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Trial registered on ANZCTR


Trial ID
ACTRN12614001133628
Ethics application status
Approved
Date submitted
16/09/2014
Date registered
24/10/2014
Date last updated
9/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Lifestyle Intervention in Independent Living Aged Care
Scientific title
A randomised controlled study investigating the effects of diet (Mediterranean) and exercise (Aerobic) on memory, attention and other mental functions (Cognition) in a population aged 60 to 90 years of age living independently in Aged Care.
Secondary ID [1] 285309 0
None
Universal Trial Number (UTN)
U1111-1161-5364
Trial acronym
LIILAC (Lifestyle Intervention Independent Living Aged Care) Trial.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influence of diet change on cognition, mood and wellness 293015 0
Influence of diet change on blood biomarkers and cardiovascular health 293016 0
Influence of exercise change on cognition, mood and wellness 293110 0
Influence of exercise change on blood biomarkers and cardiovascular health 293111 0
Condition category
Condition code
Diet and Nutrition 293290 293290 0 0
Other diet and nutrition disorders
Cardiovascular 293291 293291 0 0
Other cardiovascular diseases
Mental Health 293292 293292 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a 6 month trial with ethical approval for future follow-up assessments over the longer term. The present trial will consist of 208 persons 60-90 years of age, living independently or supported accommodation within an aged care facility. Participants will be randomly allocated to one of four conditions:
Group 1 : Diet change to reflect a greater adherence to a Mediterranean diet
Group 2 : Exercise change to walk up to 30 minutes every second day
Group 3 : Combined diet and exercise change
Group 4 : Control group with no diet or exercise change

Participants will be randomly allocated to one of three interventions or to a control group with no lifestyle change.

Diet: The diet has been created by a dietician and clearly outlined in a healthier living booklet that the dietician has prepared for this trial. The administration of the diet will be by the participants.Those allocated to the diet change group will be required to score their diet in relation to a Mediterranean diet sheet and achieve at least an 85% adherence to the diet. Instruction on how to self assess the diet sheets and further internal programs of guidance with the participants will be given to participants to inform them of food choices via a specifically designed Mediterranean Healthier living diet recipe booklet. Participants will cook for themselves and be issued with recipes and meal ideas. Each person in the diet change group will be allocated 6 X 750ml bottles of premium extra virgin olive oil for the study ( allowing for an average usage of 46ml/day). An ongoing interaction with the participants will take place at 6 weeks (10-20 min telephone call)after the initiation of the trial by a member of the research team and then again at the 3 month (20-30 min face-to-face discussion) intervention and then again at 4.5 months ( 10-20 min telephone call) to ensure their adherence to the diet guide and also to ensure their enthusiasm and participation is maintained.
Those allocated to the exercise group will be required to walk 35 to 40 mins four to five days per week as their aerobic exercise. An ongoing interaction with the participants will take place at 6 weeks after the initiation of the trial by a member of the research team and then again at the 3 month intervention and then again at 4.5 months to ensure their maintaining the walking programme and also to ensure their enthusiasm and participation is maintained.
Walking does not require supervision or training. A guidance document prepared will be given to the participants with a pedometer to measure steps and distance covered during the walk.
Combined exercise and diet: Participants allocated to the exercise and diet change group will be required to walk 35 to 40 mins four to five days per week and will follow the procedure outlined in the diet condition i.e. achieve at least an 85% adherence to the Mediterranean diet. Each person in this group will also be allocated 6 X 750ml bottles of premium extra virgin olive oil for the study.An ongoing interaction with the participants will take place at 6 weeks after the initiation of the trial by a member of the research team and then again at the 3 month intervention and then again at 4.5 months to ensure their adherence to the diet guide and walking program to ensure their enthusiasm and participation is maintained.
The non intervention group will also receive ongoing interaction at 6 weeks after the initiation of the trial by a member of the research team and then again at the 3 month intervention and then again at 4.5 months to ensure their enthusiasm and participation is maintained.


Intervention code [1] 290219 0
Lifestyle
Intervention code [2] 290220 0
Behaviour
Comparator / control treatment
The comparator/control group will be tested without any intervention similarly to the other three allocated groups. The participants who volunteer will be residents at the same independent living facilities will be tested at the same time points as the intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 293134 0
Cognitive performance:
Swinburne University Computerised Cognitive Assessment Battery (SUCCAB). The SUCCAB consists of computerised measures of Simple Reaction Time, Complex Reaction Time, Immediate Recognition Memory, Stroop Colour-Word, Spatial Working Memory, Episodic Memory (contextual) and Delayed Recognition Memory
Timepoint [1] 293134 0
Assessment will take place at Baseline and 6 months.
Secondary outcome [1] 310426 0
Cardiovascular health:
Blood pressure and Arterial Stiffness and Aortic Blood pressure
This will be measured by using a SphygmoCor Xcel system. The SphygmoCor XCEL PWA device provides measurement Central Aortic Blood Pressure and Augmentation index in 60 seconds. A blood pressure cuff is placed on the patients arm, over the brachial artery. The SphygmoCor XCEL system, , takes the patients brachial systolic and diastolic pressure, and then captures the patient’s brachial waveform. The brachial waveform is then analyzed by the SphygmoCor Brachial GTF to provide a Central aortic waveform, and Central Blood pressure measurements such as Central Aortic Systolic BP, Central Pulse pressure (Pulse Wave Analysis) and Augmentation index are also displayed.
Pulse wave velocity will also be derived, using a femoral cuff to capture the femoral waveform and tonometer pressure sensor to capture the carotid waveform.
Timepoint [1] 310426 0
Baseline and 6 months post intervention commencement.
Secondary outcome [2] 310427 0
Mood and wellness: Profile of Mood states (POMS), The Depression, Anxiety and Stress Scale (DASS), General Health Questionnaire (GHQ-28) and Perceived Wellness Survey.
Sleep Assessment Pittsburg Sleep Qulity Index.
Timepoint [2] 310427 0
Baseline and 3 month post intervention commencement and 6 months post intervention commencement.
Secondary outcome [3] 310428 0
Exercise assessment: The 6 Minute Walk Test and Borg Assessment
Timepoint [3] 310428 0
Baseline and 6 months post intervention commencement.
Secondary outcome [4] 310454 0
Blood biomarkers:
Chol & Trigs, LFT, Glucose, Urea, CRP,Vitamin B12 & Red Cell Folate
Vitamin D,Vitamin B6,Homocysteine,HbA1c,IgF-1 (Somatomedin C)
and BDNF (Brain Derived Neurotrophic Factor)



Timepoint [4] 310454 0
Baseline and 6 months post intervention commencement.
Secondary outcome [5] 310455 0
Diet : Mediterranean Diet scale and Food frequency. The Cancer Council Food Frequency scale will be used to record dietary information and scored to determine adherence to the Mediterranean diet.

Timepoint [5] 310455 0
Baseline and 6 months post intervention commencement.
Secondary outcome [6] 310456 0
Secondary cognitive measures : assessment of crystallised intelligence. This will be assessed by the administration of the Wechsler Abbreviated Scale of Intelligence (WASI)
Timepoint [6] 310456 0
Baseline and 6 months post intervention commencement.

Eligibility
Key inclusion criteria
Currently living independently or supported accommodation
Ability to walk and be ambulatory for at least 30 mins
Free from major physical ailments
Willing to provide blood samples
Minimum age
60 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cognitive impairment as defined as a score below 24 on the MMSE.(Mini Mental State Examination)
Clinical diagnosis of depression, or score of 8 or above on the long form Geriatric Depression Scale.
Diagnosis of dementia or Alzheimer’s disease
History of stroke or head trauma
Colour Blindness

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)
After agreements are in place with independent living aged care facilities, posters and bulletins will be used to invite residents to an information session. As a result of the session, information will be provided to the potential participant and an initial eligibility screening will be performed.Participants will initially be screened to assess eligibility against the inclusion and exclusion criteria. Potential participants will also be administered the MMSE to check for potential cognitive impairment, one of the exclusion criteria. Potential participants will also be administered the Geriatric Depression Scale to determine if any depressive symptoms are present, also part of the exclusion criteria. Participants will be requested to have their consent forms to be signed by their medical practitioner to ensure their health status will allow them to participate as well as informing their doctor of the trial. Once the signed consent forms are received, a participant is centrally randomised to a group by a computer generated randomisation and the study will be initiated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to treatment groups will be determined by a computer number random generator.Eligible, recruited participants will be assigned a participant number. The randomisation order that has been assigned to the participant’s number will be the allocated treatment for that individual.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Using Cohen’s effect size criteria, this represents a medium effect size (Cohen, 1992). Power analysis was conducted using GPower 3.1.3 to determine the sample size required for a four armed intervention (exercise change only, diet change only, exercise and diet change, no change) using an analysis of variance (ANOVA) design. It was indicated that a total sample of 180 participants would be required to detect a medium effect size (f=.25), at a power level of 0.8 and a significance level of p<.05. In order to allow for a 15% drop out from the trial, a total sample of 208 participants will be recruited for this trial, with 52 individuals randomised to each arm of the study.

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)
VIC

Funding & Sponsors
Funding source category [1] 289935 0
University
Name [1] 289935 0
Swinburne University of Technology

Resources and Student Funds and Department allocations
Address [1] 289935 0
Burwood Road Hawthorn Victoria 3122
Country [1] 289935 0
Australia
Funding source category [2] 289936 0
Commercial sector/Industry
Name [2] 289936 0
Cobram Estate (In kind donation of Premium Extra Virgin Olive Oil)
Address [2] 289936 0
Unit 14, 75 Lorimer Street Southbank Victoria 3006
Country [2] 289936 0
Australia
Funding source category [3] 289937 0
Commercial sector/Industry
Name [3] 289937 0
HealthCare 2 you (In kind development of Mediterranean-Healthier Diet Recipe Booklet)
Address [3] 289937 0
146 Hawthorn Road, Caulfield North VIC 3161
Country [3] 289937 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
The Centre for Human Psychopharmacology
Burwood Road Hawthorn
PO Box 218 Victoria 3122
Country
Australia
Secondary sponsor category [1] 288626 0
None
Name [1] 288626 0
Address [1] 288626 0
Country [1] 288626 0
Other collaborator category [1] 278154 0
Commercial sector/Industry
Name [1] 278154 0
Australian Unity Ltd,
Address [1] 278154 0
114 Albert Road, South Melbourne, Victoria 3205
Country [1] 278154 0
Australia
Other collaborator category [2] 278394 0
Charities/Societies/Foundations
Name [2] 278394 0
Churches of Christ Queensland
Address [2] 278394 0
41 Brookfield Road
Kenmore Qld 4069
Country [2] 278394 0
Australia
Other collaborator category [3] 278395 0
Charities/Societies/Foundations
Name [3] 278395 0
Baptcare Ltd
Address [3] 278395 0
1193 Toorak Road
Camberwell Victoria 3124
Country [3] 278395 0
Australia
Other collaborator category [4] 278477 0
Charities/Societies/Foundations
Name [4] 278477 0
Catholic Homes Villa Maria
Address [4] 278477 0
2a Domville Street
Hawthorn Vic 3122
Country [4] 278477 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291652 0
Swinburne University Human Research Ethics Commitee
Ethics committee address [1] 291652 0
Burwood Road Hawthorn Victoria 3123
Ethics committee country [1] 291652 0
Australia
Date submitted for ethics approval [1] 291652 0
Approval date [1] 291652 0
18/12/2013
Ethics approval number [1] 291652 0
SUHREC 2013/057

Summary
Brief summary
The aim of this project is to investigate the effects of a 6 month lifestyle intervention, based on a diet and exercise program, on cognitive function, mood general health and well-being. The intervention will be conducted in those aged 60-90 years who live independently in age care accommodation.
We have published data showing that it is possible to improve mood and cognitive parameters in younger individuals with as little as 10 days adherence to a Mediterranean diet. The six month intervention period represents maintenance over a longer period of time important for longer term adoption of a change of lifestyle.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51322 0
A/Prof Andrew Pipingas
Address 51322 0
Head of Neurocognitive Ageing Research, Centre for Human Psychopharmacology (CHP)

Faculty of Health, Arts & Design
Swinburne University of Technology
P.O. Box 218
Hawthorn, Victoria 3122
Country 51322 0
Australia
Phone 51322 0
+61 3 9214 5215
Fax 51322 0
Email 51322 0
apipingas@swin.edu.au
Contact person for public queries
Name 51323 0
Mr Roy Hardman
Address 51323 0
Swinburne University of Technology
400B Burwood Road
Hawthorn Victoria 3123
Country 51323 0
Australia
Phone 51323 0
+61 3 9214 44566
Fax 51323 0
Email 51323 0
rhardman@swin.edu.au
Contact person for scientific queries
Name 51324 0
A/Prof Andrew Pipingas
Address 51324 0
Head of Neurocognitive Ageing Research, Centre for Human Psychopharmacology (CHP)

Faculty of Health, Arts & Design
Swinburne University of Technology
P.O. Box 218
Hawthorn, Victoria 3122
Country 51324 0
Australia
Phone 51324 0
+61 3 9214 5215
Fax 51324 0
Email 51324 0
apipingas@swin.edu.au