ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000851268

Ethics application status

Approved

Date submitted

2/05/2018

Date registered

21/05/2018

Date last updated

28/09/2023

Date data sharing statement initially provided

30/11/2018

Date results information initially provided

30/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Maintain Your Brain (MYB): a 3-year study of a personalised online program to prevent cognitive decline and incident dementia amongst community dwelling 55-77 year olds.

Scientific title

Maintain Your Brain (MYB): a 3-year randomised controlled trial of individualised multi-modal eHealth interventions to prevent cognitive decline and incident dementia amongst community dwelling 55-77 year olds.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1182-5787

Trial acronym

MYB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Alzheimer's Disease

Condition category

Condition code

Neurological

Dementias

Neurological

Alzheimer's disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The MYB intervention comprises up to 4, 10-wk modules delivered quarterly in the first 12 months of the trial, with periodic boosters for modules where appropriate (up to 3 yrs follow-up). The modules are Physical Activity, Nutrition, Peace of Mind and Brain Training. Eligibility for each module is determined by baseline assessments and includes health conditions, physical activity, diet and mental activity. All modules are fully online and accessed through the MYB eHealth platform.
Physical Activity: Participants will receive personalised goals and feedback, and exercise information, to change behaviour. All goals, feedback and materials (videos, factsheets) are arranged around 3 exercise modalities: aerobic exercise, resistance training and balance training. The basic PA prescription aims to increase aerobic and resistance training to levels with a demonstrated positive impact on cognition and other health outcomes. Where feasible, progression to higher exercise intensities will be encouraged as this is also linked to improved cognition. Daily balance training exercises will also be incorporated. A behavioural change program is integrated by providing personalised goals, feedback, and encouraging activity logging. Procedure. The long-term goal for participants is 300 min/wk of moderate activity, 3 days/wk of vigorous resistance training and balance training every day. Over the initial 10wk module, activity levels (self-report) will be used to generate a personalised visual display of progress as well as a combination of short-term goals and feedback. Progression to the long-term goal will be achieved by first encouraging exercise at low frequencies/intensities for those not currently exercising, with the goal volume being reached over the first month. Once achieved, focus will then be on increasing intensity. Weekly logging will be encouraged, as well as use of an action plan both of which will be used to measure adherence. During follow-up, booster sessions will be added once a month (up to 3yrs), with activity logging (and therefore updated goals/feedback) also reduced.
The PA module is designed to be self-administered, with participants able to engage with materials (such as factsheets and videos) in their own time and as often as they like. Materials are developed by qualified exercise physiologists and can be added, removed or updated. The module will be supported by “module trainers” (qualified exercise physiologists) who will respond to participant questions or module issues.
Tailoring. The PA module can be adjusted based on risk of falls to ensure strength and balance are improved prior to engaging in aerobic activity. During annual assessments, participants could be reallocated to the main PA module if appropriate. Participants may also have their module adjusted during the study if any reported health events make continuing in the module unsafe.
Nutrition. An overall Mediterranean-based MYB Healthy Brain diet will be offered that incorporates elements of the DASH Diet and Australian Healthy Eating guidelines, while emphasising unique parts of the Mediterranean diet. The rationale for this is based on relevance to risks for cognitive decline, and at this time it is the dietary pattern most strongly associated with cognitive benefits in clinical trials.
Procedure. Personalised dietary messages and feedback are used to encourage adoption of a Mediterranean-based diet. All messages, feedback and materials (videos, recipes, etc) are arranged around 10 food groups (discretionary, animal protein, olive oil, nuts, vegetables, fruit, legumes, wholegrains, fish/seafood and water) within the Mediterranean Diet to provide smaller manageable targets for change. The Nutrition portal provides a personalised visual display of progress towards the ideal Mediterranean Diet based on weekly food logs. The combination of dietary messages and feedback will target the most poorly scored and crucial changes first, while ensuring participants only receive a manageable number of changes (max 4). If a participant does not make any changes for 2 wks, messages move onto other food groups and cycle back to unchanged groups if time is available. If a participant reaches a completed pyramid, maintenance will be encouraged.
During the initial 10-wks, participants are encouraged to log their diet adherence weekly, with dietary messages and feedback updating based on this. They are also encouraged to fill out an action plan for achieving each suggested change. During follow-up, booster sessions will be monthly, with food logging (and goals/feedback) also only monthly.
The module is self-administered with participants able to engage with materials in their own time and as often as they like. All content, designed by qualified dietitians, can be added, removed or updated. The module will be supported by “module trainers” (qualified dietitians) who will respond to participant questions or module issues. Tailoring. There are two planned modifications to the Nutrition module based on alcohol consumption and being underweight. If participants report a high rate of alcohol consumption, messages related to alcohol will be prioritised. If participants report low body weight they will receive modified advice. Allocation to these modified streams or to the main Nutrition module can also happen during follow-up (i.e. booster period). Besides these planned streams, participants could be removed from the module should medical events be reported that makes it unsafe for them to continue.
Peace of Mind. Participants who are currently depressed and/or anxious; and/or have ever been diagnosed/treated for depression and/or anxiety will have access to the “Mixed Depression & Anxiety” course. This course has been developed by the Clinical Research Unit for Anxiety and Depression (CRUfAD) at UNSW/St Vincent’s Hospital. During the module, participants will be able to contact CRUfAD staff with clinical and technical questions. CRUfAD staff and participants are also provided with information about changes in psychological distress.
Procedure. The course is self-paced and includes 6 lessons delivered over 10 wks. Lessons are completed independently and include: 1)Psychoeducation about anxiety & depression, identifying symptoms, the fight or flight response, controlled breathing, and physical activity/exercise; 2) Cognitive therapy components: education about the cognitive model, cognitive distortions, and introduction to thought monitoring; activity planning; 3) Thought challenging/cognitive restructuring; challenging positive & negative meta-cognitive beliefs about repetitive thinking; shifting attention, hunt for positives; 4) Education about avoidance and safety behaviours; graded exposure and structured problem solving; 5) Advanced graded exposure (imaginal exposure, interoceptive exposure); troubleshooting difficulties with graded exposure; 6) Relapse prevention. Adherence is measured by number of completed lessons (downloaded homework).
Brain Training. Participants with an at-risk cognitive profile will be eligible for this module. Participants will complete a fully online, automated personalised cognitive training program that is vertically and horizontally adaptive called “Brain Training System (BTS)”. That is, the training regime is defined on participant’s baseline cognitive profile and continues to evolve in response to within-training task performance. Individual cognitive exercises are run as Flash files as provided by our commercial partner (Synaptikon, trading as NeuroNation, Germany); more than 30 are available at the outset and will be supplemented during the trial. BTS has otherwise been originally designed, including the approach to exercise selection, streaming, feedback, coaching and social support.
Procedure. A participant’s cognitive profile is generated based on baseline cognitive tests. Profiles rank performance across cognitive domains (verbal executive, speed, verbal memory, visual executive, visual memory, visual attention). Initial exercise selection and streaming order will reflect this profile, preferentially targeting areas of weakness in the middle of the session. Exercise selection and streaming will be recalculated during training based on degree of improvement on exercises at the domain-level.
Exercises will be presented in 3 sessions/wk, translating to 30 sessions over 10 wks. Each session will last 45 mins and comprise 17 exercises. If participants miss sessions, they will remain available until completed. During follow-up, exercises will be offered once a month (up to 3-yrs). Cognitive training materials for each session will also be provided and can be accessed as many times as the participant wishes.
After completing the first 5 sessions, participants will receive a feedback performance graph that summarises their cognitive performance on each cognitive domain trained thus far. This performance graph will also indicate the range of scores for the top 25% highest performers in the module based on previous week’s sessions. Participants’ individual performance will be updated after completing each session and the top 25% range will be updated weekly.
To maximise adherence and motivation, BTS will deploy several socialisation and gaming strategies. This includes access to an online Trainer (researcher), prioritised for participants ‘red-flagged’ as struggling with engagement or performance. Video chat will be preferred for these interactions, but participants will also be able to contact module trainers via MYB’s online interface. Participants can also nominate friends or family members who will be advised via email when the participant reaches certain adherence milestones, with the aim of providing social support and encouragement and establishing a community of practice. The Brain Training module is therefore designed to be automatically adaptive to a participant’s baseline score and progress during training.

Intervention code [1]

Prevention

Intervention code [2]

Lifestyle

Comparator / control treatment

Participants in the control group will receive information organised in the same module topics as the intervention (Physical Activity, Nutrition, Brain Training, Peace of Mind). Participants will have access to modules based on their module eligibility and in a pseudo-random order as described in the previous section. This means they will receive information on up to four 10 week modules in the first 12 months.

For the Physical Activity, Nutrition and Peace of Mind modules, the information provided will be focused on existing health guidelines and general advice for achieving these targets. The Brain Training module will involve a brief task (such as showing videos with a brief quiz). Participants will access the 10-week modules via the MYB eHealth platform with new tasks or information sheets provided once a month. For the Physical Activity, Nutrition and Brain Training modules, these activities are then reduced to quarterly (i.e., boosters) for up to 3 years follow-up.

The control group will receive periodic emails reminding them to login to the MYB platform to access this information. All participants in a control module will receive the same information but may be removed from a module for safety reasons (e.g. a previously undisclosed/undiagnosed health issue that might prevent safe exercise).

Control group

Active

Outcomes

Primary outcome [1]

Change in cognition from baseline to 3 years.

We will test whether the groups show differential change over the study as indicated by the group by time interaction. In addition, we will test the group difference at 3 years as a planned comparison. The outcome is the overall composite domain score as measured by the MYB online cognitive test battery (“MYB Battery”). The overall composite will be calculated by averaging the three domain scores. Domains and tests in MYB are defined as: Complex attention (Cogstate Detection, Cogstate Identification); Executive Function (Cogstate One Back, Cambridge Brain Sciences Spatial (tokens) Search, Cambridge Brain Sciences Grammatical Reasoning) and Learning and Memory (Cogstate One Card Learning and Cambridge Brain Sciences Paired Associates). Two valid test scores per domain are required to generate a participant’s domain score at each time point. Individual test scores will be converted to standard scores and MYB baseline data will be used to determine any required age, sex and education adjustments.

Timepoint [1]

Baseline to three years

Secondary outcome [1]

Change in ANU Alzheimer's Dementia Risk Index Short Form (ANU-ADRI-SF) score

Timepoint [1]

Baseline to 3 years

Secondary outcome [2]

Change in Complex Attention (composite score of Cogstate Detection and Cogstate Identification)

Timepoint [2]

Baseline to 3 years

Secondary outcome [3]

Service utilisation identified through routinely collected linked data: hospital admissions, emergency department presentations, medical and social care services and prescribed medications

Timepoint [3]

3 years

Secondary outcome [4]

Costs of program as determined by quality adjusted life years (QALYs) based on MYB used resources (staff time) and intervention effect.

Timepoint [4]

3 years

Secondary outcome [5]

Compliance with the intervention and for each module undertaken. Data available will be number of logins to MYB eHealth platform, number of times activities were accessed and number of completed module tasks.

Timepoint [5]

Baseline to 3 year follow-up

Secondary outcome [6]

Change in waist circumference and BMI if overweight/obese (self-reported body measures in MYB Physical Activity questionnaire)

Timepoint [6]

Baseline to 3 year follow-up

Secondary outcome [7]

Change in level of physical activity (HAQ energy expenditure, stair climbing and walking, IPAQ sitting time)

Timepoint [7]

Baseline to 3 year follow-up

Secondary outcome [8]

Change in physical activity during the module as measured by the Short Physical Performance Battery Score

Timepoint [8]

Baseline to 3 year follow-up

Secondary outcome [9]

Adherence to the prescribed exercise program as measured by completion of weekly online activity logging.

Timepoint [9]

Baseline to 3 year follow-up

Secondary outcome [10]

Change in adherence to the Mediterranean diet (MEDAS index score/14)

Timepoint [10]

Baseline to 3 year follow-up

Secondary outcome [11]

Change in exposure to foods/culinary practices assessed via MediCul tool

Timepoint [11]

Baseline to 3 year follow-up

Secondary outcome [12]

Change in alcohol intake (ADRI-SF and Medicul)

Timepoint [12]

Baseline to 3 year follow-up

Secondary outcome [13]

Change in within task cognitive training performance (percentage correct per session).

Timepoint [13]

Baseline to 3 year follow-up

Secondary outcome [14]

Change in mental activity levels (LEQ late-life subscale)

Timepoint [14]

Baseline to 3 year follow-up

Secondary outcome [15]

Change in psychological distress (K10)

Timepoint [15]

Baseline to 3 year follow-up

Secondary outcome [16]

Change in module expectations as measured by the Module Expectations questionnaire (total).

Timepoint [16]

Pre and post (10 weeks) for each module

Secondary outcome [17]

Change in Executive Function (composite score of Cogstate One Back, Cambridge Brain Sciences Spatial (tokens) Search, Cambridge Brain Sciences Grammatical Reasoning)

Timepoint [17]

Baseline to 3 years

Secondary outcome [18]

Change in Learning and Memory (composite score of Cogstate One Card Learning and Cambridge Brain Sciences Paired Associates).

Timepoint [18]

baseline to 3 years

Secondary outcome [19]

Change in complex attention as measured by Cogstate Detection.

Timepoint [19]

baseline to 3 years

Secondary outcome [20]

Change in complex attention as measured by Cogstate Identification.

Timepoint [20]

from baseline to 3 years

Secondary outcome [21]

Change in executive function as measured by Cogstate One Back

Timepoint [21]

baseline to 3 years

Secondary outcome [22]

Change in executive function as measured by Cambridge Brain Sciences Spatial (tokens) Search.

Timepoint [22]

baseline to 3 years

Secondary outcome [23]

Change in executive function as measured by Cambridge Brain Sciences Grammatical Reasoning)

Timepoint [23]

baseline to 3 years

Secondary outcome [24]

Change in the domain 'learning and memory' as measured by Cogstate One Card Learning

Timepoint [24]

baseline to 3 years

Secondary outcome [25]

Change in the domain 'visuospatial learning and memory' as measured by Cambridge Brain Sciences Paired Associates

Timepoint [25]

baseline to 3 years

Secondary outcome [26]

Change in the domain 'verbal learning and memory' (as measured by LOGOS)

Timepoint [26]

baseline to 3 years

Secondary outcome [27]

Change in smoking status (ADRI-SF)

Timepoint [27]

3 years

Secondary outcome [28]

Engagement during Brain Training module (count use of social platform)

Timepoint [28]

Baseline to 3 years

Secondary outcome [29]

Number and type of adverse events such as hospitalisations, muscle soreness, food allergies (count based on medical events form)

Timepoint [29]

baseline to 3 years

Secondary outcome [30]

New chronic conditions (count based on medical history and medical events forms)

Timepoint [30]

baseline to 3 years

Secondary outcome [31]

Incident dementia as defined in MYB study. Dementia in MYB will be determined according to the following:
• Participants are screened for dementia at baseline via self-report questions and excluded. However, if it is identified via the processes below at follow-up, participants will be retrospectively censored as they cannot meet the definition of incident dementia.
• Dementia is assumed if there is any self-reported dementia to MYB via the medical history questionnaire (diagnosis or dementia medications), stated as a reason to withdraw from the trial, or it is otherwise reported to MYB that dementia has been confirmed by a medical professional.
• If there is no self-report, dementia will be assumed if any of the following available linkage data indicate dementia:
o Alzheimer medications on Pharmaceutical Benefits Scheme (PBS), (donepezil, galantamine or rivastigmine or memantine).
o Dementia listed on hospital records.
o Dementia listed on cause of death in death certificate records.
• If none of the above indicates dementia DSM-5 criteria requiring cognitive impairment and functional impairment will be applied.
o Cognitive impairment is measured by the MYB Battery and an additional automated telephone based verbal memory test (LOGOS).
o Cognitive impairment is defined as greater or equal to 2 SD below baseline on any individual test OR greater or equal to 1.5 SD below baseline in at least one domain
o Functional impairment is defined by the A-IADL-SF (cut off is less than 51.4).
• If there are no cognitive data, dementia will be “undetermined”.
• If there is evidence for cognitive impairment (defined above) but no data on function, participants will be classified as “impaired cognition, function undetermined”.

Timepoint [31]

Three years

Eligibility

Key inclusion criteria

• enrolled in the 45 and Up Study and agree to be contacted by them
• aged 55-77 in the year recruitment commences
• do not have dementia, Parkinson’s disease, Multiple Sclerosis (per available 45 and Up Study records)
• did not participate in any prior MYB validation or pilot studies

Minimum age

55 Years

Maximum age

77 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Do not respond to the invitation
• Are unwilling or unable to access trial tasks on the MYB eHealth platform.
• Have not completed all screening and baseline assessments by the MYB start date
• Are involved in another intervention trial involving exercise, brain training, diet, depression/anxiety treatment or any drug trial.
• Do not have home internet or computer access (computer or laptop).
• Have vision problems which prevent them from reading a computer screen or are otherwise unable to use a mouse/computer without assistance.
• Have a life threatening condition.
• Have any dementia, Parkinson’s disease, or Multiple sclerosis.
• Have ever been prescribed a medication used to treat Alzheimer’s disease.
• Have been hospitalised overnight (24 hours or greater) more than 6 times in the past 12 months.
• Report having had a stroke or heart attack in the previous 3 months.
• Have been diagnosed with brain cancer; or any current malignancy other than cancer that has been in remission for at least 5 years (and does not currently require continuing chemotherapy); or non-metastatic prostate or skin cancer.
• Have ever been diagnosed with bipolar disorder or schizophrenia.
• Have severe depression (PHQ9 greater than 19).
• Report having suicidal intent (e.g., PHQ9 item 9 greater than 1 and BDI item 9 greater than 1).
• Are unable to write/converse in English.
• Do not have at least two unique risk factors and are not eligible for at least two modules.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

All screening procedures and baseline assessments will occur prior to randomisation. Following these, randomisation will be done centrally by a computerised process.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants who provide informed consent, meet trial inclusion criteria and none of the exclusion criteria and complete all baseline assessments will be enrolled in the trial. Participants agreeing to be in MYB will be randomised (1:1 allocation ratio) using minimisation technique based on the following stratification variables:
• Age (55-65; 66-77) as of 01/01/2018
• Gender (Male, Female)
• Dementia risk as measured by Australian National University Alzheimer’s Disease Risk Index – short form (tertiles total risk score)
• Module eligibility (1 module; 2 modules; 3 modules; 4 modules)
Per the minimisation technique, a weighted-coefficient variable is used to assign the participants, of each profile, into intervention and control groups (1:1 allocation ratio). Randomisation will occur after baseline assessments have been completed.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size. We will have 80% power to detect significant group by time interaction in the MYB Battery, assuming linear change and a final difference of 0.1 SD if we have 1,714 people in each group (total N = 3,428) with type 1 error rate of 0.05. This assumes a within-subjects correlation of .6 and a Lear deterioration rate of 0.1. If we assume a 20% drop out rate of over the trial, we will need to recruit at least 2,143 people in each arm. With 2,143 participants per arm (4,285 in total), we will have 80% power to detect differences of at least 0.1 SD for continuous secondary outcomes.

Statistical analysis. Participants with at least 2 unique risk factors and eligibility for 2 modules will be included in the MYB analysis. The trial will be reported in accordance with the CONSORT guidelines. We will analyse all outcomes by the arm to which participants were allocated (i.e. intention to treat analyses). We will analyse the primary outcome, change in cognition, using linear mixed models to examine the treatment group by time interaction and will obtain a test of the difference between the groups at the end of the trial. We will also conduct analyses adjusting for baseline demographic variables. In addition, we will conduct subgroup analyses on the primary outcome to determine if there is effect modification by the number of risk factors at baseline (3 or 4 risk factors vs 2 risk factors). We expect change in cognition to show a normal distribution. However, if there are violations of the assumptions of linear mixed models, appropriate transformations or a generalised linear mixed model with an appropriate distribution will be used.

Secondary outcomes will be analysed using linear mixed models for continuous normally distributed outcomes or chi-squared tests for categorical outcomes. We will use nonparametric tests for analysing continuous outcomes if the assumption of normality is violated.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

28/05/2018

Actual

19/06/2018

Date of last participant enrolment

Anticipated

3/09/2018

Actual

15/10/2018

Date of last data collection

Anticipated

31/10/2023

Actual

Sample size

Target

8500

Accrual to date

Final

6236

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC)

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of New South Wales

Address

UNSW Australia
UNSW Sydney, NSW 2052
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales HREC Committee A

Ethics committee address [1]

UNSW Australia
UNSW Sydney, NSW 2052
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/04/2016

Approval date [1]

21/04/2016

Ethics approval number [1]

HC16252

Ethics committee name [2]

NSW Population & Health Services Research Ethics Committee

Ethics committee address [2]

PO Box 41, Alexandria NSW 1435
Level 9, 8 Central Ave,
Australian Technology Park,
Eveleigh NSW 2015

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

23/09/2016

Approval date [2]

05/10/2016

Ethics approval number [2]

016/03/636

Summary

Brief summary

MYB is a randomised controlled trial of multiple online interventions designed to target modifiable risk factors for Alzheimer’s disease and dementia. Risk factors to be addressed are physical inactivity, cognitive inactivity, depression/anxiety, overweight and obesity, and poor diet. Up to four intervention modules (physical activity, nutrition, brain training and peace of mind) will be administered based on individual risk profiles.

Each module will be initially delivered using MYB eHealth platform over 10 weeks. In this part of the intervention, participants complete their assigned modules back-to-back, noting that the total number of modules is variable depending on individual’s risk factors. In practice this will translate to a minimum of two modules and a maximum of four modules, over a maximum of 12 months. Booster sessions (specific to each module) and ongoing monitoring will then continue for three years. Follow-up assessments measuring these risk factors and cognition will be completed annually for three years. The control group (“information” group) will receive basic psychoeducation online about dementia risk factors via a website with set activities organised by corresponding module eligibility (i.e., information activities themed around peace of mind, brain training, nutrition and/or physical activity). They will otherwise undertake the same enrolment, baseline and annual follow-up assessments.

Trial website

www.maintainyourbrain.org

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Henry Brodaty

Address

Dementia Collaborative Research Centre
AGSM Bldg (G27)
UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 (2) 9385 2585

Fax

+61 (2) 9385 2200

[email protected]

Contact person for public queries

Name

Dr Megan Heffernan

Address

Dementia Collaborative Research Centre
AGSM Bldg (G27)
UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 (2) 9385 3098

Fax

+61 (2) 9385 2200

[email protected]

Contact person for scientific queries

Name

Dr Megan Heffernan

Address

Dementia Collaborative Research Centre
AGSM Bldg (G27)
UNSW AUSTRALIA
UNSW SYDNEY NSW 2052 AUSTRALIA

Country

Australia

Phone

+61 (2) 9385 3098

Fax

+61 (2) 9385 2200

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

As this was added after ethics approval and trial registration we will need to review how/if we can comply.

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

Source	Title	Year of Publication	DOI
Embase	Nutrition Module design in Maintain Your Brain: an internet-based randomised controlled trial to prevent cognitive decline and dementia.	2022	https://dx.doi.org/10.1017/S0007114521001859
Embase	Maintain Your Brain: Protocol of a 3-Year Randomized Controlled Trial of a Personalized Multi-Modal Digital Health Intervention to Prevent Cognitive Decline among Community Dwelling 55 to 77 Year Olds.	2019	https://dx.doi.org/10.3233/JAD-180572
Embase	World-Wide FINGERS Network: A global approach to risk reduction and prevention of dementia.	2020	https://dx.doi.org/10.1002/alz.12123

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically