NCT00435344

Brief Summary

The purpose of this study was to determine whether a pediatric practice-based smoking prevention and cessation intervention increases abstinence rates among adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,711

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 1999

Longer than P75 for phase_2

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

February 1, 1999

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
Last Updated

February 14, 2007

Status Verified

February 1, 2007

First QC Date

February 12, 2007

Last Update Submit

February 12, 2007

Conditions

Keywords

Pediatric practiceSmoking cessationSmoking preventionAdolescents

Outcome Measures

Primary Outcomes (1)

  • Abstinence from smoking in the past 30 days at 6 months and 1 year

Interventions

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 13 to 17, regardless of smoking status
  • Scheduled for routine or acute care office visit
  • Parental consent and youth assent

You may not qualify if:

  • Unable to complete study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • Pbert L, Flint AJ, Fletcher KE, Young MH, Druker S, DiFranza JR. Effect of a pediatric practice-based smoking prevention and cessation intervention for adolescents: a randomized, controlled trial. Pediatrics. 2008 Apr;121(4):e738-47. doi: 10.1542/peds.2007-1029.

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Study Officials

  • Lori Pbert, Ph.D.

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 14, 2007

Study Start

February 1, 1999

Study Completion

January 1, 2004

Last Updated

February 14, 2007

Record last verified: 2007-02

Locations