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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03255499




Registration number
NCT03255499
Ethics application status
Date submitted
11/08/2017
Date registered
21/08/2017

Titles & IDs
Public title
Efficacy of the MovinCog Intervention in Children
Scientific title
Efficacy of the MovinCog Intervention in Children: A Randomized, Placebo-controlled Trial
Secondary ID [1] 0 0
MC081017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Learning Disorders 0 0
Learning Disabilities 0 0
Cognitive Change 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Exercise
BEHAVIORAL - Cognitive
BEHAVIORAL - Active control

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.

Experimental: Exercise - High-intensity training regimen, 10min/day. Developed for the MovinCog intervention.

Experimental: Cognitive training - Computerized cognitive training, 20min/day. Developed for the MovinCog intervention.

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: Exercise
Exercise

BEHAVIORAL: Cognitive
Cognitive

BEHAVIORAL: Active control
Active control, including a blend of computer games, board games, quizzes, trivia
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline working memory capacity at 10 weeks
Timepoint [1] 0 0
Baseline and 10-week posttest
Primary outcome [2] 0 0
Change from baseline cognitive control at 10 weeks
Timepoint [2] 0 0
Baseline and 10-week posttest
Primary outcome [3] 0 0
Change from baseline scholastic aptitude at 10 weeks
Timepoint [3] 0 0
Baseline and 10-week posttest
Secondary outcome [1] 0 0
Change from baseline resting heart rate at 10 weeks
Timepoint [1] 0 0
Baseline and 10-week posttest
Secondary outcome [2] 0 0
BDNF polymorphism measured by genetic saliva kit
Timepoint [2] 0 0
Baseline

Eligibility
Key inclusion criteria
* Age 7-15
Minimum age
7 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Age outside inclusion criteria
* History of seizures, brain trauma

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Moreau
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Release IPD at the time of publication.

Supporting document/s available: Study protocol, Analytic code
When will data be available (start and end dates)?
Post-publication
Available to whom?
Unrestricted
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://github.com/davidmoreau/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03255499