NCT01145729

Brief Summary

  1. 1.To do formative work with healthcare providers, clinic staff and parents to develop a protocol for a clinic system to routinely collect blood from children at risk of SHS exposure conduct laboratory testing for tobacco toxicants, document exposure in the electronic medical record (EMR) and incorporate the biomarker feedback into a parental smoking treatment plan.
  2. 2.To pilot test effects of a clinic system to screen children at risk of SHS exposure with laboratory testing for tobacco toxicants on provider delivery of tobacco treatment services (primary outcome).
  3. 3.To pilot test effects of a clinic system to screen children at risk of SHS exposure with laboratory testing for tobacco toxicants on parent smoking behavior (participation in smoking cessation treatment, smoking cessation and implementation of smoking restrictions).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 17, 2010

Status Verified

March 1, 2010

Enrollment Period

6 months

First QC Date

June 16, 2010

Last Update Submit

June 16, 2010

Conditions

Biomarker FeedbackSmoking CessationSecondhand Smoke ExposureProvider Behavior

Keywords

Biomarker feedbackSmoking cessationChildhood secondhand smoke exposure

Outcome Measures

Primary Outcomes (1)

  • Provider Delivery of Tobacco Treatment Services

    Whether or not biomarker feedback testing of secondhand smoke will prompt providers to deliver tobacco treatment services

    12 weeks

Secondary Outcomes (1)

  • Parent Smoking Behavior

    12 weeks

Study Arms (2)

Biomarker feedback

ACTIVE COMPARATOR

Biomarkers of tobacco exposure (laboratory values) delivered to health care provider

Behavioral: Biomarker Feedback

Usual care (general counseling)

PLACEBO COMPARATOR

Brochure about pesticides, lead, SHS

Behavioral: Biomarker Feedback

Interventions

Biomarker FeedbackBEHAVIORAL

Providing providers biomarker feedback on childhood secondhand smoke exposure

Biomarker feedbackUsual care (general counseling)

Eligibility Criteria

Age12 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • M or 24M well-visit
  • Scheduled to a lead test
  • Current smoker

You may not qualify if:

  • Cannot speak English
  • No phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Department of Medicine

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 17, 2010

Record last verified: 2010-03

Locations

US(1)