Cognition Intervention Study Dortmund (CogniDO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier:
NCT01401153
First received: July 19, 2011
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Cognition - Other
Other: Skipping lunch

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Cross-over Trial Determining the Short-term Effects of Lunch on Children's Cognitive Functioning

Further study details as provided by Research Institute of Child Nutrition, Dortmund:

Primary Outcome Measures:
  • Tonic Alertness (Mean Reaction Time) [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Mean reaction time to response to a simple visual stimulus without a preceding warning signal

  • Tonic Alertness (Deviation of Reaction Time) [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Deviation of reaction time --> logarithmic standard deviation of the reaction times

  • Tonic Alertness (Commission Errors) [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Reactions when no stimulus had been presented

  • Tonic Alertness (Omission Errors) [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Stimuli to which no reaction follows within 1.5s

  • Immediate Block Span [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    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)

  • Incorrect Immediate Block Span [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Number of sequences incorrectly reproduced

  • Correct Immediate Block Span [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Number of sequences correctly reproduced

  • Sequencing Errors [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Sequences including all the blocks of a prescribed sequence, but in the wrong order

  • Reactions [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)

  • Percentage Incorrect Reactions [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Percentage of incorrect reactions

  • Number Correct Reactions [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Number of correct reactions

  • Incorrect Reactions [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Number of incorrect reactions

  • Mean Time Correct Reactions [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Mean time to react correctly

  • Mean Time Incorrect Reactions [ Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch) ] [ Designated as safety issue: No ]
    Mean time to react incorrectly


Enrollment: 105
Study Start Date: May 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01401153

Sponsors and Collaborators
Research Institute of Child Nutrition, Dortmund
Investigators
Study Director: Mathilde Kersting, Prof. Dr. Research Institute of Child Nutrition, Dortmund
  More Information

No publications provided

Responsible Party: Research Institute of Child Nutrition, Dortmund
ClinicalTrials.gov Identifier: NCT01401153     History of Changes
Other Study ID Numbers: COG0611DO, 03MT110527328495
Study First Received: July 19, 2011
Results First Received: August 31, 2012
Last Updated: October 9, 2012
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on August 01, 2014