Cognition Intervention Study Dortmund

Study Overview
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Brief Summary
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Major aim of this study is to add scientifically proven insights into cognitive effects of meals to the existing recommendations for school meals in Germany. As a first step the short-term effects of skipping lunch on children's cognitive functioning in the afternoon will be examined in a cross-over trial. The study is conducted in a large comprehensive school in Gelsenkirchen (Germany) including about 150 children.

Detailed Description
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Because of cerebral particularities, children may react sensitive to short-term variations of nutrient supply. Therefore, an optimised composition of meals at nutritionally favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering at school. However, also the number of 'meal skippers' is increasing among children. Thus, the effect of skipping of the midday meal 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 morning is standardized. The intervention is integrated in the usual 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 only a non-caloric beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. computerized tests of 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 battery of the 'Wiener Testsystem'. Usual eating behaviour, sleep behaviour, physical activity, parental education and migration background are determined as control variables by questionnaires for children, parents and teachers. Beside the Body Mass Index, the individual IQ is measured by a paper-pencil-test.

Official Title
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Cross-over Trial Determining the Short-term Effects of Lunch on Children's Cognitive Functioning

Conditions
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Cognition - Other

Intervention / Treatment
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* Other: Skipping lunch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All sixth grade students of Gesamtschule Berger Feld with the consent of parents and child Exclusion Criteria: Metabolic diseases or special diet

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Having lunch/skipping lunch<br>Lunch ad libitum on test day 1 and no lunch on test day 2. Water available on both days. | Other: Skipping lunch<br>* Just water.<br>|
| Experimental: Skipping lunch/having lunch<br>No lunch on test day 1 and lunch ad libitum on test day 2. Water available on both days. | Other: Skipping lunch<br>* Just water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tonic Alertness (Mean Reaction Time) | Mean reaction time to response to a simple visual stimulus without a preceding warning signal | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Tonic Alertness (Deviation of Reaction Time) | Deviation of reaction time --> logarithmic standard deviation of the reaction times | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Tonic Alertness (Commission Errors) | Reactions when no stimulus had been presented | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Tonic Alertness (Omission Errors) | Stimuli to which no reaction follows within 1.5s | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Immediate Block Span | Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks) | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Incorrect Immediate Block Span | Number of sequences incorrectly reproduced | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Correct Immediate Block Span | Number of sequences correctly reproduced | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Sequencing Errors | Sequences including all the blocks of a prescribed sequence, but in the wrong order | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Reactions | Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not) | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Percentage Incorrect Reactions | Percentage of incorrect reactions | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Number Correct Reactions | Number of correct reactions | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Incorrect Reactions | Number of incorrect reactions | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Mean Time Correct Reactions | Mean time to react correctly | Participants were tested twice with one week wash out (1h after having/skipping lunch) | 
| Mean Time Incorrect Reactions | Mean time to react incorrectly | Participants were tested twice with one week wash out (1h after having/skipping lunch) |