- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02344056
Cognition Intervention Study Dortmund- Continued (Coco) (Coco)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Dortmund, Germany, 44225
- Research Institute of Child Nutrition, Dortmund
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
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 at libitum was constantly available on both days.
|
Lunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.
|
|
Experimental: skipping lunch/having lunch
no lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days.
|
No lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
|
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.
|
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RIChildNutrition
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