Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000817145
Ethics application status
Approved
Date submitted
21/05/2019
Date registered
4/06/2019
Date last updated
11/02/2021
Date data sharing statement initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The international Mind, Activities and urban Places study (iMAP study): Building the evidence base on the relationships between environment, active living and cognitive health
Scientific title
The international Mind, Activities and urban Places study (iMAP study): Building the evidence base on the relationships between environment, active living and cognitive health
Secondary ID [1] 298294 0
None
Universal Trial Number (UTN)
Trial acronym
The international Mind, Activities and urban Places Study (iMAP Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function
 312919 0
Brain health 312920 0
Health behaviors 312921 0
Environmental risk factors 312953 0
Condition category
Condition code
Mental Health 311413 311413 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 311414 311414 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This prospective multidisciplinary cohort study proposes to build the evidence base on the impacts of urban environments on cognitive health. This research will specifically study environmental factors that are amenable to change through small- and large-scale interventions and changes in policy in the sectors of urban planning, transportation, environmental protection and architecture. The environmental exposures that will be studied include: characteristics of the built environment (e.g., dwelling density, access to facilities, access to public transport, intersection density, visual complexity); characteristics of the natural environment (amount of green space and blue space); noise and air pollution. This study will collect two-year longitudinal environmental data on a sample of 50-79 year old community dwellers. Baseline data collection will be conducted in 2019/2021 and repeated after 24 months in 2021/2023.
Intervention code [1] 314529 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320134 0
Cognitive function assessed using the Digit Span Backwards test,
Timepoint [1] 320134 0
At baseline and at two year post-enrollment
Primary outcome [2] 320164 0
Brain health assessed using Magnetic Resonance Imaging (MRI) - structural brain connectivity
Timepoint [2] 320164 0
At baseline and at two year post-enrollment
Primary outcome [3] 320260 0
Brain health assessed using Magnetic Resonance Imaging (MRI) - white matter hyperintensities.
Timepoint [3] 320260 0
At baseline and at two year post-enrollment
Secondary outcome [1] 370666 0
Physical activity assessed using accelerometers (e.g., daily minutes of moderate-to-vigorous physical activity)
Timepoint [1] 370666 0
At baseline and at two year post-enrollment
Secondary outcome [2] 370748 0
Sedentary time assessed using inclinometers (activPAL).
Timepoint [2] 370748 0
At baseline and at two year post-enrollment
Secondary outcome [3] 370749 0
Sleep quality assessed using accelerometry (sleep time, waking after sleep onset).
Timepoint [3] 370749 0
At baseline and at two year post-enrollment
Secondary outcome [4] 370750 0
Social activities assessed via self-reports (frequency of social contacts)
Timepoint [4] 370750 0
At baseline and at two year post-enrollment
Secondary outcome [5] 370751 0
Cognitive activities (activities that engage and stimulate the brain, such as reading, learning a language, solving puzzles) assessed using self-reports (number of different types of activities and frequency)
Timepoint [5] 370751 0
At baseline and at two year post-enrollment
Secondary outcome [6] 371008 0
Cognitive function assessed using the Animal Naming Test - This is a primary outcome.
Timepoint [6] 371008 0
At baseline and at two year post-enrollment
Secondary outcome [7] 371009 0
Cognitive function assessed using the Color Trail Test - Part 2. This is a primary outcome.
Timepoint [7] 371009 0
At baseline and at two year post-enrollment
Secondary outcome [8] 371010 0
Cognitive function assessed using the Corsi Block Tapping Test. This is a primary outcome.
Timepoint [8] 371010 0
At baseline and at two year post-enrollment.
Secondary outcome [9] 371011 0
Cognitive function assessment using the Victoria Stroop Test. This is a primary outcome.
Timepoint [9] 371011 0
At baseline and at two year post-assessment.
Secondary outcome [10] 371012 0
Cognitive function assessment using the Symbol Digit Modality Test. This is a primary outcome.
Timepoint [10] 371012 0
At baseline and at two year post-assessment.
Secondary outcome [11] 371013 0
Brain health assessed using Magnetic Resonance Imaging (MRI) - microbleeds. This is a primary outcome.
Timepoint [11] 371013 0
At baseline and at two years post-enrollment.
Secondary outcome [12] 371014 0
Brain health assessed using Magnetic Resonance Imaging (MRI) - hippocampal volume. This is a primary outcome.
Timepoint [12] 371014 0
At baseline and at two year post-enrollment.
Secondary outcome [13] 371015 0
Brain health assessed using Magnetic Resonance Imaging (MRI) - cortical gray matter volume. This is a primary outcome.
Timepoint [13] 371015 0
At baseline and at two year post-enrollment.
Secondary outcome [14] 371016 0
Brain health assessed using Magnetic Resonance Imaging (MRI) - ventricular volume. This is a primary outcome.
Timepoint [14] 371016 0
At baseline and at two year post-enrollment.

Eligibility
Key inclusion criteria
50-79 year old community dwellers who are able to walk outside their home for at least 5 minutes without major difficulties, who are able to speak and write in English and without major diagnosed mental or physical health conditions.
Minimum age
50 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
All conditions need to be diagnosed by an appropriate health professional (e.g., general practitioner, neurologist, psychiatrist).

1. Cancer within the past 5 years (exceptions: surgically removed skin cancers and untreated prostate cancer)
2. Cerebral palsy
3. Colour blindness
4. Dementia
o Alzheimer’s disease (AD)
o Frontotemporal dementia (FTD)
o Lewy body disease
o Normal pressure Hydrocephalus
o Vascular dementia
o Any other dementia
5. Heart attack – if experienced significant loss of conscientiousness that resulted in brain injury or impairment
6. Medical conditions
o Lung disease (chronic & severe)
o Kidney disease (chronic & severe)
o Thyroid - hypothyroidism (e.g., Hashimoto’s disease) or hyperthyroidism (e.g., Graves disease)
7. Moderate or severe head injury (e.g., traumatic brain injury (TBI), acquired brain injury (ABI))
8. Mild cognitive impairment (MCI)
9. Neurological conditions
o Epilepsy
o History of stroke
o Huntington’s disease
o Multiple sclerosis (MS)
o Parkinson’s disease (PD)
o Prion diseases (e.g., Multiple system atrophy (MSA) or Creutzfeldt-Jakob disease (CJD))
o Any other neurological disorder (exception: migraine)
10. Psychiatric / psychological disorders
o Anxiety disorders (current diagnosis)
• Post-traumatic stress disorder
• Obsessive-compulsive disorder
• Any other anxiety disorder that significantly impacts day-to-day functioning (mild anxiety ok)
o Developmental disorders
• Autism spectrum disorder
• Attention-deficit / hyperactivity disorder (ADHD) (a.k.a. attention deficit disorder)
• Dyslexia (or Specific Learning Disorder (SLD) with reading difficulties)
• Any other learning disorder
o Impulse control disorder
o Mood disorder (current diagnosis)
• Bipolar disorder (a.k.a manic-depressive disorder)
• Major depression
• Any other form of depression
o Personality disorder
o Schizophrenia
11. Sleep apnoea
12. Substance use/abuse

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Associations between environmental attributes with levels and 24-month changes in cognitive function, lifestyle behaviors and brain health will be estimated using Generalized Additive Mixed Models (GAMMs) able to detect curvilinear relationships and account for Statistical Areas 1-level and person-level (repeated measures) clustering, and appropriate for data with different distributions. To avoid collinearity, composite measures of collinear variables will be included in multiple-predictor models. No correction for multiple testing will be adopted as this work is confirmatory and hypothesis based. Mediation analyses will be conducted using the product-of-coefficients method or joint-significance test. Moderating effects will be examined by adding appropriate interaction terms to the main effect GAMMs. Missing data will be addressed by multiple imputation techniques following best-practice procedures to minimize sources of bias. Directed Acyclic Graphs will be employed to select confounders to be included in the models described above.
Reasons for living in the (current) neighborhoods (e.g. health issues) and information on residential addresses in the last 10 years will be available and incorporated in the models. To address the issue of loss to follow-up associated with cognitive impairment, we will conduct sensitivity analyses. First, GAMMs will produce reliable estimates under the assumption of data missing at random. Then, we will use multilevel logistic regression to fit predictive models of drop-out at the second assessment and compute weights representing the inverse probability of attrition for each participant. These weights will be used in weighted GAMMs and will take into account drop-outs not missing at random. We will contrast the regression estimates from the two sets of models to quantify the bias due to selective attrition.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/06/2019
Actual
11/06/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
1800
Accrual to date
365
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 21513 0
Hong Kong
State/province [1] 21513 0
Hong Kong
Country [2] 21514 0
Spain
State/province [2] 21514 0
Barcelona

Funding & Sponsors
Funding source category [1] 302837 0
University
Name [1] 302837 0
Australian Catholic University Research Fund
Country [1] 302837 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
40 Edward Street, North Sydney, NSW 2060
Country
Australia
Secondary sponsor category [1] 302783 0
Government body
Name [1] 302783 0
Australian Research Council
Address [1] 302783 0
11 Lancaster Place, ACT 2609
Country [1] 302783 0
Australia
Secondary sponsor category [2] 302785 0
University
Name [2] 302785 0
Hong Kong University
Address [2] 302785 0
G/F, Patrick Manson Building (North Wing), 7 Sassoon Road, Pokfulam
Country [2] 302785 0
Hong Kong
Secondary sponsor category [3] 302786 0
Other Collaborative groups
Name [3] 302786 0
ISGlobal
Address [3] 302786 0
Rosselló, 132, 08036 Barcelona
Country [3] 302786 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303415 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 303415 0
Ethics committee country [1] 303415 0
Australia
Date submitted for ethics approval [1] 303415 0
31/08/2018
Approval date [1] 303415 0
18/10/2018
Ethics approval number [1] 303415 0
2018-191H

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

Contacts
Principal investigator
Name 93598 0
Prof Ester Cerin
Address 93598 0
Australian Catholic University
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street, Melbourne, VIC 3000
Country 93598 0
Australia
Phone 93598 0
+613 9230 8260
Fax 93598 0
Email 93598 0
[email protected]
Contact person for public queries
Name 93599 0
Ester Cerin
Address 93599 0
Australian Catholic University
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street, Melbourne, VIC 3000
Country 93599 0
Australia
Phone 93599 0
+613 9230 8260
Fax 93599 0
Email 93599 0
[email protected]
Contact person for scientific queries
Name 93600 0
Ester Cerin
Address 93600 0
Australian Catholic University
Mary MacKillop Institute for Health Research
Level 5, 215 Spring Street, Melbourne, VIC 3000
Country 93600 0
Australia
Phone 93600 0
+613 9230 8260
Fax 93600 0
Email 93600 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study will collect information on participants' locations visited during the monitoring period, including home and work addresses that can be linked to environmental risk factors. It will also collect information on participants' social networks. This is sensitive and confidential information.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInternational Mind, Activities and Urban Places (iMAP) study: Methods of a cohort study on environmental and lifestyle influences on brain and cognitive health.2020https://dx.doi.org/10.1136/bmjopen-2019-036607
N.B. These documents automatically identified may not have been verified by the study sponsor.