NCT02344056

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 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

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 29, 2016

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

December 15, 2014

Last Update Submit

April 28, 2016

Conditions

Cognitive Function

Keywords

Having LunchSkipping Lunch

Outcome Measures

Primary Outcomes (9)

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

    Measuring global task-switching costs by a three-part computer trial. 1. Non-switch: digits from 1 to 26 in random order are to put in order. 2. Non-switch: Same as a) with letters from A to Z 3. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

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

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

    Measuring global task-switching costs by a three-part computer trial. 1. Non-switch: digits from 1 to 26 in random order are to put in order. 2. Non-switch: Same as a) with letters from A to Z 3. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

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

  • Shifting: Change of total switch-costs [ms]

    Measuring global task-switching costs by a three-part computer trial. 1. Non-switch: digits from 1 to 26 in random order are to put in order. 2. Non-switch: Same as a) with letters from A to Z 3. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)

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

  • updating: change of ratio of missing [%]

    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 [%]

    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]

    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]

    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]

    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]

    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)

Study Arms (2)

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: Having lunch/skipping lunch

skipping lunch/having lunch

EXPERIMENTAL

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

Other: Skipping lunch/having lunch

Interventions

Having lunch/skipping lunchOTHER

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

having lunch/skipping lunch
Skipping lunch/having lunchOTHER

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

skipping lunch/having lunch

Eligibility Criteria

Age10 Years - 14 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 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

December 15, 2014

First Posted

January 22, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 29, 2016

Record last verified: 2015-05

Locations

DE(1)