Outcome Measures

Primary Outcomes (1)

  • NNAL

    delivery

Secondary Outcomes (1)

  • cotinine

    participants will be followed during pregnancy until approximately week 40 gestation and Infants will be assessed at birth only

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women will be recruited through prenatal care

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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Native Tribal Health Consortium

Anchorage, Alaska, 99577, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine and serum specimen samples collected from mother and infant pairs

MeSH Terms

Conditions

NeoplasmsTobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christi A Patten, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 25, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Locations

US(1)