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| ID | Type | Description | Link |
|---|---|---|---|
| 03MT110527328495 | Other Grant/Funding Number | Uniscientia Stiftung |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Having lunch/skipping lunch | Experimental | Lunch ad libitum on test day 1 and no lunch on test day 2. Water available on both days. |
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| Skipping lunch/having lunch | Experimental | No lunch on test day 1 and lunch ad libitum on test day 2. Water available on both days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skipping lunch | Other | Just water. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde Kersting, Prof. Dr. | Research Institute of Child Nutrition, Dortmund | Study Director |
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161 participants were assessed for eligibility; 40 children refused to participate; thus 121 children started the study; one-week wash out;
Participants recruited from a secondary all-day school in Gelsenkirchen, Germany in May 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Having Lunch | Lunch ad libitum (pasta Bolognese, apple and water) |
| FG001 | Skipping Lunch | No lunch (water) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Test Day |
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| Second Test Day |
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| ID | Title | Description |
|---|---|---|
| BG000 | Having Lunch | Lunch ad libitum (pasta Bolognese, apple and water) |
| BG001 | Skipping Lunch | No lunch (water) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tonic Alertness (Mean Reaction Time) | Mean reaction time to response to a simple visual stimulus without a preceding warning signal | Complete case analysis | Posted | Median | Inter-Quartile Range | Milliseconds | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Having Lunch | Lunch ad libitum |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Mathilde Kersting | Research Institute of Child Nutrition | +49-231-792210-18 | kersting@fke-do.de |
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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) |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Primary | Tonic Alertness (Deviation of Reaction Time) | Deviation of reaction time --> logarithmic standard deviation of the reaction times | Complete case analysis | Posted | Median | Inter-Quartile Range | Unitless | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Tonic Alertness (Commission Errors) | Reactions when no stimulus had been presented | Complete case analysis | Posted | Median | Inter-Quartile Range | Commission errors | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Tonic Alertness (Omission Errors) | Stimuli to which no reaction follows within 1.5s | Complete case analysis | Posted | Median | Inter-Quartile Range | Omission errors | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | 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) | Complete case analysis | Posted | Median | Inter-Quartile Range | Longest sequence correctly reproduced | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Incorrect Immediate Block Span | Number of sequences incorrectly reproduced | Complete case analysis | Posted | Median | Inter-Quartile Range | Sequences incorrectly reproduced | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Correct Immediate Block Span | Number of sequences correctly reproduced | Complete case analysis | Posted | Median | Inter-Quartile Range | Sequences correctly reproduced | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Sequencing Errors | Sequences including all the blocks of a prescribed sequence, but in the wrong order | Complete case analysis | Posted | Median | Inter-Quartile Range | Sequences with wrong order | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Reactions | Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not) | Complete case analysis | Posted | Median | Inter-Quartile Range | Total reactions | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Percentage Incorrect Reactions | Percentage of incorrect reactions | Complete case analysis | Posted | Median | Inter-Quartile Range | Incorrect reactions % | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Number Correct Reactions | Number of correct reactions | Complete case analysis | Posted | Median | Inter-Quartile Range | Correct reactions | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Incorrect Reactions | Number of incorrect reactions | Complete case analysis | Posted | Median | Inter-Quartile Range | Incorrect reactions | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Mean Time Correct Reactions | Mean time to react correctly | Complete case analysis | Posted | Median | Inter-Quartile Range | Seconds | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| Primary | Mean Time Incorrect Reactions | Mean time to react incorrectly | Complete case analysis | Posted | Median | Inter-Quartile Range | Seconds | Participants were tested twice with one week wash out (1h after having/skipping lunch) |
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| 0 |
| 105 |
| 0 |
| 105 |
| EG001 | Skipping Lunch | No lunch (water) | 0 | 105 | 0 | 105 |
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