Cognition Intervention Study Dortmund- Continued (Coco) (Coco)

April 28, 2016 updated by: Research Institute of Child Nutrition, Dortmund
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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dortmund, Germany, 44225
        • Research Institute of Child Nutrition, Dortmund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: 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.
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.
Other: 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.

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.

  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]
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.

  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]
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.

  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 [%]
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

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Child Nutrition, Dortmund

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 15, 2014

First Submitted That Met QC Criteria

January 16, 2015

First Posted (Estimate)

January 22, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RIChildNutrition

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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