Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007234

Trial Description

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Title

Cognition Intervention Study PLUS (CogniDO PLUS): Short-term Effects of Lunch on Children's Executive Cognitive Functions

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Trial Acronym

CogniDo

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically
proven insights into cognitive effects of lunch to the existing recommendations for school
meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an
enhancement of CogniDo this study investigates the short-term effects of having school lunch
versus skipping it on children's executive cognitive functions in the afternoon. The study
was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215
children.

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Brief Summary in Scientific Language

Because of cerebral particularities, children may react highly sensitive to short-term
variations of nutrient supply. Therefore, an optimised composition of meals at favourable
mealtime should be considered for optimal cognitive performance. The increasing
implementation of all-day schools in Germany requires the children's catering for lunch at
school. However, the number of 'meal skippers' is increasing among children and adolescents.
Thus, the effect of skipping lunch at school on cognitive functioning is examined in this
experimental cross-over trial. As prior intake of food can have an influence on the
physiological effect of test meal, the children's dietary intake in the mid-morning is
standardized. The intervention is integrated in everyday school life:

9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m.
everyday school life, 12.25 p.m. either lunch (control) or water as a beverage (intervention
of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. computerized
tests of executive cognitive functioning, 2 p.m. lunch for the 'skipping meal'-group.
Parameters of cognition with relevance to everyday school life are measured by a
computerized test program developed by the Institute of Working Learning and Aging (Institut
für Arbeiten Lernen Altern, ALA). Usual eating behaviour, sleep behaviour, physical activity
and parental education were determined as control variables by questionnaires for children,
parents. Migration background was requested from teachers. Body Mass Index was calculated
based on measured height and weight.

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Organizational Data

  •   DRKS00007234
  •   2015/05/22
  •   2014/03/06
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT02082444  (ClinicalTrials.gov)
  •   CogPlus201314  (Research Institute of Child Nutrition, Dortmund)
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Health Condition or Problem studied

  •   Having Lunch
  •   Omitting Lunch
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Interventions/Observational Groups

  •   Other: Skipping lunch
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Crossover
  •   N/A
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Primary Outcome

- • Shifting; time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch); Measuring global task-switching costs by a three-part computer trial.
Non-switch, or 'repeated' condition: The digits from 1 to 26 are presented to the participant in a random order with the task to put them in order.
Non-switch, or 'repeated' condition: The letters from A to Z are presented to the participant in a random order with the task to put them in order.
switch: the digits from 1 to 13 and the letters from A to M are presented to the participant in a random order with the task to put them in following order: digit (starting at 1), letter (starting at A), next higher digit, following letter etc.
- • updating; time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch); Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
- • inhibition; time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch); In one item three superposed triangles are presented to the participants, each pointing independently either to the left or the right. In addition, only the triangle in the middle might have no top and, thus, neither pointing to the left nor the right. The participant is supposed to press the buttons left, right or no reaction according to the direction of the triangle in the middle. The outer triangles appear 0.5 ms before the one in the middle. In total, this trial consists of 102 items.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   [---]*
  •   2013/11/30
  •   193
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Inclusion Criteria

  •   Both, male and female
  •   10   Years
  •   13   Years
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Additional Inclusion Criteria

All fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents
and child

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Exclusion Criteria

Metabolic diseases, epilepsy or special diet

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Addresses

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    • Research Institute of Child Nutrition, Dortmund
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.