Brief Interventions on Smoking for Hormonal Contraceptive Users

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

699 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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In the randomized controlled trial, female smokers aged 14-25 will be recruited in practices of gynaecologists. Intervention within the practice consists of a 30 minutes counseling session based on Motivational Interviewing, a standardised physician letter focusing on the elevated health risks of smoking while using hormonal contraceptives and a stage-matched self-help manual. After four weeks, an expert system feedback letter will be sent. In the intervention group, no smoking intervention will be given. Follow-up assessments will be conducted after 12 months, including saliva cotinine measures.

Conditions

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Smoking

Keywords

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Brief Intervention Smoking Cessation Motivational Interviewing Expert System Readiness to Change Hormonal Contraceptive Adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Brief intervention, Motivational Interviewing, Expert System

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pregnancy
* Emergency treatment

Minimum Eligible Age

14 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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University of Lübeck, Research group S:TEP (Substance misuse: Treatment, Epidemiology and Prevention)

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck

Locations

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University of Lübeck

Lübeck, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BMBF grant no: 01EB0421

Identifier Type: -

Identifier Source: secondary_id

01EB0421