N/A
N=121
Cognition Intervention Study Dortmund
Cognition - Other
Bottom Line
View on ClinicalTrials.gov: NCT01401153 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Tonic Alertness (Mean Reaction Time) — 281; 279 Milliseconds — p=0.79
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Skipping lunch (Other)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Research Institute of Child Nutrition, Dortmund
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tonic Alertness (Mean Reaction Time) |
281; 279 | 0.79 |
| PRIMARY Tonic Alertness (Deviation of Reaction Time) |
77; 84 | 0.07 |
| PRIMARY Tonic Alertness (Commission Errors) |
2; 2 | 0.61 |
| PRIMARY Tonic Alertness (Omission Errors) |
0; 0 | 0.03 sig |
| PRIMARY Immediate Block Span |
5; 5 | 0.25 |
| PRIMARY Incorrect Immediate Block Span |
2; 2 | 0.70 |
| PRIMARY Correct Immediate Block Span |
10; 10 | 0.33 |
| PRIMARY Sequencing Errors |
2; 2 | 0.63 |
| PRIMARY Reactions |
628; 638 | 0.62 |
| PRIMARY Percentage Incorrect Reactions |
4.7; 5.3 | 0.11 |
| PRIMARY Number Correct Reactions |
586; 594 | 0.45 |
| PRIMARY Incorrect Reactions |
30; 35 | 0.13 |
| PRIMARY Mean Time Correct Reactions |
0.6; 0.6 | 0.68 |
| PRIMARY Mean Time Incorrect Reactions |
0.5; 0.5 | 0.67 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- All sixth grade students of Gesamtschule Berger Feld with the consent of parents and child
Exclusion Criteria
- Metabolic diseases or special diet
Data sourced from ClinicalTrials.gov (NCT01401153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.