Efficacy of the MovinCog Intervention in Children

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: Cognitive Change; Learning Disabilities; Learning Disorders
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Cognitive; Behavioral: Active control

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	Constructs measured by multiple tasks (bds, corsi, n-back)	Baseline and 10-week posttest
Change from baseline cognitive control at 10 weeks	Constructs measured by multiple tasks (flanker, go/no-go, stroop)	Baseline and 10-week posttest
Change from baseline scholastic aptitude at 10 weeks	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	Measured by monitor	Baseline and 10-week posttest
BDNF polymorphism measured by genetic saliva kit	Effect of BDNF polymorphism on primary outcomes	Baseline

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Moreau D, Kirk IJ, Waldie KE. High-intensity training enhances executive function in children in a randomized, placebo-controlled trial. Elife. 2017 Aug 22;6:e25062. doi: 10.7554/eLife.25062.

Study record dates

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: cognitive training; physical exercise; cognitive abilities; brain dynamics; physiological markers
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Learning Disabilities
• 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