NCT01306552

Brief Summary

The purpose of this study is to evaluate the effectiveness of a combined parent-student program for smoking prevention in 7th graders in Berlin schools.

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
3,400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration 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

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 2, 2011

Status Verified

January 1, 2011

Enrollment Period

2.8 years

First QC Date

March 1, 2011

Last Update Submit

March 1, 2011

Conditions

Keywords

Tobacco useAdolescentsPrimary preventionProgram effectivenessParental component

Outcome Measures

Primary Outcomes (1)

  • Percentage of regular smokers among students at the 2 year follow-up assessment.

    The primary study outcome is the percentage of regular smokers among students at the 2 year follow-up assessment.

    2 years

Secondary Outcomes (1)

  • Students' attitudes towards smoking and smoking-related self-efficacy

    2 years

Study Arms (3)

Student-intervention only group

ACTIVE COMPARATOR

Schools randomized to intervention only (arm 1) will agree to visit the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?"). One school class of students will visit the parcours once during a school day. The parcours takes approximately 3 hours to complete. The parcours consists of 7 interactive stations where a class of students learns about differences between smokers and non-smokers in terms of health status such as atherosclerosis prevalence, loss of smell or lung capacity and aging. Students also learn about the toxic ingredients in cigarettes. Each station includes a quiz to complete by each group of students. At the end of the parcours, a moderator will announce which group of students accumulated the most points. For more information on the contents of the parcours see http://www.karuna-prevents.de/index.php.

Behavioral: Student-Intervention only group

Multi-component intervention

ACTIVE COMPARATOR

Schools randomized to the student-parent intervention arm also will agree to visit the KARUNA e.V. smoking prevention parcours. In addition, the schools will agree to have one parents' night presented by trained health coaches informing parents about smoking prevention topics in youth during the school year. Trained health coaches will give an evaluated smoking prevention presentation for parents at the parents' nights at the end of the first school year. Also, participating parents will receive information about successful ways to prevent smoking and promote smoking cessation in their children once by mail.

Behavioral: Multi-component Intervention

Control Group

ACTIVE COMPARATOR

Schools randomized to the control school will be offered to participate in the nutrition and exercise prevention program offered by KARUNA e.V. during the 2-year study.

Behavioral: Control Group

Interventions

One visit to the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?") during 7th grade. The parcours takes approximately 3 hours to complete. The parcours consists of 7 interactive stations where a class of students learns about differences between smokers and non-smokers in terms of health status such as atherosclerosis prevalence, loss of smell or lung capacity and aging. Students also learn about the toxic ingredients in cigarettes. Each station includes a quiz to complete by each group of students. At the end of the parcours, a moderator will announce which group of students accumulated the most points. For more information on the contents of the parcours see http://www.karuna-prevents.de/index.php.

Student-intervention only group

One visit to the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?") + one parent night with information about smoking prevention and one informational letter by mail

Multi-component intervention
Control GroupBEHAVIORAL

One visit to the Nutrition and Physical Activity Parcours offered by KARUNA e.V. ("Kinderleicht gesund zu leben"). (same set up as the smoking prevention parcours with topics around healthy nutrition and promotion of physical activity)

Control Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • it is located in Berlin
  • has 7th grade classes (students between 12-15 years)

You may not qualify if:

  • schools offers an extensive smoking prevention program for their students that includes parental involvement.
  • schools that do not agree to stop visiting the KARUNA e.V. smoking parcours (if they do) for the next two years in case of being randomized to the control group.
  • schools that do not agree to have a parents' night (separate or part of the typical parents' nights) where trained health coaches will introduce and discuss the topic of smoking prevention in youth in case of being randomized to the combined student-parent intervention.
  • Female or male in the 7th grade
  • Signed written assent
  • Intellectual and physical ability of participant to make an informed decision about study participation
  • Attends one of the participating schools
  • Has signed approval from parent/caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics

Berlin, 10117, Germany

RECRUITING

Related Publications (2)

  • Krist L, Lotz F, Burger C, Strobele-Benschop N, Roll S, Rieckmann N, Muller-Nordhorn J, Willich SN, Muller-Riemenschneider F. Long-term effectiveness of a combined student-parent and a student-only smoking prevention intervention among 7th grade school children in Berlin, Germany. Addiction. 2016 Dec;111(12):2219-2229. doi: 10.1111/add.13537. Epub 2016 Sep 19.

  • Muller-Riemenschneider F, Krist L, Burger C, Strobele-Benschop N, Roll S, Rieckmann N, Muller-Nordhorn J, Willich SN. Berlin evaluates school tobacco prevention - BEST prevention: study design and methodology. BMC Public Health. 2014 Aug 23;14:871. doi: 10.1186/1471-2458-14-871.

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Stefan N Willich, MD

    Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

October 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 2, 2011

Record last verified: 2011-01

Locations