Trial document



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  DRKS00000494

Trial Description

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Title

Join the Healthy Boat - Primary School

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Trial Acronym

[---]*

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URL of the Trial

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

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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.

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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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000494
  •   2010/08/25
  •   [---]*
  •   yes
  •   Approved
  •   126/10, Ethik-Kommission der Universität Ulm
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66.9 -  Obesity, unspecified
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Interventions/Observational Groups

  •   Intervention group: One year school-based intervention program focusing on health promotion
  •   Control group: No intervention
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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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.

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2010/09/20
  •   1943
  •   [---]*
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   8   Years
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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

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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

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Addresses

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    • Universitätsklinikum Ulm Sektion Sport- und Rehabilitationsmedizin
    • Mr.  Prof. Dr. med. Dr. h.c.  Jürgen Michael  Steinacker 
    • Leimgrubenweg 14
    • 89070  Ulm
    • Germany
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    • Universitätsklinikum Ulm Sektion Sport- und Rehabilitationsmedizin Projektgruppe 'Komm mit in das gesunde Boot - Grundschule'
    • Ms.  Dr.  Susanne  Kobel 
    • Frauensteige 6
    • 89075  Ulm
    • Germany
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    • Universitätsklinikum Ulm Sektion Sport- und Rehabilitationsmedizin Projektgruppe 'Komm mit in das gesunde Boot - Grundschule'
    • Ms.  Ileana  Briegel 
    • Frauensteige 6
    • 89075  Ulm
    • Germany
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Sources of Monetary or Material Support

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    • Baden-Württemberg Stiftung gGmbH
    • Kriegsbergstr. 42
    • 70174  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/11/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.