NCT02082444

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

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
Last Updated

March 10, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

March 6, 2014

Last Update Submit

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

EXPERIMENTAL

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

Other: Skipping lunch

Interventions

Also known as: Just water
Having lunch/skipping lunch

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

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

Locations