Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000868482
Ethics application status
Approved
Date submitted
19/06/2016
Date registered
4/07/2016
Date last updated
29/07/2019
Date data sharing statement initially provided
29/07/2019
Date results information initially provided
29/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of health promotion interventions in adults with lifestyle and health risk factors for dementia
Scientific title
Efficacy of health promotion interventions in adults with risk factors for dementia: comparison of the Individualised Body Brain Life - GP (BBL-GP) program and a Group-based and Lifestyle Modification Program (LMP), with a control program of weekly emails on healthy lifestyle.
Secondary ID [1] 289128 0
None
Universal Trial Number (UTN)
Trial acronym
e3-LMPs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk of Alzheimer's disease and dementia 298608 0
Unhealthy lifestyle 298609 0
Cognitive decline 298610 0
Cardiovascular disease risk 299157 0
Condition category
Condition code
Neurological 298677 298677 0 0
Alzheimer's disease
Public Health 298678 298678 0 0
Health promotion/education
Neurological 298679 298679 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project compares three different interventions: a risk reduction intervention called Body Brain Life-GP (BBL-GP) that is designed to reduce risk of cognitive decline; a Lifestyle Modification Program (LMP) that is designed to enhance general wellbeing and improve lifestyle to reduce risk of chronic disease, once a week making a total of six sessions; and an Active Control condition involving emails containing information about healthy lifestyle.

BBL-GP 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). For BBL-GP we revised our previously published interventions to include newly available health self-monitoring technology, we adapted our modules after extensive consumer evaluation, and included a more intensive physical activity program designed for a younger age-group. This revised program (Body Brain Life-Fit) was piloted with the general public (Trial ID: ACTRN12615000822583). The sample for the current project is adults in Primary Care who meet criteria to participate in the GP Practice's Lifestyle Management Program. These are the types of adults who a GP would refer to a dementia risk reduction trial in 'real life' and we are aiming to evaluate our intervention in a naturalistic context. Primary care is the appropriate setting for the implementation of this program because it is where adults with high risk of developing dementia are identified.

Participants in the BBL-GP group will be 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 nutrition intervention. 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. The first eight weeks will be spent completing the 8 modules and the following four weeks will be spent revising the materials in the modules.

The session duration and frequency of the physical activity (PA) program will vary between participants based on individual tailoring. An exercise physiologist/physiotherapist will design an individual program for the participant, deliver this in a face-to-face workshop and monitor the physical activity program via the returned diaries and telephone monitoring. 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 returned monthly for 24 weeks, will be used to record PA and rating of perceived exertion.

The dietary intervention will be provided to those individuals who have experienced significant weight gain in the last 6 months 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 dietitian tailored plan. Participants will complete an online diary to record their dietary intake.

Participants in the BBL group will be asked to continue being active and having a healthy dietary pattern after the completion of the intervention but they will be monitored through phone calls at week 4, 12 and 20. In addition, they will receive a general booster session at 12 months with a phone call and a mailed out booklet.

Participants in the LMP group will receive group sessions on basic nutrition, meal planning, physical activity, health conditions, motivation and goals, medications, and sleep. This program will be provided by various health professionals (dietitian, exercise physiologist, nurse practitioner, psychologist, pharmacist and sleep physician) for a duration of 6 weeks. Each session will last for 2 hours. The course is currently run by the practice for their patients to assist them to improve their lifestyle and management of chronic disease and so it is a real-life comparison condition.

This trial will be conducted to evaluate the efficacy of health promotion interventions (BBL-GP and LMP) compared with the Active Control. There will be 240 participants (80 in BBL-GP, 80 in LMP and 80 in the Actvie Control group) followed for 62 weeks from baseline. There will be 4 follow-up assessments (immediately after the completion of the intervention or at 13 weeks for the Active Control, and at 18, 36 and 62 weeks after commencement of the intervention).
Intervention code [1] 294634 0
Lifestyle
Intervention code [2] 294635 0
Behaviour
Intervention code [3] 294636 0
Prevention
Comparator / control treatment
Participants allocated to the Actvie Control group proceed with their normal activities and access health services as required over the trial period. They will also receive weekly emails with links to websites providing information on lifestyle risk factors and disease management for a duration of 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 298170 0
The Primary Outcome measure is the score on the ANU-ADRI. The ANU-ADRI is comprised of validated scales assessing 15 individual risk and protective factors for Alzhiemer's disease and dementia.
Timepoint [1] 298170 0
ANU-ADRI assessments will be assessed at baseline, immediately after the intervention for LMP and BBL groups, and 13 weeks for the Active control. The Active control assessment is aligned with the BBL time-point for followup at 13 weeks immediately post intervention. The LMP and BBL interventions are of different lengths (6 and 12 weeks). We have decided that it is more important to capture change immediately post intervention for all groups, than to align the time point for the first follow-up. (It is not possible for us to do both). This is a constraint of conducting a trial in a real-life setting and comparing BBL-GP to an existing program. Follow-ups will also occur for all 3 groups at 18, 36 and 62 weeks after commencement of the intervention.
Secondary outcome [1] 323359 0
Cognitive function will be assessed with tests of processing speed and task switching using Trail A and B, and Digit Symbol Modalities Test.
Timepoint [1] 323359 0
Baseline for all groups, immediately after the intervention for the BBL and LMP groups and at 13 weeks for the Active Control, and for all groups assessments will also be made at 18, 36 and 62 weeks after commencement of the intervention.
Secondary outcome [2] 323362 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 an ActiGraph Link (http://actigraphcorp.com/products/actigraph-link/), which is worn for 7 days at baseline and at 18, 36, and 62 weeks follow ups. MVPA will be recorded in all three groups. Self-reported phyical activity will also be recorded using the IPAQ which is part of the ANU-ADRI.
Timepoint [2] 323362 0
Baseline for all groups, immediately after the intervention for the BBL and LMP groups and at 13 weeks for the Active Control, and for all groups assessments will also be made at 18, 36 and 62 weeks after commencement of the intervention.
Secondary outcome [3] 323363 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] 323363 0
Baseline for all groups, immediately after the intervention for the BBL and LMP groups and at 13 weeks for the Active Control, and for all groups assessments will also be made at 18, 36 and 62 weeks after commencement of the intervention.
Secondary outcome [4] 324866 0
Cost evaluation of two health promotion interventions. Health outcomes will be assessed with SF12 health survey, Framingham coronary heart disease risk score, and Australian type 2 diabetes risk assessment tool (Ausdrisk).
Timepoint [4] 324866 0
Baseline for all groups and 18, 36 and 62 weeks after commencement of the intervention.
Secondary outcome [5] 324941 0
Diet quality will be assessed with Healthy Eating Quiz (http://healthyeatingquiz.com.au/)
Timepoint [5] 324941 0
Baseline for all groups, immediately after the intervention for the BBL and LMP groups and at 13 weeks for the Active Control, and for all groups assessments will also be made at 18, 36 and 62 weeks after commencement of the intervention.
Secondary outcome [6] 337952 0
Sleep quality will be assessed with Pittsburgh Sleep Quality Index (PSQI).
Timepoint [6] 337952 0
Baseline for all groups, immediately after the intervention for the BBL and LMP groups and at 13 weeks for the Active Control, and for all groups assessments will also be made at 18, 36 and 62 weeks after commencement of the intervention.

Eligibility
Key inclusion criteria
Inclusion criteria are those used by the General Practice for referring patients to the Practice's Lifestyle Management Program which it offers for free. Adults who are overweight or obese (BMI (kg/m2)>= 25 and <=35), with a chronic health condition (such as high blood pressure, heart disease, type 2 diabetes or 'pre-diabetes', osteoporosis, osteoarthritis, PCOS, kidney or liver disease, depression/anxiety) and who live in the ACT and surrounding areas. In addition for our project, all participants will be required to have internet access at home, and agree to participate in the baseline and four follow-up assessments.

Note: The LMP program involves a baseline and followup assessment when offered (i.e. not as a research condition) and patients are evaluted on outcomes in usual care, so the assessments for this trial were designed to coincide with usual care as far as possible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of 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.

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 National Health Co-op. Following the baseline assessment, participants will be randomised into one of the 3 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 and age.
Group allocation will then be concealed using sealed envelopes.e.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial will use computer generated randomisation procedure, stratified by gender and age.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary analysis will include all available data (a modified Intention to treat), and will involve linear mixed models. Sensitivity analyses using multiple imputation will be undertaken to account for missing data.

Sample size calculations were estimated using G*power (version 3.1.). To detect a medium effect in a three-group design (1:1:1), with a 5% risk of type 1 error, 80% power and 4 measurements, a total sample size of 159 persons is required. Previous LMP had attribution of approximately 30%. With this in mind, we will recruit 240 participants at baseline.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
19/07/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
26/07/2017
Date of last data collection
Anticipated
31/12/2018
Actual
15/01/2019
Sample size
Target
240
Accrual to date
Final
125
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 293499 0
Government body
Name [1] 293499 0
National Health and Medical Research Council
Country [1] 293499 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] 292327 0
None
Name [1] 292327 0
None
Address [1] 292327 0
None
Country [1] 292327 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294941 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 294941 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] 294941 0
Australia
Date submitted for ethics approval [1] 294941 0
12/04/2016
Approval date [1] 294941 0
29/06/2016
Ethics approval number [1] 294941 0
2016/157

Summary
Brief summary
This project evaluates the efficacy of lifestyle management programs in adults to in reducing scores on questionnaire that evaluates risk profile for dementia. The interventions are the Body Brain Life - GP (BBL-GP) and Lifestyle Modification Program (LMP). There will also be an Active control group which receives email informatio
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65574 0
Prof Kaarin J Anstey
Address 65574 0
Centre for Research on Ageing, Health and Wellbeing
Building 54
Mills Road
The Australian National University
Canberra 2601
ACT
Country 65574 0
Australia
Phone 65574 0
+61 2 6125 8410
Fax 65574 0
Email 65574 0
kaarin.anstey@anu.edu.au
Contact person for public queries
Name 65575 0
Dr Sarang Kim
Address 65575 0
Centre for Research on Ageing, Health and Wellbeing
Building 54
Mills Road
The Australian National University
Canberra 2601
ACT
Country 65575 0
Australia
Phone 65575 0
+61 2 6125 0713
Fax 65575 0
Email 65575 0
sarang.kim@anu.edu.au
Contact person for scientific queries
Name 65576 0
Prof Kaarin J Anstey
Address 65576 0
Centre for Research on Ageing, Health and Wellbeing
Building 54
Mills Road
The Australian National University
Canberra 2601
ACT
Country 65576 0
Australia
Phone 65576 0
+61 2 6125 8410
Fax 65576 0
Email 65576 0
kaarin.anstey@anu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be available as stated in the participant information sheet.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3521Study protocolKim S, McMaster M, Torres S, et al Protocol for a pragmatic randomised controlled trial of Body Brain Life—General Practice and a Lifestyle Modification Programme to decrease dementia risk exposure in a primary care setting BMJ Open 2018;8:e019329. doi: 10.1136/bmjopen-2017-019329https://bmjopen.bmj.com/content/8/3/e019329 



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn internet-based intervention augmented with a diet and physical activity consultation to decrease the risk of dementia in at-risk adults in a primary care setting: Pragmatic randomized controlled trial.2020https://dx.doi.org/10.2196/19431
N.B. These documents automatically identified may not have been verified by the study sponsor.