Condition category
Not Applicable
Date applied
24/09/2013
Date assigned
04/10/2013
Last edited
26/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Physical activity during childhood and adolescence is associated with substantial health benefits. However, only 22.7% of German adolescents are sufficiently physically active. Thus, the promotion of an active lifestyle in youth is an important aspect of public health. This study will evaluate the feasibility and effectiveness of the program in 8th grade students in Germany (Federal State of Schleswig-Holstein).

Who can participate?
Students of public schools between 13 and 15 years of age.

What does the study involve?
The Institute for Therapy and Health Research in cooperation with the Universities of Hamburg and Kiel developed the 'läuft.' program to improve physical activity in schoolchildren. Schools were randomly allocated to either the control group (treatment as usual) or the intervention group (lauft program). 'läuft.' is a school-based program that targets different levels: students, classes, schools and parents. The main components are two class competitions. On the one hand, each student receives a pedometer and documents his/her steps using an interactive user account on the 'läuft.' homepage. Classes achieving the highest step totals will be awarded. On the other hand, classes will be invited to implement and document physical activity-related school projects. The most creative and inventive ideas will also be awarded. Additionally, classes take part in educational lessons. Parents will receive information material about the benefits of physical activity and how they can support their children to engage in a physically active lifestyle. The headmaster and teaching staff of the participating schools will get information material with suggestions and encouragement to enhance physical activity in school. Information about students' physical activity-related attitudes and behavior will be assessed by questionnaires. In addition, physical fitness and parameters such as weight, height and blood pressure will be determined.

What are the possible benefits and risks of participating?
Participating schools will be provided with intervention material (pedometers, information material and teaching material) and will receive incentives for their effort.

Where is the study run from?
About 100 secondary schools in the Federal State of Schleswig-Holstein in Germany.

When is the study starting and how long is it expected to run for?
The study will start in November 2013 and will run until July 2015. In November and December 2013 the recruitment of participants will be conducted. Assessments will be carried out by trained research staff at three times: before the start of the program (January/February 2014), immediately after the program (June/July 2014), and one year after the program (June/July 2015).

Who is funding the study?
German Cancer Aid

Who is the main contact?
Prof. Reiner Hanewinkel
hanewinkel@ift-nord.de

Trial website

http://www.laeuft.info

Contact information

Type

Scientific

Primary contact

Prof Reiner Hanewinkel

ORCID ID

Contact details

IFT-Nord Institute for Therapy and Health Research
Harmsstr. 2
Kiel
24114
Germany
-
hanewinkel@ift-nord.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The 'läuft.' trial - a cluster randomized-controlled study of a school-based multi-component program to establish a physically active lifestyle in adolescence

Acronym

Study hypothesis

'läuft.' shows an effect on physical-activity related attitudes and behavior, sedentary behavior and cardiovascular risk factors (Body Mass Index, blood pressure, body composition and cardiovascular fitness).

Ethics approval

1. The ethics committee of the German Psychological Society (DGPs), 18/10/2012
2. The Ministry of Education and Science of Schleswig-Holstein, 10/07/2013

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Establishing a physical active lifestyle and improve health and fitness in youth

Intervention

Intervention schools: implementation of the 'läuft.' program
Control schools: treatment as usual
Data collection in 3 waves
Unit of allocation: schools

Intervention: The 'läuft.' targets four different levels:
1. Each student receives a pedometer and documents his/her steps over 12 weeks using an interactive user account on the 'läuft.' homepage.
2. On class level there will be different competitions. The classes that achieve the most steps in selected weeks, the highest increases of steps and that develop the most inventive ideas to promote physical activity in school will be awarded. Besides, the intervention includes four educational lessons.
3. The headmaster and teaching staff of the participating schools will get information material with suggestions and encouragement to enhance physical activity in school. Participating teachers will be invited to an introductory seminar.
4. Parents will be involved with informational material about the program and will be invited to a parent-teacher conference about benefits of being physical active and how they can support their children to engage in a physical active lifestyle.

The intervention duration is 12 weeks. Before, immediately after and one year after the intervention assessments will be conducted in both groups.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Lifestyle behavior concerning physical activity and sedentary behavior, physical activity-related psychological and social constructs as well as cardiovascular fitness, Body Mass Index, blood pressure, body composition (fat mass) and waist circumference before, at the end and 12 months after the intervention.

Secondary outcome measures

Given impulses with regard to physical activity and activating strategies will be assessed qualitatively at the end of the intervention.

Overall trial start date

01/11/2013

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Students of public schools
2. Aged between 13 and 15 (8th grade), either sex

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

46 classes / 911 students

Participant exclusion criteria

1. Schools for disabled students
2. Missing parental consent

Recruitment start date

01/11/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Germany

Trial participating centre

IFT-Nord Institute for Therapy and Health Research
Kiel
24114
Germany

Sponsor information

Organisation

German Cancer Aid (Germany)

Sponsor details

Buschstr. 32
Bonn
53115
Germany
-
deutsche@krebshilfe.de

Sponsor type

Charity

Website

http://www.krebshilfe.de

Funders

Funder type

Charity

Funder name

German Cancer Aid (Germany) (ref: 110012)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24304715
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26494609

Publication citations

  1. Protocol

    Suchert V, Isensee B, Hansen J, Johannsen M, Krieger C, Müller K, Sauer I, Weisser B, Sargent JD, Hanewinkel R, "läuft."--a school-based multi-component program to establish a physically active lifestyle in adolescence: study protocol for a cluster-randomized controlled trial., Trials, 2013, 14, 416, doi: 10.1186/1745-6215-14-416.

  2. Results

    Suchert V, Isensee B, Sargent J, Weisser B, Hanewinkel R; läuft. Study Group, Prospective effects of pedometer use and class competitions on physical activity in youth: a cluster-randomized controlled trial, Prev Med, doi: 10.1016/j.ypmed.2015.10.002.

Additional files

Editorial Notes