- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02082444
Cognition Intervention Study PLUS (CogniDO PLUS) (CogniDo)
Cognition Intervention Study PLUS (CogniDO PLUS): Short-term Effects of Lunch on Children's Executive Cognitive Functions
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Because of cerebral particularities, children may react highly sensitive to short-term 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. computerized tests of executive 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 program developed by the Institute of Working Learning and Aging (Institut für Arbeiten Lernen Altern, ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents. Migration background was requested from teachers. Body Mass Index was calculated based on measured height and weight.
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, epilepsy 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 |
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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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• Shifting
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
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Measuring global task-switching costs by a three-part computer trial.
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Participants were tested twice with one week wash out (1h after having/skipping lunch)
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• updating
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
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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.
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Participants were tested twice with one week wash out (1h after having/skipping lunch)
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• inhibition
Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
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In one item three superposed triangles are presented to the participants, each pointing independently either to the left or the right.
In addition, only the triangle in the middle might have no top and, thus, neither pointing to the left nor the right.
The participant is supposed to press the buttons left, right or no reaction according to the direction of the triangle in the middle.
The outer triangles appear 0.5 ms before the one in the middle.
In total, this trial consists of 102 items.
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Participants were tested twice with one week wash out (1h after having/skipping lunch)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary 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
Other Study ID Numbers
- CogPlus201314
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Clinical Trials on Skipping lunch
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Research Institute of Child Nutrition, DortmundCompleted
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Research Institute of Child Nutrition, DortmundCompletedCognition - Other
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University of HohenheimCompleted
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University of LiverpoolRecruitingObesity | Diet, Healthy | Eating BehaviorUnited Kingdom
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Research Institute of Child Nutrition, DortmundUnknownCognitive FunctionGermany
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International Centre for Diarrhoeal Disease Research...Completed
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Tampere UniversityCompletedExposure to Nature During Lunch Breaks | Relaxation Exercises During Lunch BreaksFinland
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Institut Pertanian BogorAjinomoto Co., Inc.UnknownAnemia | Stunting | UnderweightIndonesia
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University of Illinois at Urbana-ChampaignCompletedTime Constraints During School MealsUnited States
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University of BirminghamCompletedInhibition | Functional Magnetic Resonance Imaging | Eating Behavior | HungerUnited Kingdom