NCT02697409

Brief Summary

A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups.

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
20,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 5, 2017

Status Verified

May 1, 2016

Enrollment Period

3.3 years

First QC Date

February 27, 2016

Last Update Submit

June 2, 2017

Conditions

TobaccoPreventionAdolescentsSchools

Outcome Measures

Primary Outcomes (1)

  • Smoking prevalence measured via questionnaire.

    The difference in smoking prevalence at 24 months follow-up is the primary endpoint measured via questionnaires.

    24 months post baseline

Secondary Outcomes (2)

  • Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.

    24 months follow-up

  • Changes in smoking behavior

    24 months post baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group receives two school-based modules taking less than two hours each delivered by medical students in the schools.

Behavioral: Education Against Tobacco intervention

Control group

NO INTERVENTION

Interventions

Education Against Tobacco interventionBEHAVIORAL
Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pupils of 7th grade of regular secondary schools in Germany

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Titus Brinker

Bünde, 32257, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cand. med.

Study Record Dates

First Submitted

February 27, 2016

First Posted

March 3, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

June 5, 2017

Record last verified: 2016-05

Locations

DE(1)