Cognition Intervention Study Dortmund (CogniDO)

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

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.

Study Overview

• Status: Completed
• Conditions: Cognition - Other
• Intervention / Treatment: Other: Skipping lunch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Metabolic diseases or special diet

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Research Institute of Child Nutrition, Dortmund
• Investigators: Study Director: Mathilde Kersting, Prof. Dr., Research Institute of Child Nutrition, Dortmund

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): November 9, 2012
• Last Update Submitted That Met QC Criteria: October 9, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: COG0611DO; 03MT110527328495 (Other Grant/Funding Number: Uniscientia Stiftung)