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Cognition Intervention Study PLUS (CogniDO PLUS) (CogniDo)

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ClinicalTrials.gov Identifier: NCT02082444
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Research Institute of Child Nutrition, Dortmund

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Having Lunch Omitting Lunch Other: Skipping lunch Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Cognition Intervention Study PLUS (CogniDO PLUS): Short-term Effects of Lunch on Children's Executive Cognitive Functions
Study Start Date : November 2013
Actual Primary Completion Date : December 2013

Arm Intervention/treatment
Experimental: Having lunch/skipping lunch
Lunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.
Other: Skipping lunch
Other Name: Just water




Primary Outcome Measures :
  1. • 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.

    1. 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.
    2. 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.
    3. 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.

  2. • 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.

  3. • 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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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Metabolic diseases, epilepsy or special diet


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082444


Locations
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Germany
Research Institute of Child Nutrition, Dortmund
Dortmund, Germany, 44225
Sponsors and Collaborators
Research Institute of Child Nutrition, Dortmund
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Responsible Party: Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier: NCT02082444    
Other Study ID Numbers: CogPlus201314
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014