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Trial registered on ANZCTR


Registration number
ACTRN12612000147886
Ethics application status
Approved
Date submitted
31/01/2012
Date registered
1/02/2012
Date last updated
25/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Body, Brain, Life Program –a prevention trial to reduce risk of Alzheimer's Disease
Scientific title
The Body, Brain, Life Program -Evaluation of a multi-domain, online lifestyle intervention in middle-aged adults at risk of Alzheimer’s
Secondary ID [1] 279829 0
NIL
Universal Trial Number (UTN)
U1111-1125-8325
Trial acronym
BBL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease 285714 0
Cognitive decline 285725 0
Dementia 285726 0
Condition category
Condition code
Neurological 285896 285896 0 0
Alzheimer's disease
Neurological 285908 285908 0 0
Dementias
Neurological 285909 285909 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BBL program is an online, theoretically-driven, multi-domain intervention comprising seven modules (Dementia literacy, Risk factors literacy, engagement in physical, cognitive, and social lifestyles, nutrition, and health monitoring and management). All modules were designed in a manner reflective of current theoretical models of health behaviour change, and with the exception of the first two modules which are primarily educational in nature, will be delivered in an individually-tailored manner.

The BBL program was designed to be delivered over 12 weeks, starting with the delivery of the seven modules once per week in a fixed order, and continuing with associated goal-related sessions in the remaining weeks. Participants in the intervention arms will be required to complete online activities 1 hour per week. They will be, however, encouraged to engage with the online material more frequently than that.

Arm1; This group will complete the online BBL program as described above over 12 weeks (one hour per week).

Arm2: This group will also complete the online BBL program over 12 weeks. However, this group will also participate in weekly face-to-face sessions to evaluate any additional effects of face-to-face contact, over and beyond the effects of the online trial only. Small face-to-face group sessions will be facilitated by a psychologist. The content of these sessions will largely echo the respective online modules. They will include discussion of the various risk factors, and will use motivational techniques to elicit group-level behavioural change dynamics. The small group element will be conducted weekly for 7 weeks with each week focusing on the topic of one of the online modules.]These face-to-face sessions will be of approximately one hour in duration.
Intervention code [1] 284149 0
Lifestyle
Intervention code [2] 284150 0
Behaviour
Intervention code [3] 284151 0
Prevention
Comparator / control treatment
Treatment as usual. This group will have no contact with the researchers other than for the baseline and follow-up assessments. At present, dementia risk is not routinely screened or flagged, and no standard form of care exists in relation to prevention/risk reduction. Hence, the control group will not receive any dementia-related information and lifestyle intervention as part of this trial. They may nevertheless explore dementia and risk-reduction strategies outside of the study context. They will be, however, advised not to enrol in a different trial of dementia prevention during the BBL trial period, or they will be exlcluded from follow-up analyses. The contents of the BBL program will be provided to the control participants in the form of a booklet at the conclusion of the trial.
Control group
Active

Outcomes
Primary outcome [1] 286393 0
Alzheimer's disease risk: The primary outcome measure of the trial will be reduction of risk of Alzheimer's disease in the intervention arms post-intervention and following a delay, as measured using the Australian National University Alzheimer's Disease Risk Index (ANU-ADRI). The ANU-ADRI was developed by the research group to assess risk of Alzheimer's disease based on self-reported measures of risk factors. Relative-risk algorithms for the ANU-ADRI were developed from a comprehensive meta-analysis and synthesis of risk factors from the literature. The ANU-ADRI provides an overall risk score, as well as domain- specific scores in respect to: a) Age b) Education, c) Body-Mass Index, d) Diabetes, e) Depression, f) high cholesterol, g) Traumatic Brain injury, h) Smoking, i) Alcohol intake, j) Social engagement k) physical activity, l) cognitive activity, m) Fish intake, n) Exposure to occupational pesticide. The ANU-ADRI was validated using data from three external longitudinal cohort studies: 1) Cardiovascular Health Study (CVHS): This large cohort study followed more than 5000 older persons from four US cities for 5 years to explore the association between cardiovascular health and the risk of incident AD. 2) The Rush Memory and Aging Project (MAP): Beginning in 1995, this is an ongoing longitudinal study involving more than 1000 non-demented community dwelling persons who agree to be follow-up to death and to donate their brain for histopathological examination. The study explores various risks for AD. 3) The Kungsholmen Project: A large longitudinal study in Sweden concerned with the identification of risk and protective factors for AD and in which community dwellers were followed from 1987 to 2000.
Timepoint [1] 286393 0
The ANU-ADRI will be used to assess risk for Alzheimer's disease at baseline, at 13 weeks (upon completion of the intervention), and at 26 weeks post baseline (three months post0intervention).
Secondary outcome [1] 295766 0
Psychological determinants of behaviour. A secondary outcome of the trial will be the extent to which any changes in lifestyle behaviours following the intervention will be underpinned by changes in the main determinants of behaviour as reflected in specific psychological questionnaires designed for each module. These questionnaires measure the main psychological determinants of behaviour, and were developed using contemporary models of health behaviour-change.
Timepoint [1] 295766 0
The behaviour specific questionnaires will be administered at the start of the respective behaviour change module as part of the intervention. The questionnaires will then be re-administered during the 26 weeks follow up.
Secondary outcome [2] 295767 0
Management of chronic medical conditions including hypertension, hypercholesterolemia, diabetes mellitus and depression. Evaluation of the degree of management of medical conditions will achieved by examination of blood and functional biomarkers (Blood pressure readings, HBA1C, serum cholesterol levels). Depressive symptoms will be assessed using Centre for Epidemiologic Studies Depression Scale (CES-D). Consistent with the literature using this measure, a cut-off of 16 will be used to identify individuals with symptoms in the clinical range of severity
Timepoint [2] 295767 0
Baseline and at 26 weeks
Secondary outcome [3] 295768 0
The impact of the intervention on performance on cognitive measures of speed and attention. Participants will undergo a cognitive evaluation including established pen-and-paper tests, as well as new or adapted online measures, including Symbol-Digit Matching Test, Trail Making Test, and Face-Name Learning Test. Participants will be given the option to complete a cognitive training package as part the intervention module.
Timepoint [3] 295768 0
Baseline and at the 26 week follow up

Eligibility
Key inclusion criteria
Persons aged 50 to 60, showing 3-4 AD modifiable risk factors on the ANU-ADRI, and who live in the ACT area. All participants will be required to have internet access at home, and they will need to agree to attend the Centre for Research on Aging, Health, and Wellbeing for two face-to-face assessments (baseline and 26 weeks)
Minimum age
50 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A diagnosis of any dementia, mild cognitive impairment, or cognitive impairment of any cause (MMSE<26).
History of neurological conditions likely to affect cognition (e.g., parkinsonism, traumatic brain injury, significant stroke)
Significant functional disabilities, for example due to hearing loss, vision impairment, or other medical events or procedures.
Significant psychological illness, for example due to psychosis, schizophrenia, or bipolar disorder.
No internet access at home,
Not fluent in English

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 who meet all inclusion and no exclusion criteria will be invited for the baseline evaluation at the Centre for Research on Aging, Health, and Wellbeing. Following the baseline assessment, participants will be randomised to one of the 3 groups using a computer program. Group allocation will then be concealed using sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial will involve simple randomization using a randomization table created by computer software: computer sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 4929 0
2580
Recruitment postcode(s) [2] 4930 0
2600- 2620
Recruitment postcode(s) [3] 4931 0
2900-2914

Funding & Sponsors
Funding source category [1] 284604 0
Government body
Name [1] 284604 0
Dementia Collaborative Research Centre
Address [1] 284604 0
63 Eggleston Rd., Acton
Canberra,
ACT 0200
Country [1] 284604 0
Australia
Primary sponsor type
Individual
Name
Professor Kaarin J anstey
Address
Centre for Research on Aging, Health, and Wellbeing
63 Eggleston Rd. Acton
The Australian National University
Canberra 0200
ACT
Country
Australia
Secondary sponsor category [1] 283524 0
Individual
Name [1] 283524 0
Dr Alex Bahar-Fuchs
Address [1] 283524 0
Centre for Research on Aging, Health, and Wellbeing
63 Eggleston Rd. Acton
The Australian National University
Canberra 0200
ACT
Country [1] 283524 0
Australia
Other collaborator category [1] 260480 0
Individual
Name [1] 260480 0
Professor George Rebok
Address [1] 260480 0
John Hopkins School of Public Health, 624 N. Broadwa, 8 Fl, Baltimore, MD 21205
Country [1] 260480 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286598 0
Human Research Ethics committee
Ethics committee address [1] 286598 0
Ethics committee country [1] 286598 0
Australia
Date submitted for ethics approval [1] 286598 0
22/12/2011
Approval date [1] 286598 0
10/02/2012
Ethics approval number [1] 286598 0
2011/609

Summary
Brief summary
This project is a randomised control trial of an online program that aims to reduce risk for Alzheimer’s disease (AD) by intervening in modifiable risk factors. The sample will be healthy but have several modifiable risk factors for AD. Hence this is classified as an indicated prevention trial. The intervention will educate individuals about AD and risks for AD. The intervention itself is tailored to individuals based on their readiness for change and level of risk in particular domains. There will be three groups; a control group who receives a pre and post assessment, an online only intervention group and an online plus small face-to-face intervention group. The trial involves 7 modules (one per week). Level of risk for AD will be assessed at baseline, 13 weeks and 26 weeks.
Trial website
Trial related presentations / publications
Anstey K J, Cherbuin N, Herath PM. National Dementia Research Forum, Interventions to prevent or delay the onset of dementia: Review 2011, 22-23 Sept. 2011, Sydney, Australia.

Herath PM, Anstey K J, Cherbuin N, National Dementia Research Forum, Development of ANU-Dementia Risk Index (ANU-DRI): Evidence based risk calculations for dementia, 22-23 Sept. 2011, Sydney, Australia.

Anstey K J, Cherbuin N, Herath PM. 1st International Conference in Translational Medicine (13th Frank and Bobbie Fenner Conference), PROACTA an online risk assessment tool for dementia and an evidence based intervention, 1-4 November 2010, Canberra, Australia
Public notes

Contacts
Principal investigator
Name 33702 0
Prof Kaarin Anstey
Address 33702 0
Centre for Research on Ageing, Health, and Wellbeing
54 Mills Rd.
Acton
The Australian National University
ACT 0200
Country 33702 0
Australia
Phone 33702 0
+61 2 61258410
Fax 33702 0
Email 33702 0
kaarin.anstey@anu.edu.au
Contact person for public queries
Name 16949 0
Dr Dr Alex Bahar-Fuchs
Address 16949 0
Centre for Research on Aging, Health, and Wellbeing. Building 63, Eggleston Rd.,
Australian National University, Acton,
ACT 0200
Country 16949 0
Australia
Phone 16949 0
+61 2 61259705
Fax 16949 0
+61 2 61250733
Email 16949 0
alex.baharfuchs@anu.edu.au
Contact person for scientific queries
Name 7877 0
Prof Prof Kaarin J Anstey
Address 7877 0
Centre for Research on Aging, Health, and Wellbeing. Building 63, Eggleston Rd.,
Australian National University,
Acton, ACT 0200
Country 7877 0
Australia
Phone 7877 0
+61 2 61258410
Fax 7877 0
+61 2 61250733
Email 7877 0
kaarin.anstey@anu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary