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Trial registered on ANZCTR


Registration number
ACTRN12615000822583
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
10/08/2015
Date last updated
23/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Body, Brain, Life-Fit (BBL-FIT) Program - A pilot study to evaluate the feasibility of the BBL-FIT online lifestyle program in middle-aged adults at risk of dementia.
Scientific title
The Body, Brain, Life-Fit (BBL-Fit) Program - A pilot study to evaluate the feasibility of the BBL-Fit program, a multi-domain, online lifestyle intervention in middle-aged adults at risk of dementia.
Secondary ID [1] 287052 0
Nil
Universal Trial Number (UTN)
Trial acronym
BBL-Fit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's disease
 295532 0
Cognitive decline
 295799 0
Dementia 295800 0
Condition category
Condition code
Neurological 295807 295807 0 0
Alzheimer's disease
Neurological 295808 295808 0 0
Dementias
Neurological 295809 295809 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a pilot study of an intervention program called Body Brain Life-Fit (BBL-Fit). BBL-Fit includes education about dementia, online modules focussing on modifiable risk and protective factors that incorporate behaviour change components, a validated physical activity intervention and where indicated a diet intervention.

BBL-Fit is an intervention package that builds on two published interventions developed by our team: the BBL intervention (Trial ID:ACTRN12612000147886) and the Fitness for the Ageing Brain (FABs; Trial ID: ACTRN 12609000755235). We have revised our interventions to include newly available health self-monitoring technology, adapted our modules after extensive consumer evaluation, and included a more intensive physical activity program designed for a younger age-group. The sample will be middle-aged adults who have multiple risk factors for developing dementia but without a diagnosis of dementia or mild cognitive impairment (MCI).

Participants in the BBL-FIT group will required to complete 8 modules (dementia literacy, risk factors, physical activity, nutrition, health, cognitive activity, social activity and mood) delivered online, and receive an individually tailored one hour face to face physical activity session and where indicated an individually tailored one hour face to face dietary session. They will complete one module per week, each taking approximately 30-40 minutes. Participants will receive an email reminding them of the next module (during the first 8 weeks of the trial). Participants who are late competing modules will receive up to 3 reminder emails.

Duration and frequency of physical activity (PA) program will vary between participants. An exercise physiologist will deliver individual sessions, writing and supervise physical activity programs. For those not doing any regular PA at baseline, the target will be 150 minutes/week moderate intensity PA, for those doing less than 100 minutes/week, an additional 100 minutes/week will be prescribed and for those meeting the target, an additional 50 minutes/week will be prescribed. A diary in the format of a calendar will be used to record PA and rating of perceived exertion.

The dietary intervention will be provided to those individuals who have low (<20) or high (30+) BMI, have experience significant weight gain or loss in the last 6 months to 3 years or indicate an unhealthy dietary pattern at the baseline assessment. A one hour face to face intervention will involve individually tailored dietary advice, formal dietary prescription, and a dietician tailored plan. A diary similar to that for physical activity program will be used to record dietary pattern.

A pilot study will be conducted to evaluate the feasibility of the BBL-Fit with 40 participants aged 45-60 for a duration of 10 weeks.
Intervention code [1] 292275 0
Lifestyle
Intervention code [2] 292276 0
Behaviour
Intervention code [3] 292277 0
Prevention
Comparator / control treatment
Usual Care (UC): Participants allocated to the UC group proceed with their normal activities and access health services as required over the trial period. They will also receive a face to face risk reduction workshop approximately 12 weeks after the initial assessment, i.e. after all study time points have been completed. This workshop will provide the information contained in the BBL-Fit intervention as a mean of debriefing at the end of the intervention. This will provide extensive information on how to reduce risk of developing dementia.
Control group
Active

Outcomes
Primary outcome [1] 295504 0
The Primary Outcome measure is cognitive ability. Cognitive ability will be assessed by a composite of a subset of the Iowa Healthy and Active Minds Study (IHAMS) battery (Useful Field of View, Trail making A and B, Symbol Digit Modalities Test, Stroop Word) and a memory measure (Hopkins Verbal Learning Test).
Timepoint [1] 295504 0
Neuropsychological tests will be assessed at baseline and at 13 weeks (upon completion of the intervention).
Secondary outcome [1] 315718 0
Dementia risk will be assessed with the ANU-ADRI, a measure of Alzheimers Disease Risk that has been validated to predict AD and dementia incidence. The ANU-ADRI is comprised of validated scales assessing 15 individual risk and protective factors including the International Physical Activity Questionnaire to assess Physical Activity level. The factors assessed include age, sex, smoking, alcohol consumption, traumatic brain injury, diabetes, hypertension, high cholesterol, pesticide exposure, depression, social networks, cognitive activity, education level, physical activity and fish consumption.
Timepoint [1] 315718 0
Baseline and at 11 weeks
Secondary outcome [2] 315719 0
Moderate-vigorous Physical Activity (MVPA) is a continuous measure of activity that registers 3 or more Metabolic Equivalents of Task (METs) for 10 minutes or longer on a Sensewear, which is worn for 7 days at baseline and 11 weeks. MVPA will be recorded in both Control and BBL-Fit groups.
Timepoint [2] 315719 0
Baseline and at 11 weeks
Secondary outcome [3] 315720 0
Depressive symptoms score will be assessed with the Centre for Epidemiological Studies Depression Scale which is a continuous subscale of the ANU-ADRI.


Timepoint [3] 315720 0
Baseline and at 11 weeks

Eligibility
Key inclusion criteria
Persons aged 45 to 60, with presence of 3 or more of the following dementia risk factors (Formal educational attainment at high school level or less, overweight or obese body mass index (BMI), a history of diabetes, hypertension, high cholesterol, smoking and/or depression) and a maximum of one protective factors (high level of physical activity, high consumption of fish, cognitive engagement, and light to moderate alcohol consumption), and who live in the ACT and surrounding areas. All participants will be required to have internet access at home, be Australian permanent resident or citizen and agree to attend the Centre for Research on Ageing, Health, and wellbeing for two face to face assessments (baseline and 11 weeks) and a face to face workshop for those in UC group.
Minimum age
45 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of chronic or life-threatening medical conditions and psychiatric conditions that would prevent participation in the trial, sensory deficits or mobility limitations that would prevent or substantially restrict the delivery of the assessment or intervention, poor English language skills, cognitive impairment defined as MMSE <24 (we do not expect to identify any dementia cases as the sample is young).

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 Ageing, Health and Wellbeing. Following the baseline assessment, participants will be randomised into one of the 2 groups using a computer sequence generation by a member of research team who is not involved in testing of participants. Randomisation will be stratified by gender.
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 randomisation using a randomisation table created by computer software: computer sequence generation.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/08/2015
Actual
2/09/2015
Date of last participant enrolment
Anticipated
Actual
3/12/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 291608 0
Government body
Name [1] 291608 0
Dementia Collaborative Research Centre
Country [1] 291608 0
Australia
Primary sponsor type
Individual
Name
Professor Kaarin J Anstey
Address
Centre for Research on Ageing, Health and Wellbeing
Building 54, Mills Road
The Australian National University
Canberra 2601
ACT
Country
Australia
Secondary sponsor category [1] 290280 0
Individual
Name [1] 290280 0
Dr Sarang Kim
Address [1] 290280 0
Centre for Research on Ageing, Health and Wellbeing
Building 54, Mills Road
The Australian National University
Canberra 2601
ACT
Country [1] 290280 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293143 0
ANU Human Research Ethics Committee
Ethics committee address [1] 293143 0
Chancelry Lower10B
The Australian National University
Acton ACT 2601
Ethics committee country [1] 293143 0
Australia
Date submitted for ethics approval [1] 293143 0
10/06/2015
Approval date [1] 293143 0
17/08/2015
Ethics approval number [1] 293143 0
2015/214

Summary
Brief summary
This project is a pilot study of an intervention program called Body Brain Life-Fit (BBL-Fit). BBL-Fit aims to determine the effect of a multi-domain dementia risk reduction intervention on cognitive function in community dwelling middle-aged adults with multiple risk factors for dementia. The sample will be healthy but have several risk factors for dementia. The intervention is tailored to individuals based on their level of risk in particular domains. There will be two groups; a control group who receives a pre and post assessment without interventions, and an intervention group who receive online intervention as well as physical activity and dietary (where indicated) interventions.
Trial website
Trial related presentations / publications
Anstey, K., et al. (2015). "Body brain life: A randomized controlled trial of an online dementia risk reduction intervention in middle-aged adults at risk of Alzheimer's disease" Alzhiemer's & Dementia: Translational Research & Clinical Interventions 1: 72-80.

Anstey, K., et al. (2013). "A 12-week multidomain intervention versus active control to reduce risk of Alzheimer's disease: study protocol for a randomized controlled trial." Trials 14: 60.

Cyarto, E., et al. (2010). "The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease." Trials 11(1): 120.
Public notes

Contacts
Principal investigator
Name 58646 0
Prof Kaarin J Anstey
Address 58646 0
Centre for Research on Ageing, Health and Wellbeing
Building 54
Mills Road
The Australian National University
Canberra 2601
ACT
Country 58646 0
Australia
Phone 58646 0
+61 2 6125 8410
Fax 58646 0
Email 58646 0
[email protected]
Contact person for public queries
Name 58647 0
Sarang Kim
Address 58647 0
Centre for Research on Ageing, Health and Wellbeing
Building 54
Mills Road
The Australian National University
Canberra 2601
ACT
Country 58647 0
Australia
Phone 58647 0
+61 2 6125 0713
Fax 58647 0
Email 58647 0
[email protected]
Contact person for scientific queries
Name 58648 0
Kaarin J Anstey
Address 58648 0
Centre for Research on Ageing, Health and Wellbeing
Building 54
Mills Road
The Australian National University
Canberra 2601
ACT
Country 58648 0
Australia
Phone 58648 0
+61 2 6125 8410
Fax 58648 0
Email 58648 0
[email protected]

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