Efficacy of the MovinCog Intervention in Children

November 5, 2020 updated by: David Moreau, University of Auckland, New Zealand

Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial

This study aims to test the efficacy of the MovinCog Intervention to enhance cognitive abilities in children 7-15 yrs. The intervention consists of two parts: a physical exercise regimen, based on high-intensity training, and a cognitive training component. The design will contrast the intervention with an active control group, matched for expectancy effects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Specifically, the investigators will compare both components together (exercise and cognitive training) against either one of the components (exercise alone, or cognitive training alone) and against an active control group. The study will include measures of scholastic aptitude, as well as of working memory and cognitive control (primary outcome measures), two cognitive abilities that are critical to daily life activities, and that respond well to training. In addition, the investigators will measure physiological responses to training, to monitor changes associated with exercise (secondary outcome measures). Finally, the investigators will relate training-specific improvements with transfer gains, to better model the interaction between training and transfer. This will provide a comprehensive understanding of the dynamics associated with the intervention.

Study Type

Interventional

Enrollment (Anticipated)

1000

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

  • New Zealand
      • Auckland, New Zealand, 1010
        • University of Auckland

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

7 years to 15 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 7-15

Exclusion Criteria:

  • Age outside inclusion criteria
  • History of seizures, brain trauma

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise and cognitive training
This intervention includes a combination of high-intensity exercise (10min/day) and computerized cognitive training (20min/day). The software for the latter has been developed by our group, and includes 8 mini-games targeting different cognitive abilities. Both are developed for the MovinCog intervention. The intervention is personalized, based on individual performance.
Behavioral: Exercise
Exercise
Behavioral: Cognitive
Cognitive
EXPERIMENTAL: Exercise
High-intensity training regimen, 10min/day. Developed for the MovinCog intervention.
Behavioral: Exercise
Exercise
EXPERIMENTAL: Cognitive training
Computerized cognitive training, 20min/day. Developed for the MovinCog intervention.
Behavioral: Cognitive
Cognitive
ACTIVE_COMPARATOR: Games
The active control is composed of a blend of board games, computer games, and trivia quizzes. Specific content is personalized based on individual preferences, so as to reflect the flexibility of the experimental arms.
Behavioral: Active control
Active control, including a blend of computer games, board games, quizzes, trivia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline working memory capacity at 10 weeks
Time Frame: Baseline and 10-week posttest
Constructs measured by multiple tasks (bds, corsi, n-back)
Baseline and 10-week posttest
Change from baseline cognitive control at 10 weeks
Time Frame: Baseline and 10-week posttest
Constructs measured by multiple tasks (flanker, go/no-go, stroop)
Baseline and 10-week posttest
Change from baseline scholastic aptitude at 10 weeks
Time Frame: Baseline and 10-week posttest
Constructs measured by multiple national (New Zealand), standardized tests
Baseline and 10-week posttest

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline resting heart rate at 10 weeks
Time Frame: Baseline and 10-week posttest
Measured by monitor
Baseline and 10-week posttest
BDNF polymorphism measured by genetic saliva kit
Time Frame: Baseline
Effect of BDNF polymorphism on primary outcomes
Baseline

Collaborators and Investigators

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

Sponsor

University of Auckland, New Zealand

Investigators

  • Principal Investigator: David Moreau, University of Auckland, New Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

September 10, 2017

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (ACTUAL)

August 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC081017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Release IPD at the time of publication.

IPD Sharing Time Frame

Post-publication

IPD Sharing Access Criteria

Unrestricted

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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