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Trial registered on ANZCTR


Registration number
ACTRN12616000720415
Ethics application status
Approved
Date submitted
12/05/2016
Date registered
31/05/2016
Date last updated
31/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cognitive Decline and Intensive Therapeutic Lifestyle Change (ITLC) – A Pilot Study
Scientific title
An uncontrolled pilot study of older adults with cognitive decline, investigating the feasibility of supported Intensive Therapeutic Lifestyle Change (ITLC) on cognitive decline over 1 year.
Secondary ID [1] 289201 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive decline 298752 0
Dementia 298753 0
Mild cognitive impairment 298754 0
Subjective cognitive impairment 298755 0
Condition category
Condition code
Neurological 298803 298803 0 0
Neurodegenerative diseases
Neurological 298805 298805 0 0
Dementias
Neurological 298806 298806 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a pilot study for a larger trial of the Complete Health Improvement Program (CHIP) as an intervention to slow cognitive decline.

Participants are invited to attend the CHIP lifestyle intervention which is an evidence-based Intensive Therapeutic Lifestyle Change program that targets chronic disease. The program is a group-based intervention and involves participants viewing together pre-recorded video presentations delivered by health professionals. Hence, the content of the intervention is standardised and therefore will be facilitated by non-health trained volunteers.

All participants in CHIP receive a pack consisting of a textbook with much of the video content, a workbook with questions on the session, and a cookbook. The kit also includes a pedometer and water-bottle.

The participants will participate in an intensive phase of the program (initial 2 months), followed up by monthly support sessions. During the intensive phase, the participants will attend 2-3 group sessions per week (for a total of 18 sessions in the 2 month period). Each session will be approximately 1.5 hours in duration and will be conducted in a local community hall.

The program outline for the intensive phase:
Session 1 - The Rise and Rise of Chronic Disease
Session 2 - Lifestyle is the Best Medicine
Session 3 - The Common Denominator of Chronic Disease - poor lifestyle habits
Session 4 - Optimal Lifestyle
Session 5 - Eat More, Weigh Less
Session 6 - Fibre, Your New Best Friend
Session 7 - Disarming Diabetes
Session 8 - The Heart of the Matter—Heart Healthy
Session 9 - Controlling Blood Pressure and Discovering Protein
Session 10 - Bone Health Essentials
Session 11 - Cancer Prevention
Session 12 - Understanding Your Results and Taking Action
Session 13 - Become What You Believe and Your DNA is Not Your Destiny - epigenetics
Session 14 - Practicing Forgiveness
Session 15 - Re-engineering Your Environment
Session 16 - Stress-relieving Strategies
Session 17 - Fix How You Feel
Session 18 - From Surviving to Thriving

After the intensive phase, the monthly support ClubCHIP sessions, will also be conducted in a group setting, but in the case that the participants cannot attend they will be contacted by a member of the research team by either telephone or email.


ClubCHIP meetings last 2 hours consisting of a 30 minute support group led by CHIP presenters, followed by a community meal (each attendee brings plant-based dishes). Most meetings feature a speaker on health related subjects. Speakers have included general practitioners, researchers, exercise physiologists, dieticians or members of the community with experience at lifestyle change but no related qualifications.

As a condition of participating in the study the participants with a diagnosis of dementia must have a “supporter” who is willing to undertake the CHIP intervention with them and assist them with the intervention and also to monitor, and report, adherence.

The CHIP intervention educates and empowers participants to eat more healthfully (with emphasis on a whole-food, plant-based diet), become more physically active (specifically through walking), and avoid substances including tobacco and alcohol. The program also covers content relating to stress management and behaviour change maintenance.

A comprehensive Health and Lifestyle survey is conducted at the beginning of the CHIP program. This self-reported survey includes items relating to the participants’ demographics, personal health history, medication usage and lifestyle habits (diet, physical activity, substance use, sleep, etc).

The Health and Lifestyle survey is administered in the form of a written document and shall be completed by the participant in a community hall with the assistance of their supporter when appropriate.

Adherence of study subjects will be monitored at the monthly support sessions by a modified version of the lifestyle section of the Health and Lifestyle survey and by pedometer readings. Participants will be followed for the 11 months until retesting takes place. Retesting will occur a year after baseline, making overall duration of the intervention 13 months.

As with all CHIP participants, study subjects are invited to other health promotion programs run by the CHIP team, these include cooking demonstrations, depression relief, supermarket tours and programs to improve mental and emotional wellbeing. Participation in these programs by subjects will be recorded and additional resources reported.

Cognitive decline is measured by the Audio Recorded Cognitive Screen (ARCS) and the severity and progression of dementia as measured by the Cambridge Behavioural Inventory revised form (CBI-R) completed by the supporter while the participant is completing the ARCS.

The ARCS involves the participant listening to recorded questions (through headphones) and writing answers in a printed workbook. The ARCS will be facilitated by a member of the research team in the community hall and requires approximately 35 minutes to complete.

Meanwhile the supporter is completing the CBI-R and the Supporter’s Questionnaire (approximately 15 minutes). The supporter’s questionnaire was designed specifically for this study, it documents the supporter’s experience of the progression of the participant’s dementia in all the domains of dementia (cognition, functional activities, mental changes, inappropriate behaviours and physical changes).

Cognitive decline, and the severity and progression of dementia will be the primary outcome for the full trial but only secondary for the pilot study.

Investigators will keep journals throughout the study, noting especially issues relating to recruitment, the instruments developed for the study, administration of instruments, coaching and adherence, and maintaining data integrity. The journals will be assessed at the end of the study, recruitment at the end of recruiting.
Intervention code [1] 294732 0
Lifestyle
Intervention code [2] 294827 0
Treatment: Other
Intervention code [3] 294828 0
Behaviour
Comparator / control treatment
No control group for pilot trial
Control group
Active

Outcomes
Primary outcome [1] 298279 0
Assess the feasibility of the program for people with cognitive impairment.
Assessed by interview, following the format of the CHIP feedback form, of participants and supporters.
Timepoint [1] 298279 0
2 months and 13 months
Primary outcome [2] 298404 0
Assess adherence to the program after the intensive phase by monitoring diet and physical activity.
Assessed by self-report using a modified Health and Lifestyle survey designed for this study and the 4-Leaf (diet) Survey.
Timepoint [2] 298404 0
Monthly from month 3 to 13 months.
Primary outcome [3] 298405 0
Assess the utility of the self-reported profile and adherence questionnaires developed for the study.
Assessed by analysing reported problems and feedback from journals kept by investigators throughout the study.
Timepoint [3] 298405 0
13 months.
Secondary outcome [1] 323733 0
Cognitive decline
Measured by the Audio Recorded Cognitive Screen (ARCS).
Timepoint [1] 323733 0
At baseline and 13 months
Secondary outcome [2] 323735 0
Progression and severity of dementia
Measured by the Cambridge Behavioural Inventory revised form (CBI-R)
Timepoint [2] 323735 0
At baseline and 13 months
Secondary outcome [3] 324280 0
Body Mass Index
Estimated with height using a stadiometer and weight using digital scales.
Timepoint [3] 324280 0
Baseline, 5 weeks and 13 months
Secondary outcome [4] 324281 0
Weight
Measured with digital scales
Timepoint [4] 324281 0
Baseline, 5 weeks and 13 months
Secondary outcome [5] 324282 0
Total LDL and HDL cholesterol, fasting plasma glucose
Blood taken and analysed by commercial pathology service
Timepoint [5] 324282 0
Baseline and 5 weeks
Secondary outcome [6] 324283 0
Seated Blood Pressure
Measured by registered nurse using automated sphygmomanometry
Timepoint [6] 324283 0
Baseline, 5 weeks and 13 months
Secondary outcome [7] 324284 0
Social engagement as a confounding factor
Self-reported in Health and Lifestyle Questionnaire
Timepoint [7] 324284 0
Baseline and 13 months
Secondary outcome [8] 324285 0
Depression, as a confounding factor
Measured by the Geriatric Depression Scale (GDS)
Timepoint [8] 324285 0
Baseline and 13 months
Secondary outcome [9] 324286 0
Effectiveness of recruiting techniques
Assessed from journals and numbers recruited at each recruiting session
Timepoint [9] 324286 0
At end of recruiting
Secondary outcome [10] 324287 0
Maintenance of data integrity
Assessed from journals
Timepoint [10] 324287 0
13 months

Eligibility
Key inclusion criteria
Free-living within the community with a recent (within the preceding year) diagnosis of dementia of any type, MCI or SCI.
Willing and able to provide written informed consent
Fluent in written and spoken English.
Participants in the intervention group must be willing to participate in the CHIP intervention, pay for the CHIP intervention ($400 for both participant and supporter) and be willing and able to implement the lifestyle changes advocated by the program.
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Advanced dementia
Diagnosis of dementia but not having a supporter

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The main purpose of the study is to assess the feasibility of a larger trial.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics only on outcome data.
Methodological issues will be assessed on findings during the study and reported.
Sample size calculation will be attempted if target number is achieved.

Recruitment
Recruitment status
Recruiting
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)
NSW
Recruitment postcode(s) [1] 13233 0
2264 - Morisset
Recruitment postcode(s) [2] 13234 0
2259 - Wyee
Recruitment postcode(s) [3] 13235 0
2265 - Cooranbong

Funding & Sponsors
Funding source category [1] 293578 0
Self funded/Unfunded
Name [1] 293578 0
Unfunded
Address [1] 293578 0
Unfunded
Country [1] 293578 0
Primary sponsor type
University
Name
Avondale College
Address
582 Freemans Dr, Cooranbong NSW 2265
Country
Australia
Secondary sponsor category [1] 292400 0
None
Name [1] 292400 0
None
Address [1] 292400 0
None
Country [1] 292400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295025 0
Avondale College Human Research Ethics Committee
Ethics committee address [1] 295025 0
Avondale College
582 Freemans Dr, Cooranbong NSW 2265
Ethics committee country [1] 295025 0
Australia
Date submitted for ethics approval [1] 295025 0
13/11/2015
Approval date [1] 295025 0
26/11/2015
Ethics approval number [1] 295025 0
2015:43

Summary
Brief summary
In Australia, 1800 new cases of dementia are diagnosed each week (Alzheimer's Australia, 2015). Despite the alarming prevalence of dementia no medications are available that reverse, or even slow the effects of the disease on the brain. This bleak outlook is only brightened by the likelihood that some dementia is preventable. Modifiable risk factors—including lifestyle practices such as smoking, exercise and a healthy diet—have recently been proposed to be responsible for 66% of all Alzheimer's, which is the most common form of dementia (Xu, Wei et al, 2015). In 2014, a large group of dementia experts asserted that if the population were to adopt a healthy lifestyle, 20% of dementia would be prevented (Yaffe, Kristine et al. 2014). Specifically, regular exercise and diets high in plant foods have been shown to reduce the risk of cognitive impairment (Ahlskog et al, 2011; Lourida et al. 2013).

The proposed full trial seeks to be the first to examine in a controlled fashion whether Intensive Therapeutic Lifestyle Change (ITLC), specifically in the form of a lifestyle intervention known as the Complete Health Improvement Program (CHIP), can affect the progression of Cognitive Decline in people with newly diagnosed dementia or mild cognitive impairment. The study will be conducted over a four-year period and will involve people with newly diagnosed dementia, or MCI, self-selecting to participate in an ITLC group (who will participate in a 2 month intensive CHIP intervention followed by monthly follow-up sessions). Cohort randomisation is proposed, the control group receiving care as usual.

The pilot study is to test the feasibility of conducting the larger study and assess issues of implementing ITLC with cognitively impaired individuals. ITLC, because of the “number and difficulty of behaviours required by those delivering and receiving the intervention” is a complex intervention according to the UK Medical Research Council guidance. Therefore this pilot study will specifically test the feasibility of recruitment techniques and the appropriateness and acceptability of the intervention (are numbers of people with cognitive decline and their supporters willing to change their lifestyle?), the feasibility of the logistics and timing of adherence and coaching methods, and retention rates in the 10 months after the intense intervention. The pilot will assess the utility of the ad hoc instruments used to measure adherence and the domains of dementia. Data integrity and handling will be assessed. Finally the quality of the results recorded by the researchers in the intended primary outcome of the full trial, the change in cognitive decline and behaviour, will be assessed by the geriatrician.

Because this is a pilot study with no control group and the number of participants is expected to be small, the results will be reported without analysis. Results will not be carried forward into the full study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65810 0
Dr Darren Morton
Address 65810 0
Avondale College
582 Freemans Dr,
Cooranbong NSW 2265
Country 65810 0
Australia
Phone 65810 0
+61 2 4980 2222 ext 161
Fax 65810 0
Email 65810 0
darren.morton@avondale.edu.au
Contact person for public queries
Name 65811 0
Mr Bruce Thompson
Address 65811 0
Avondale College
582 Freemans Dr,
Cooranbong NSW 2265
Country 65811 0
Australia
Phone 65811 0
+61 410 025 894
Fax 65811 0
Email 65811 0
s15171957@student.avondale.edu.au
Contact person for scientific queries
Name 65812 0
Dr Darren Morton
Address 65812 0
Avondale College
582 Freemans Dr,
Cooranbong NSW 2265
Country 65812 0
Australia
Phone 65812 0
+61 2 4980 2222 ext 161,
Fax 65812 0
Email 65812 0
darren.morton@avondale.edu.au

No information has been provided regarding IPD availability
Summary results
No Results