Trial document




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  DRKS00010089

Trial Description

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Title

"Healthy Eating, Active Play - Promoting a healthy lifestyle in Young CHILDren (HEALTH SURVEY)" – Study for the investigation of efficacy and cost effectiveness of the prevention program "Join the healthy boat - kindergarten"

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Trial Acronym

HEALTH SURVEY

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URL of the Trial

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

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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 kindergartners and 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 obesity: 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.
Kindergarten is a powerful setting for long-term and comprehensive measures: at low cost and with hardly any resources, many children can easily be reached. The study "Join the healthy boat - kindergarten" is a project promoting a healthy lifestyle in kindergartners. The study is designed for a one year intervention in the setting kindergarten 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 kindergarten year 2016/2017.
The group which received the intervention for one year is compared with a control group without intervention.

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Brief Summary in Scientific Language

"Join the healthy boat - kindergarten" is a health program to prevent overweight in Germany. It is a program in the setting kindergarten which aims at the development of a healthy lifestyle of kindergartners, offering alternatives for their diet, exercise behavior and leisure-time activities delivered by the child care workers. The program is carried out in the course of a kindergarten year supported by especially developed pre-structured lessons to be integrated into the daily routine as well as the involvement of parents. The program’s goal is the increase of physical activity of kindergartners, the reduction of consumption of sweetened drinks as well as the reduction of time spent in front of computers and TVs. The statewide spread of the program is realized by project delivery consultants: for each of the 44 districts of Baden-Württemberg child care workers are trained by the university staff who then continue to organize further training courses for child care workers in their region.
In the course of this program, efficacy and cost effectiveness of the intervention is examined in a randomized two-arm longitudinal fashion (HEALTH SURVEY). This means that the group which received the intervention for one year is compared with a control group without intervention. The randomization occurs by kindergartens. Furthermore, measurements are taken at two points: September/October 2016 (Baseline measurements); September/October 2017 (Follow-Up measurements). Hereby, the so called waiting control group design is used which means that in one group of kindergartens the program is carried out during the kindergarten year 2016/2017 (intervention group) whereas the other group of kindergartens do not receive any intervention, yet (control group). In the latter kindergartens the program is implemented after a waiting period of one year in the kindergarten year 2017/2018.

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Organizational Data

  •   DRKS00010089
  •   2016/02/24
  •   [---]*
  •   yes
  •   Approved
  •   188/15, 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 intervention program focusing on health promotion

    Program in the setting kindergarten which aims at the development of a healthy lifestyle of kindergartners, offering alternatives for their diet, exercise behavior and leisure-time activities delivered by the child care workers. The program is carried out in the course of a kindergarten year supported by especially developed pre-structured lessons to be integrated into the daily routine as well as the involvement of parents. The program’s goal is the increase of physical activity of kindergartners, the reduction of consumption of sweetened drinks as well as the reduction of time spent in front of computers and TVs.
  •   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 changes (difference of follow-up measurements and baseline
measurements) in
- nutrition (e.g. consumption of sugar-sweetened beverages, fruit, vegetables, high-calorie food)
- child’s time spent with screen media
- child’s physical activity/energy expenditure
- Health knowledge and attitude in parents and child care workers

The questionnaires are self-constructed.
Baseline measurements: September/October 2016
Follow-Up measurements: September/October 2017

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Secondary Outcome

Secondary outcomes are the changes (difference of follow-up measurements and baseline measurements) in
- anthropometric parameters (waist circumference, Waist-to-Height ratio, BMI, subcutaneous fat)
- child’s quality of life (EQ5D-Y Proxy Version, KINDL parent’s version)
- child: days sick leave, doctor’s consultation, hospitalization; parents: absence from work because of children’s sick
- child’s motor skills in sports
- environment of the kindergarten
- laboratory parameters (saliva, cheek swab): metabolic and inflammatory parameters, e.g. IL-6, TNF_, leptin, epigenetic investigation

The questionnaires are self-constructed. Child’s quality of life: EQ5D-Y Proxy Version and KINDL parent’s version

Baseline measurements: September/October 2016
Follow-Up measurements: September/October 2017

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2016/09/12
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   6   Years
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Additional Inclusion Criteria

-Intervention group: Child care worker has attend the program "Join the healthy boat - kindergarten" in the kindergarten year 2015/2016 or has to be enrolled for the participation in the program in the kindergarten year 2016/2017.
-Control group: Child care worker has to be enrolled for the participation in the program in the kindergarten 2016/2017.
- Informed consent of the kindergarten heads and child care workers who take part has to be submitted.
- Informed consent of the parents of the children who take part has to be submitted. Separate consent for each: measurement of physical activity, saliva, cheek swab

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Exclusion Criteria

- On part of the kindergartens no possibilities to collect the necessary data are given

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Addresses

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    • Sektion Sport- und Rehabilitationsmedizin, Universitätsklinikum Ulm
    • Mr.  Prof. Dr. med. Dr. h.c.  Jürgen M.  Steinacker 
    • Leimgrubenweg 14
    • 89075  Ulm
    • Germany
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    • Universitätsklinikum Ulm Sektion Sport- und Rehabilitationsmedizin Projektgruppe 'Komm mit in das gesunde Boot'
    • 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'
    • 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
    • Kriegsbergstraße 42
    • 70174  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/11/30
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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.