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Completed

NCT Number: NCT02344056

Cognition Intervention Study Dortmund- Continued (Coco)

The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive functions in the afternoon. The present Coco study connect this two previous studies and investigates the effect of having school lunch versus skipping it on children's basal and executive cognitive functions later in the afternoon.

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Key information

Conditions

Cognitive Function

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Child Nutrition, Dortmund

Dortmund, 44225, Germany

About this study

Because of cerebral particularities, children may react highly sensitive to variations of nutrient supply. Therefore, an optimised composition of meals at favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering for lunch at school. However, the number of 'meal skippers' is increasing among children and adolescents. Thus, the effect of skipping lunch 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 mid-morning is standardized. The intervention is integrated in 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 water as a beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. to 14.10 p.m. regular school lesson. 14.15 p.m. computerized tests of executive cognitive and basal (alertness) functioning, 3 p.m. lunch for the 'skipping meal'-group. Parameters of cognition with relevance to everyday school life are measured by a computerized test program developed by the Institute of Working Learning and Aging (ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Metabolic diseases or special diet

Treatment and study plan

Having lunch/skipping lunch

Other

Lunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.

Skipping lunch/having lunch

Other

No lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days.

Primary outcomes

  1. Shifting: Change of total reaction time for a) [ms]

    Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    Measuring global task-switching costs by a three-part computer trial.

    • Non-switch: digits from 1 to 26 in random order are to put in order.
    • Non-switch: Same as a) with letters from A to Z
    • switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

  2. Shifting: Change of total reaction time for b) [ms]

    Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    Measuring global task-switching costs by a three-part computer trial.

    • Non-switch: digits from 1 to 26 in random order are to put in order.
    • Non-switch: Same as a) with letters from A to Z
    • switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

  3. Shifting: Change of total switch-costs [ms]

    Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    Measuring global task-switching costs by a three-part computer trial.

    • Non-switch: digits from 1 to 26 in random order are to put in order.
    • Non-switch: Same as a) with letters from A to Z
    • switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

  4. updating: change of ratio of missing [%]

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.

  5. updating: change of ratio of false alarms [%]

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.

  6. updating: change of mean reaction time [ms]

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.

  7. tonic alertness: change of mean reaction time [ms]

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.

  8. tonic alertness: change of deviation of reaction time [ms]

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.

  9. tonic alertness:change of numbers of omission and commission errors [n]

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

    measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.

Sponsors and collaborators

Lead sponsor

Research Institute of Child Nutrition, Dortmund

Other

Registry information

Acronym: Coco

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 22, 2015
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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