NCT00726141

Brief Summary

Despite rising smoker rates, particularly in girls and young women, only few studies have focused on smoking cessation in young smokers. Gynaecologist practices may be an ideal setting to proactively intervene with young female smokers. Elevated health risks of smoking while using hormonal contraceptives could be a successful approach to gain young women's attention on smoking cessation. The purpose of this study is to evaluate the effectiveness of a smoking cessation intervention for girls and young women visiting gynaecologist practices and using hormonal contraceptives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
699

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

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

October 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
Last Updated

July 31, 2008

Status Verified

July 1, 2008

Enrollment Period

3 months

First QC Date

July 28, 2008

Last Update Submit

July 30, 2008

Conditions

Smoking

Keywords

Brief InterventionSmoking CessationMotivational InterviewingExpert SystemReadiness to ChangeHormonal ContraceptiveAdolescents

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    12 months

Secondary Outcomes (4)

  • Reduction of smoking

    12 months

  • Readiness to change variables

    12 months

  • Level of nicotine dependence

    12 months

  • Quit attempts

    12 months

Interventions

Brief intervention, Motivational Interviewing, Expert SystemBEHAVIORAL

Motivational Interviewing, stage-tailored self-help manual, physician letter, expert system feedback letter

Eligibility Criteria

Age14 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 14-25
  • Having smoked at least 1 cigarette within last 4 weeks
  • Use of hormonal contraceptives or intention for prescription within next 2 weeks

You may not qualify if:

  • Pregnancy
  • Emergency treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lübeck

Lübeck, Germany

Location

MeSH Terms

Conditions

SmokingSmoking Cessation

Interventions

Crisis InterventionMotivational Interviewing

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesDirective CounselingCounselingMental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • PD Dr. Hans-Jürgen Rumpf, Dipl.-Psych.

    University of Luebeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 31, 2008

Study Start

October 1, 2004

Primary Completion

January 1, 2005

Study Completion

October 1, 2007

Last Updated

July 31, 2008

Record last verified: 2008-07

Locations

DE(1)