Cognition Intervention Study PLUS (CogniDO PLUS)
CogniDo
1 other identifier
interventional
193
1 country
1
Brief Summary
Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically proven insights into cognitive effects of lunch to the existing recommendations for school meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an enhancement of CogniDo this study investigates the short-term effects of having school lunch versus skipping it on children's executive cognitive functions in the afternoon. The study was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215 children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 6, 2014
CompletedFirst Posted
Study publicly available on registry
March 10, 2014
CompletedMarch 10, 2014
March 1, 2014
1 month
March 6, 2014
March 7, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
• Shifting
Measuring global task-switching costs by a three-part computer trial. 1. Non-switch, or 'repeated' condition: The digits from 1 to 26 are presented to the participant in a random order with the task to put them in order. 2. Non-switch, or 'repeated' condition: The letters from A to Z are presented to the participant in a random order with the task to put them in order. 3. switch: the digits from 1 to 13 and the letters from A to M are presented to the participant in a random order with the task to put them in following order: digit (starting at 1), letter (starting at A), next higher digit, following letter etc.
Participants were tested twice with one week wash out (1h after having/skipping lunch)
• updating
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.
Participants were tested twice with one week wash out (1h after having/skipping lunch)
• inhibition
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.
Participants were tested twice with one week wash out (1h after having/skipping lunch)
Study Arms (1)
Having lunch/skipping lunch
EXPERIMENTALLunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.
Interventions
Eligibility Criteria
You may qualify if:
- All fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child
You may not qualify if:
- Metabolic diseases, epilepsy or special diet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute of Child Nutrition, Dortmund
Dortmund, 44225, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2014
First Posted
March 10, 2014
Study Start
November 1, 2013
Primary Completion
December 1, 2013
Last Updated
March 10, 2014
Record last verified: 2014-03