Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005275

Trial Description

start of 1:1-Block title

Title

Ballschule - leicht gemacht (Ball School - easy): Physical exercise and diet counselling for overweight children.

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

[---]*

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

Brief Summary in Lay Language

According to the results of the Robert-Bosch- study (2006), 15 % of children and youth are overweight in Germany. In order to control obesity it plays an important role to ensure sufficient physical activity and dietary change.
The aim of the project „Ballschule - leicht gemacht“ (Ball school – easy) was to find out about the influence of increased physical activity and nutrition counselling on different developmental features in overweight primary school children. Between 2006 and 2010 about 120 six to twelve year old primary school children participated in one of the four different programs over a six month period: The first group followed an exercise program, the second group a nutrition counselling, the third participated in both, the fourth group remained without a program. This controlled study design wants to investigate the diverse effects of the different therapy programs on overweight children.
Prior to the intervention and six months later the children were examined for their health status at the Centre for Children's and Youth Medicine in Heidelberg. In addition to this, the children took part in tests on motor skills, cognitive performance and psychosocial behavior.
After the primary examination the 1,5 hour exercise program was offered twice per week. Within the timeframe of the study, there were a total of eight units of the nutrition counselling, partially together with their parents. Within the program for promoting sports the key aspect of the exercise program was a ball sports class, led by the Ball School Program where they focused on teaching ball sport specific aspects. In order to support body awareness, psychosocial games were added to the lessons and the meaning of daily activities was explained. The nutrition counselling implemented a prevention program of the Research Institute for Pediatric Nutrition in Dortmund, the optimized mixed diet.
In terms of the expected results of this intervention, a weight reduction was supposed to correlate to a decrease in the thickness of the cervical artery. Also it was assumed, that children participating in both programs, would lose weight most efficiently and the groups participating in the exercise program would improve their motor skills more than children undergoing only the nutrition counselling or none of the therapy programs.

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

Brief Summary in Scientific Language

Recent studies show that the prevalence of overweight children is on the rise worldwide. Weight gain in children not only leads to changes in medical and health parameters, but also to limited motor skills, cognitive and psychosocial development. There are hardly any long term therapy programs which are evaluated for young children and adolescence. The interdisciplinary study of the Institute of Sports and Sports Sciences, the Centre for Children's and Youth Medicine as well as the Internal Medicine of the University of Heidelberg implemented the "Ballschule - leicht gemacht" (Ball school – easy) project to show the effects of increased exercise and nutrition counselling on the overall development of overweight and obese children.
160 primary school children participated in the study between 2006 and 2010. The children were randomized into four groups: Group A) did a Ball School program which was modified for the specific target group, group B) had a nutrition counselling together with their parents, group C) had both: ball sports and nutrition counselling, group D) was a control group without intervention. For analyzing the effects of the different therapy programs, the analysis of variance is applied as the study design. This allows proof of efficiency of the interventions compared to the control group as well as the effects of the different therapy programs. The study design contains a research plan with a dual repeated measurement factor and a fourfold space factor intervention.
The interventions took place during a six month study period. For monitoring their impact – equivalent to the interdisciplinary and holistic approach of the study - a spectrum of medical and nutritional science parameters (BMI, blood pressure, IMT, FMD, eating and drinking habits), features of motor control (endurance performance, total body coordination, fine and visuomotor skills, ball skills) as well as cognitive and psychosocial variables (concentration, self-concept, intelligence) was used.
There is an estimated correlation between weight reduction and improvement of the functional (FMD), morphologic (IMT) and biochemical (lipid profile, insulin resistance, hs-CRP) parameters. Increased physical activity and / or dietary change should also relate to an improved function of the endothelium.
The overall motor skills are expected to improve, e.g. the fine motor skills and general motor abilities, as well as psychosocial features such as the ability to concentrate or the self-concept. Sport specific abilities like ball coordination, technical and tactical skills are supposed to get better, too.
The connection between the medical -and sports scientific results is used for the scientific benefit. Therefore interdisciplinary correlation hypotheses become important, for instance: Will an increase in physical performance lead to an improved function of the endothelium? Which effects can be achieved by just combining the two parts of physical activity and nutrition counselling, but not by implementing only one of them?
During the procedure of the program they focused on mediating sport specific skills, which are supposed to enable the children to take part in regular club sports after completing the program. Focusing on improving their sport specific skills during the program shows that a greatest possible weight reduction was marginal. Having fun doing sports is the essential goal, because this is the only way to enhance their kinesic behavior. The nutrition counselling worked with the prevention concept the optimized mixed diet (OptimiX) of the Research Institute for Pediatric Nutrition in Dortmund.

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

Organizational Data

  •   DRKS00005275
  •   2014/03/06
  •   [---]*
  •   yes
  •   Approved
  •   213/2006, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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

  •   E66.09 -  [generalization E66.0: Obesity due to excess calories]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Arm 1: The movement therapy procedures are based on the concept of the Heidelberg ball school (Roth & Kröger, 2005, 2011) and aimed for mediating having fun while being physically active and sport specific skills. Methods of behavior therapy have been implemented in movement therapies to change particular behavior, such as daily activities. The 1,5 hour exercise program was offered twice per week for half a year.
  •   Arm 2: In dietetic treatment the concept of optimised mixed diet was implemented. Methods of behavior therapy were implemented in dietetic treatment to change particular behavior, e.g. eating behavior. Over a period of six month tere were eight 1,5 units of nutrition counselling partially together with their parents.
  •   Arm 3: In the combined group the children took part in the ball school program as well as the nutrition counselling together with their parents. The contents were equivalent to the ones of the ball school – and nutrition group (see Arm 1 and Arm 2).
  •   The control group did not participate at a special programm during the intervention period of six month.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control, No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The goals can be explained by the following hypotheses:
Effectivity hypothesis I:
There is an expected correlation between weight reduction and an improvement of the functional (flow-mediated vasodilatation), morphologic (intima media thickness) and biochemical parameters (lipid profile, insulin resistance, hs-CRP).
Effectivity hypothesis II:
There is an expected correlation between the improved function of the endothelium and the increased amount of physical activity or change in nutrition.
Determination of the flow-mediated vasodilatation (FMD) und intima media thickness (IMT):
Measurements were taken with high resolution ultrasonic sound with an integrated ECG (Kretz Voluson 730). A 12 MHz receiving transducer with a 0,1 mm resolution and a penetration depth of maximum 7,5 cm was used to take measurements from the brachial artery and carotids. The calculation of the lumen diameter results from the method of Wendelhag, information for the breadboard model is provided by Celemayer.
FMD: The subjects were measured fasting between 8 and 10 o’clock with at least 10 min of rest prior to the examination, first measurement after the rest, then a hyper systolic compression of 5 min, post ischemic scan 45, 90, 120 sec. after releasing the blood pressure cuff measured three times to determine the mean value.
IMT: Measuring the distance between the intima lumen and the media adventitia. The measurement took place on both sides at four different locations: carotid artery communis, Bifukation, carotid artery interna. IMT: mean value out of 8 measurements. In addition BMI, blood pressure and different blood values were measured.
The analyses were made at baseline and half a year later after the intervention.

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

Secondary Outcome

The sports scientific primary outcome criteria are differentiated in assumptions of overall motor skills and sport specific skills. The overall motor skills are expected to improve, e.g. the fine motor skills and general motor abilities and endurance, as well as psychosocial features such as the ability to concentrate or the self-concept. Advance in sport specific abilities like ball coordination, technical and tactical skills are expected as well.
In order to identify cardiopulmonary endurance performance capacity, the subjects had to perform a 6 minute run (Bös et al., 2001), to identify overall body coordination the subjects had to perform the body coordination test for children (BCC) (“Körperkoordinationstest für Kinder KTK”) by Schilling (1974). The motor test for four to six year old children (MOT 4-6) was applied to determine fine motor skills, this is a method to diagnose the stage of development of motor skills of kindergarten aged children (Zimmer & Volkamer, 1987). The MOT 4-6 consists of 18 tasks, 5 were selected in order to test the fine motor skills and ability to respond. Three exercises were selected from the diagnostic inventory of basic motor skills (DMB), to determine eye-hand-coordination, respectively visual motor skills combined with fine motor skills (Eggert, 2008). A total score of the fine motor skills was put together each out of the three exercises from the MOT 4-6 and DMB for statistical analysis. To determine the subjects’ performance in game sports, the children were put into small groups and took part in three games with different demands (hand, racket, foot), each game lasted for ten minutes. In order to analyze the game performance, the modified rating scale by Scholl (1986) was applied. The peer acceptance, the cognitive competence and the competence in sports was determined with the pictorial scale of perceived competence and social acceptance in the German version (PSCA-D)(Asendorf & Aken,1993).
In this present study, body awareness (self-assessment, ideal self-image, body contentment) was measured with the modified charts of body shapes / outlines (Radtke 2004) according to Collins (1991) with seven increments each for girls and boys (Radtke, 2004; Collins,1991).
Two aspects of the cognitive performance were determined. The differential performance test – KG (DL – KG) (Kleber et al., 1999) was used to measure performance during focused activity, the culture fair intelligence test (CFT) (Weiß & Jürgen, 1997; Weiß, 1998)was applied to measure overall intelligence. The performance diagnostics of sports medicine was done on a bicycle ergometer. The gradual increase of physical exercise up until maximum individual performance, heart rate and oxygen uptake were parameters they looked at to determine the physical performance capacity.
Simultaneously an ECG was recorded in order to measure the heart rate. Prior to the exercise, every three minutes during the exercise, at the end of the exercise during the time frame after the exercise blood pressure was taken. Any contraindication and dropout criteria for ergometries were maintained.
The additional secondary endpoint has got expectations as follows: the combined group (Arm 3) shows a higher weight reduction (SDS – BMI) compared to the ball school – and nutrition counselling group (Arm 1 and Arm 2) itself. The control group is expected to have the lowest weight reduction (SDS – BMI).
The analyses were made at baseline and half a year later after the intervention.

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

  • University Medical Center 
  • other 
  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2006/08/15
  •   120
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Age-appropriate body weight above the 90th percentile; age between 6 and 10 years old, respectively attending primary school; exclusion from general diseases after being examined in the clinic for child – and youth medical care; sufficient motivation also alongside with their parents; adequate understanding of the German language; letter of agreement by a legal guardian for taking part in the study

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

Exclusion Criteria

Exclusion of somatic cause of adiposity;
Exclusion of a relevant somatic disease;
Exclusion of regular administration of medication;
Mental retardation

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Sport und Sportwissenschaft
    • Im Neuenheimer Feld 700
    • 69120  Heidelberg
    • 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 other
    • Zentrum für Kinder- und Jugendmedizin
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinische Universitätsklinik (Krehl-Klinik)Abteilung Innere Medizin I und Klinische Chemie
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Medizinische Universitätsklinik, Innere Medizin VII, Sportmedizin
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Sport und Sportwissenschaft
    • Ms.  Dr.  Ulrike  Hegar 
    • Im Neuenheimer Feld 700
    • 69120  Heidelberg
    • 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
    • Institut für Sport und Sportwissenschaft
    • Ms.  Dr.  Ulrike  Hegar 
    • Im Neuenheimer Feld 700
    • 69120  Heidelberg
    • 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
    • Manfred Lautenschläger-Stiftung gGmbH
    • Mr.  Dr. h. c.  Manfred  Lautenschläger 
    • Ernst-Reuter-Str. 12
    • 69251  Gaiberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Günter Reimann-Dubbers Stiftung
    • Postfach 251331
    • 69080  Heidelberg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2010/08/29
end of 1:1-Block state
* This entry means the parameter is not applicable or has not been set.