Trial document



drksid header

  DRKS00000494

Trial Description

start of 1:1-Block title

Title

Join the Healthy Boat - Primary School

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.gesundes-boot.de/grundschule

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

High prevalence of overweight in childhood has become a major problem in most industrialized countries. In Germany more and more of the primary school children are already overweight. The causes for overweight and obesity are multimodal. Not only genetic predisposition but also lifestyle factors can be held responsible for the increasing prevalence of overweight and adiposity: little physical activity and an excessive intake of calories. There are various negative environmental conditions which could influence childhood development negatively. Overweight children and adolescents run a higher risk of being overweight as adults in comparison to their normal-weight contemporaries, which is why they suffer more often from obesity associated diseases like diabetes mellitus than normal-weight children. The fact that both the impairments on health as well as the psychosocial impact which are closely linked to overweight and the difficulties of mostly insufficient therapeutic measures show the urgent need of prevention.
School is a powerful setting for long-term and comprehensive measures: At low cost and with hardly any resources, all children can easily be reached.
The study "Komm mit in das gesunde Boot - Grundschule" is a project promoting a healthy lifestyle in primary school children. The study is designed for a one year school-based intervention with the main topics of promoting physical activity, reducing the consumption of sweetened drinks and reducing the time spent in front of computer and television screens. For this, special pre-instructed lessons have been developed. The effects of this intervention will be examined in the school year 2010/2011.
The project is based on the positive experience of the pilot study URMEL-ICE ("Ulm Research on Metabolism, Exercise, and Lifestyle-Intervention in Children") which has been carried out in 64 classes of the region Ulm (Germany) since 2006.
This project is a randomised controlled study, which aims to examine the effectiveness of a program which aims at the prevention of overweight in childhood. URMEL-ICE showed a positive development primarily on the pupil’s stature, fitness and health-related quality of life.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

"Join the Healthy Boat - Primary School" is an intervention to prevent overweight in Germany. The programme is a school-based programme which aims at the development of a healthy lifestyle of primary school children, offering action alternatives for their diet, physical activity behaviour and leisure-time activities delivered by the regular teacher. This is carried out in the course of a school year supported by especially developed pre-structured lessons to be integrated into the day-to-day curriculum as well as the involvement of parents. The programme’s goal is the increase of physical activity of primary school children, the reduction of consumption of sweetened drinks as well as the reduction of time spent in front of computers and telvisions. The statewide spread of the programme is realised by a so called train the trainer system: For each of the 44 districts of Baden-Württemberg teachers are trained by the university's staff who then continue to organise further training courses for teachers in their region.
In the course of this programme the effectiveness of the intervention is examined in a randomised two-arm longitudinal fashion (evaluation study - Baden-Württemberg Study). This means that the group which received the intervention for one year is compared with a control group without intervention. The randomisation was carried out on school level, not class level. Furthermore, measurements are taken at two points: The first lot is taken at the beginning of the school year 2010/2011, the second lot at the beginning of the school year 2011/2012. Hereby, the so called waiting control group design is used which means that in one group of schools the programme is carried out during the school year 2010/2011 (intervention group) whereas the other group of schools do not receive any intervention, yet (control group). In the latter schools the programme is implemented after a waiting period of one year in the school year 2011/2012. Only first and second grades are involved in this evaluation study.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000494
  •   2010/08/25
  •   [---]*
  •   yes
  •   Approved
  •   126/10, Ethik-Kommission der Universität Ulm
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E66.9 -  Obesity, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention group: One year school-based intervention program focusing on health promotion
  •   Control group: No intervention
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcomes are the reduction of increases of age related growth in the anthropometric parameters like subscapular skin fold thickness, abdominal circumference and the covered distance in a six-minute-run as difference between the follow-up measurements and baseline measurements.
For this purpose, trained teams will test not only the children’s motor skills but also carry out physical examinations within a regular school day at two points in time.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcomes are the changes (difference of follow-up measurements and baseline measurements) in the following parameters:
- anthropometric parameters (e.g. BMI)
- child’s quality of life
- child’s motor skills in sports
- child’s cognitive achievements
- child’s nutrition
- child’s physical activity
- child’s time spent with screen media
- environment of the school
With questionnaires not only teachers and parents but also children are polled at the two testing points.
Measurements regarding cognitive skills as well as physical examination and motor skills in sports are taken by trained teams during regular school time.
The use of accelerometers is planned in order to examine the children’s physical activity.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/09/20
  •   1943
  •   [---]*
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   8   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Teacher has to be enrolled for the participation in the program in the school year 2010/2011
- Informed consent of the school heads and teachers who take part has to be submitted
- Informed consent of the parents of the children who take part has to be submitted

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- On part of the schools no possibilities to collect the necessary data are given
- A too low number of parents give their informed consent to collect their child’s data

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Ulm Sektion Sport- und Rehabilitationsmedizin
    • Mr.  Prof. Dr. med. Dr. h.c.  Jürgen Michael  Steinacker 
    • Leimgrubenweg 14
    • 89070  Ulm
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Ulm Sektion Sport- und Rehabilitationsmedizin Projektgruppe 'Komm mit in das gesunde Boot - Grundschule'
    • Ms.  Dr.  Susanne  Kobel 
    • Frauensteige 6
    • 89075  Ulm
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Ulm Sektion Sport- und Rehabilitationsmedizin Projektgruppe 'Komm mit in das gesunde Boot - Grundschule'
    • Ms.  Ileana  Briegel 
    • Frauensteige 6
    • 89075  Ulm
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Baden-Württemberg Stiftung gGmbH
    • Kriegsbergstr. 42
    • 70174  Stuttgart
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2011/11/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.