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Trial registered on ANZCTR


Registration number
ACTRN12617000792325
Ethics application status
Approved
Date submitted
24/05/2017
Date registered
30/05/2017
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Dementia Risk Reduction Study for People Experiencing Cognitive Problems in Day to Day Life
Scientific title
A Randomised Controlled Trial Evaluating the Efficacy of Multidomain Dementia Risk Reduction for Cognitive Decline (BBL-CD)
Secondary ID [1] 291397 0
N/A
Universal Trial Number (UTN)
Trial acronym
BBL-CD
Linked study record
Precursor studies:
Body, Brain, Life (BBL): ACTRN12612000147886
BBL-FIT: ACTRN12615000822583
BBL-GP: ACTRN12616000868482

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 302413 0
Subjective cognitive decline 302414 0
Dementia 303451 0
Condition category
Condition code
Neurological 301984 301984 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise an online intervention complemented with face-to-face and phone meetings with a dietitian and exercise physiologist.
The intervention group will complete an 8 week intervention comprising online education modules complemented with active components facilitated by health professionals. Each week there will be a module or active component to be completed. Each module will take approximately 1 hour to complete and can be completed in as many as sittings as they choose. After the first introductory module, each educational module will be followed in the next week by the complementary active component covering the same topic and the last week will be a revision module covering all content.
The four online modules cover:
-Dementia risk and protective factors, literacy around dementia and cognitive impairment;
-Healthy eating and how to incorporate aspects of a Mediterranean diet into daily life;
-The concept of cognitive engagement and how to maintain mental stimulation through hobbies and habits; and
-What types of physical activity are required to reduce dementia risk and how to set and achieve goals.
These online modules are all based on evidence based dementia risk reduction.

Active components are started during the 8 week intervention period (during weeks listed below) and continued until the conclusion of the study (week 32):
-Diet (facilitated by a dietitian): Participants have a 1 hour dietitian consultation in week 3 about how to increase adherence to a Mediterranean diet. This is followed up by two, 30 minute phone calls at weeks 10 and 21. Adherence to the dietary intervention will be monitored the healthy eating quiz and a Mediterranean diet measure (full details under secondary outcomes).
-Cognitive Engagement (through online brain training website Brain HQ): From week 5 onwards participants complete two executive function tasks (Double Decision & Freeze Frame) and two memory tasks (Memory Grid & Syllable Stacks) for 30 minutes per task, per week (total 2 hours/week). Adherence to the cognitive engagement intervention will be monitored through the Brain HQ website (full details under secondary outcomes).
-Physical Exercise (facilitated by an exercise physiologist): Participants have a 1 hour exercise physiologist consultation in week 7. The exercise physiologist will create an exercise program with the participants, incorporating types of physical activity that the participant enjoys and are safe and appropriate for the participant's level of fitness and any medical conditions they may have. The eventual aim is to increase physical activity to 150 minutes of moderate exercise per week. The exercise physiologist follows up the participant with two, 30 minute phone calls at weeks 10 and 21. Adherence to the physical activity intervention will be monitored by physical activity calendars to be completed by participants (full details under secondary outcomes).
Intervention code [1] 297676 0
Prevention
Intervention code [2] 297677 0
Lifestyle
Intervention code [3] 297678 0
Behaviour
Comparator / control treatment
The control group will undertake the same online modules as the intervention group: dementia risk and protection, literacy around dementia and cognitive impairment; healthy eating and how to incorporate aspects of a Mediterranean diet into daily life; the concept of “cognitive engagement” and how to keep more mentally challenged through hobbies and habits; and what types of physical activity are required to reduce dementia risk and how to set these goals and reach them.

The control participants will receive only the educational modules and none of the active components.
Control group
Active

Outcomes
Primary outcome [1] 301506 0
ADAS-Cog Plus for MCI will be used to measure between-group differences in cognition and instrumental activities of daily living (IADLs) across the course of the intervention. This is a composite measure which includes 11 domains of cognition assessed by the standard ADAS-Cog with additional executive function measures and instrumental activities of daily living, not included in the standard ADAS-Cog.
(https://link.springer.com/article/10.1007/s11682-012-9166-3)
Timepoint [1] 301506 0
Baseline (week 0), immediate post-intervention (week 9), 3 month post-intervention (week 20), 6 month post-intervention (week 32)
Primary outcome [2] 301507 0
Australian National University- Alzheimer's Disease Risk Index (ANU-ADRI) will be used to measure between-group differences in dementia risk based on lifestyle factors across the course of the intervention.
(http://search.proquest.com/openview/d0beb15b484043588c7b6aa3dba36126/1?pq-origsite=gscholar&cbl=44709)
Timepoint [2] 301507 0
Baseline (week 0), immediate post-intervention (week 9), 3 month post-intervention (week 20), 6 month post-intervention (week 32)
Secondary outcome [1] 332875 0
Short Form 36-item (SF-36) Health Survey total and subscale scores will be used to measure between-group differences in general health outcomes across the course of the intervention. SF-36 scores are commonly used in research as they can be converted to quality of life years (QALYs) for cost-benefit analyses.
(http://www.jstor.org/stable/3765916?&seq=1#page_scan_tab_contents)
Timepoint [1] 332875 0
Baseline (week 0), immediate post-intervention (week 9), 3 month post-intervention (week 20), 6 month post-intervention (week 32)
Secondary outcome [2] 333463 0
Motivation to Change Lifestyle and Health Behaviours for Dementia Risk Reduction (MCLHB-DRR) scores will be used to measure between-group differences in motivation to make lifestyle changes across the course of the intervention.
(http://www.karger.com/Article/Abstract/362228)
Timepoint [2] 333463 0
Baseline (week 0), immediate post-intervention (week 9), 3 month post-intervention (week 20), 6 month post-intervention (week 32)
Secondary outcome [3] 333464 0
Healthy Eating Quiz (http://www.healthyeatingquiz.com.au) total scores will be used to measure between-group differences in diet across the course of the intervention.
Timepoint [3] 333464 0
Baseline (week 0), immediate post-intervention (week 9), 3 month post-intervention (week 20), 6 month post-intervention (week 32)
Secondary outcome [4] 333465 0
14 item Mediterranean diet measure will be used to measure between-group differences in adherence to a Mediterranean diet across the course of the intervention. This is a measure adapted from the PREDIMED study (http://jnnp.bmj.com/content/84/12/1318)
Timepoint [4] 333465 0
Baseline (week 0), immediate post-intervention (week 9), 3 month post-intervention (week 20), 6 month post-intervention (week 32)
Secondary outcome [5] 334163 0
Time spent on each Brain HQ task is recorded by the website daily for each participant in the intervention group. (The control condition does not use this website).
This is a process measure used to measure dosage of this intervention, rather than an outcome.
Timepoint [5] 334163 0
Recorded daily from active cognitive engagement component commencement until the end of the study (weeks 4-32).
Secondary outcome [6] 334164 0
Change in performance on each Brain HQ task is recorded by the website daily for each participant in the intervention group. (The control condition does not use this website).
This is a process measure used to measure dosage of this intervention, rather than an outcome.
Timepoint [6] 334164 0
Recorded daily from active cognitive engagement component commencement until the end of the study (weeks 4-32).
Secondary outcome [7] 335340 0
Daily exercise calendar is a self-report record of type, duration in minutes and effort level of activity to track weekly exercise. Developed and utilised in previous versions of BBL study.
The measure will be used to measure between-group differences in exercise across the course of the intervention.
Timepoint [7] 335340 0
Recorded daily for the duration of the study (weeks 0-32).

Eligibility
Key inclusion criteria
-Living in the Australian Capital Territory or Queanbeyan, New South Wales;
-Aged 65 years or over;
-Have internet access, a computer at home and sufficient English language skills;
-Prepared to make lifestyle changes to improve their health.
-Have a medical diagnosis of mild cognitive impairment OR meet the Jessen et al. (2014) criteria for subjective cognitive decline (clinically normal on objective assessment, self/informant reported decline, decline not better accounted for by major medical, neurological or psychiatric diagnosis)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Currently participating in any lifestyle change interventions
-Diagnosis of Alzheimer's disease or another form of dementia*
-Major mental, neurological or physical problems which would prevent them from taking part in a lifestyle change program.

*(People may have a diagnosis of mild cognitive impairment, but not dementia).

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)
Participants will be enrolled by the project manager (MM). Following baseline testing, a statistician not involved in any other aspects of the project will allocate participants to groups via computer generated allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation by computer software. Participants will be stratified by: gender (2 levels) and level of cognition (2 levels: highest 50% and lowest 50% ADAS-Cog Plus scores) and lifestyle risk (highest 50% and lowest 50% ANU-ADRI scores).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: From an initial recruitment of 120 participants (60 per group) an attrition rate of approximately 40% is expected. This will retain 36 participants per group at the final follow-up. This sample size will enable the detection of a difference between groups at six months of 0.70 standard deviations for primary and secondary outcomes, which equates to approximately 4.2 units for ADAS-Cog and 4.0 units on ANU-ADRI.

Analyses: Intention-to-treat analysis using linear mixed modelling to compare outcomes between intervention and control groups over time, adjusted for baseline values.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/06/2017
Actual
30/01/2018
Date of last participant enrolment
Anticipated
21/08/2017
Actual
5/03/2018
Date of last data collection
Anticipated
5/10/2018
Actual
Sample size
Target
120
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 15609 0
2600 - Canberra
Recruitment postcode(s) [2] 15610 0
2620 - Queanbeyan

Funding & Sponsors
Funding source category [1] 295869 0
Charities/Societies/Foundations
Name [1] 295869 0
Alzheimer's Australia Dementia Research Foundation
Country [1] 295869 0
Australia
Funding source category [2] 295941 0
University
Name [2] 295941 0
NHMRC Centre for Research Excellence in Cognitive Health (The Australian National University)
Country [2] 295941 0
Australia
Funding source category [3] 295942 0
Charities/Societies/Foundations
Name [3] 295942 0
Royal Commonwealth Society- 2017 Phyllis Montgomery Award
Country [3] 295942 0
Australia
Funding source category [4] 296183 0
Government body
Name [4] 296183 0
NHMRC Fellowship Funds
Country [4] 296183 0
Australia
Funding source category [5] 296308 0
University
Name [5] 296308 0
Dementia Collaborative Research Centre (The Australian National University)
Country [5] 296308 0
Australia
Primary sponsor type
University
Name
Centre for Research on Ageing, Health and Wellbeing (The Australian National University)
Address
Attn: Kaarin Anstey & Mitchell McMaster
Centre for Research on Ageing, Health and Wellbeing
Florey Bldg (#54), Mills Rd, The Australian National University
Acton, ACT, 2601
Country
Australia
Secondary sponsor category [1] 295080 0
Individual
Name [1] 295080 0
Mitchell McMaster (Project Manager)
Address [1] 295080 0
Centre for Research on Ageing, Health and Wellbeing
Florey Bldg (#54), Mills Rd, The Australian National University
Acton, ACT, 2601
Country [1] 295080 0
Australia
Other collaborator category [1] 279486 0
Individual
Name [1] 279486 0
Kaarin Anstey
Address [1] 279486 0
Centre for Research on Ageing, Health and Wellbeing
Florey Bldg (#54), Mills Rd, The Australian National University
Acton, ACT, 2601
Country [1] 279486 0
Australia
Other collaborator category [2] 279487 0
Individual
Name [2] 279487 0
Linda Clare
Address [2] 279487 0
The Centre for Research in Ageing and Cognitive Health
School of Psychology, University of Exeter,
Perry Road, Exeter EX4 4QG, United Kingdom
Country [2] 279487 0
United Kingdom
Other collaborator category [3] 279488 0
Individual
Name [3] 279488 0
Sarang Kim
Address [3] 279488 0
Centre for Research on Ageing, Health and Wellbeing
Florey Bldg (#54), Mills Rd, The Australian National University
Acton, ACT, 2601
Country [3] 279488 0
Australia
Other collaborator category [4] 279489 0
Individual
Name [4] 279489 0
Susan Torres
Address [4] 279489 0
Deakin University Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Country [4] 279489 0
Australia
Other collaborator category [5] 279490 0
Individual
Name [5] 279490 0
Catherine D'este
Address [5] 279490 0
National Centre for Epidemiology and Population Health
Research School of Population Health
62 Mills Road, The Australian National University
Acton ACT 0200
Country [5] 279490 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297151 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 297151 0
Research Integrity & Compliance
Research Services Division
Level 2, Birch Building 36
Science Road, ANU
The Australian National University
Acton ACT 2601
Ethics committee country [1] 297151 0
Australia
Date submitted for ethics approval [1] 297151 0
28/11/2016
Approval date [1] 297151 0
07/03/2017
Ethics approval number [1] 297151 0
2016/360

Summary
Brief summary
The Body, Brain, Life Program for Mild Cognitive Impairment (BBL-MCI) is an online lifestyle modification program for people with Mild Cognitive Impairment (MCI) and subjective cognitive decline (SCD). MCI is a condition in which there are cognitive deficits in memory and other areas of thought, but these deficits are not sufficient to meet the criteria of a dementia diagnosis. SCD is condition where people are aware of and are concerned about minor cognitive deficits in day to day life, most often memory. People with MCI and SCD are at increased risk of dementia and there is some overlap in these groups, both are being included in this project.
The aim of the study is to reduce dementia risk in these high risk groups and prevent further cognitive decline. The project will involve 4 online informational modules and 3 practical components. The online modules will be comprised of: A module on dementia literacy and risk factors; physical activity; diet and cognitive engagement. The practical components will enable participants to integrate physical activity, diet and cognitive engagement into their everyday lives.
There are two research aims in this project:
(i) Evaluate the effectiveness of BBL-MCI in the prevention of cognitive decline in individuals with MCI/SCD
(ii) Evaluate the effectiveness of BBL-MCI to reduce overall risk for Alzheimer's disease and dementia as measured on the ANU-ADRI.
Trial website
Trial related presentations / publications
Presentation: McMaster, M., Clare, L., Kim, S., & Anstey, K. J. (2016, November). Ageing Well Through the Prevention of Dementia: A Protocol For A Multidomain MCI Intervention. Paper presented at 15th National Emerging Researchers in Ageing Conference, Canberra, Australia.

Poster: McMaster, M., Clare, L., Kim, S., Torres, S., D'Este, C., & Anstey, K. J. (2017, July) A Protocol for a Randomised Controlled Trial of Multidomain Dementia Risk Reduction for Mild Cognitive Impairment. Poster Presented at 2017 Alzheimer's Association International Conference, London, UK.
Public notes

Contacts
Principal investigator
Name 73146 0
Mr Mitchell McMaster
Address 73146 0
Centre for Research on Ageing, Health & Wellbeing (CRAHW)
The Australian National University
Florey Building (Bldg 54), Mills Road, Acton
ACT 2601 Australia
Country 73146 0
Australia
Phone 73146 0
+61 2 61256351
Fax 73146 0
+61 2 61 251558
Email 73146 0
[email protected]
Contact person for public queries
Name 73147 0
Mitchell McMaster
Address 73147 0
Centre for Research on Ageing, Health & Wellbeing (CRAHW)
The Australian National University
Florey Building (Bldg 54), Mills Road, Acton
ACT 2601 Australia
Country 73147 0
Australia
Phone 73147 0
+61 2 61 256351
Fax 73147 0
+61 2 61 251558
Email 73147 0
[email protected]
Contact person for scientific queries
Name 73148 0
Mitchell McMaster
Address 73148 0
Centre for Research on Ageing, Health & Wellbeing (CRAHW)
The Australian National University
Florey Building (Bldg 54), Mills Road, Acton
ACT 2601 Australia
Country 73148 0
Australia
Phone 73148 0
+61 2 61256351
Fax 73148 0
+61 2 61 251558
Email 73148 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23503Study protocol-999999  

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4178Plain language summaryNo

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLifestyle Risk Factors and Cognitive Outcomes from the Multidomain Dementia Risk Reduction Randomized Controlled Trial, Body Brain Life for Cognitive Decline (BBL-CD).2020https://dx.doi.org/10.1111/jgs.16762
N.B. These documents automatically identified may not have been verified by the study sponsor.