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Trial registered on ANZCTR


Registration number
ACTRN12622000351718p
Ethics application status
Not yet submitted
Date submitted
13/01/2022
Date registered
25/02/2022
Date last updated
25/02/2022
Date data sharing statement initially provided
25/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
HABIT (Harnessing Automatic Behaviours Intervention Trial): A habits-based pilot behaviour change intervention to increase physical activity in people with mild cognitive impairment or subjective cognitive decline.
Scientific title
HABIT (Harnessing Automatic Behaviours Intervention Trial): A habits-based pilot behaviour change intervention to increase physical activity in people with mild cognitive impairment or subjective cognitive decline.
Secondary ID [1] 306201 0
Nil Known
Universal Trial Number (UTN)
U1111-1273-2279
Trial acronym
HABIT-MCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment (MCI) 324906 0
Subjective cognitive decline (SCD) 324907 0
Risk of dementia 324908 0
Cognitive Decline 324909 0
Risk of Alzheimer’s Disease 324910 0
Condition category
Condition code
Neurological 322344 322344 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical activity behaviour change intervention based on habits.

For older people experiencing decline to their memory and thinking skills, such as those with mild cognitive impairment (MCI) or subjective cognitive decline (SCD), keeping physically active is important to maintain brain health and reduce risk of dementia. Despite this, over 80% of older Australians do not do enough physical activity in their daily lives. To date, interventions to help people increase their physical activity levels have been social cognitive in their approach, and involved setting goals, planning and self-monitoring, which are challenging for people with thinking and memory difficulties. Recent research suggests that automatic, every-day habits play an important role in maintaining physical activity levels over the long-term. The current project aims to assess the feasibility and acceptability of a habits-based behaviour change intervention to help people with MCI or SCD increase their regular physical activity engagement.

This pilot project has two arms, the ‘Remote Intervention’, and the ‘In-Person Intervention’. The sample will be 20 older adults (65 years and older) with mild cognitive impairment (MCI) or subjective cognitive decline (SCD), who are undertaking the study. On completion of screening and written informed consent, participants will be randomised to either the remote or in person groups stratified for gender. The randomisation will be completed by a researcher utilizing an online random number generator (randomizer.org).


and will both undertake ‘Baseline Assessments’, ‘Education Workshop’, ‘Physiologist Interview’, access to Apple Watches, and on-going telephone support throughout the intervention.

A baseline assessment consisting of questionnaires assessing multiple cognitive functions will be administered online through the research application following the screening process for remote participants, and in person at Neuroscience Research Australia (NeuRA) for in-person participants. The questionnaires will become available again after 12 weeks of the intervention period (FU1) and again after another 12 weeks of the no-intervention period (FU2), either via the research application or in person at NeuRA. Participants will receive reminders on their phone through the Apple Watch research application to complete these assessments at those times. If they do not complete an assessment, they will receive a follow up email as a reminder, and failing that, the research assistant will call them to find out the reason and if they need help. Each assessment (Baseline, FU1, FU2) should take 1 hour, and will be monitored by the research team during their completion.

Participants will attend a 1.5-hour Education Workshop (either via video-conference or in person at Neuroscience Research Australia). The Education Workshop will cover a multitude of topics including: Importance of Physical Activity, How habits form and how they change, A habits-based approach to physical activity, What is an action plan, What is a coping plan, and How to set up Apple Watches.
The workshop will be run by principle investigator Dr Sophie Andrews. It will be interactive, allowing for questions and group discussion. There will be 5 participants involved in each workshop.

Following the workshop, all participants will have a 1.5-hour individual interview with a physiologist either in person at their home, or online via video conference. The interview will commence within one week following the workshop. During this interview they will discuss current physical activity, physical activity goals, and current enablers and barriers. The physiologist will then identify potential existing cues to link with a physical activity, a physical activity to incorporate into a longer physical activity or/and a “mini” activity for days when the participant has experienced barriers. They will set up the cue, response, reward relationship and prospective reminders (e.g., have this recorded on paper for the fridge or noticeboard). The physiologist will also confirm that participants have set up their Apple Watch correctly and know how to use it. The aim for participants will be for daily physical activity exercises cued by individual daily habits of 150 minutes of moderate intensity aerobic physical activity or 90 minutes of vigorous intensity exercise per week. The exercise we will be aiming to prescribe is walking. The duration of the exercise regime will be 12 weeks following the interview.

All participants will be asked to wear apple watches with a downloaded apple research application for daily prompts and questions regarding mood, stress levels, and if they did the physical activity habit each day. Adherence to the habit-based physical exercise plan will thus be monitored through objective measures (e.g., heart-rate changes, movement) and participant responses recorded through the watch. Weekly reports of Apple Watch statistics will be monitored including movement, HR- resting hr vs active – minutes in mod-vigorous activity each day, steps, calories burnt, active calories in activity and potentially GPS data location. If signs of lack of improvement or waning effectiveness, follow up calls will be made by research assistants to check in. Apple watches will be sent in mail after the Baseline assessment in time for the education workshop and exercise physiologist within a few days of each other. Participants will hold the watch for 12 weeks, then send back at Follow up 1. They will then be sent it 1 week before Follow up 2, where they will again return it. All postage will be paid for by NeuRA. We will aim for participants to wear the watch continuously at all times of the day.
For in-person intervention: Apple watches will be handed out at baseline assessments in person, left with participants for 12 weeks, then returned in person for the Follow up 1. They will then be mailed to participants one week before Follow up 2, where they will return it again in person.

All participants will receive telephone support from our research team at the following time-courses:
Weeks 1-4: Once a week telephone call for reflection on habit success, check in and support
Weeks 4-8: Fortnightly telephone check in and support
Week 12: Final call for check in and support
Support calls will generally last 10 minutes as a quick check in to make sure participants are not having any problems with the intervention, and to offer problem solving solutions to any barriers participants might be facing.

Physical activity intervention is planned to be personalised for each participant as it is based on their daily habits. As individuals with cognitive decline use more habit-based approaches to thinking and acting, by using habits to cue physical activity we hope to improve their weekly physical exercise. Thus, through at home visits and calls, we aim to set up individualised cues for physical activities at the beginning of the intervention, and leave participants to continue them each week for 12 weeks.
Cues can be related to a time, situation, or even an emotion (e.g., I feel stressed so I eat fast food). We will aim for cues that participants already do regularly (daily or a few times a week) as they rely less on memory
Examples of cues:
• Getting up in the morning
• Having your first cup of coffee
• Going to the shops
• Getting home from work
• Watching the nightly news
• Doing teeth before bed
• Calling your daughter for a regular check in

Intervention code [1] 322603 0
Prevention
Intervention code [2] 322604 0
Lifestyle
Intervention code [3] 322605 0
Behaviour
Comparator / control treatment
'The In-Person intervention' group is the comparator. We wish to test the efficacy of remote intervention against in-person in order to allow for a larger study which can recruit participants from all over Australia.
Control group
Active

Outcomes
Primary outcome [1] 330105 0
Recruitment and completion rates (number enrolled, number of withdrawals, completion rate)
This will be assessed as completed by two outcomes:
1: If they answer at least 50% of the daily responses on the application.
2: If they complete the follow up assessment FU1
Timepoint [1] 330105 0
24 weeks post 'Physiologist Interview'
Primary outcome [2] 330106 0
Participant safety (number and severity of adverse events).
Adverse events will be defined by any unfavorable or unintended sign, symptom or diagnosis associated with the study which may or may not be related to the intervention (e.g. fall, injury or change in medical status). In the current study, study related adverse events could be physical injuries from exercise uptake or psychological stress from cognitive testing, exercise, fatigue etc.
Adverse events will be recorded and categorised according to the Common Terminology Criteria for Adverse Events (CTCAE5). These will be recorded through weekly questionnaires that participants fill out with a yes/no response followed by an open response questionnaire to detail the event if one has occurred.
Timepoint [2] 330106 0
24 weeks post 'Physiologist Interview'. This will be assessed continuously throughout the course of the 24 week period post interview.
Primary outcome [3] 330107 0
Program compliance (agreed versus actual physical activity completed).
Participants will be assessed as having complied with the program if they have completed at least 50% of the planned exercise over the coarse of the 12 weeks following the interview.
This will be recorded via the Apple Research application where participants indicate if they have completed their exercise for that day, each day.
Timepoint [3] 330107 0
24 weeks post 'Physiologist Interview'
Secondary outcome [1] 404905 0
Change in objective weekly physical activity recorded as active heart rate & steps on Apple Research Application from Apple Watches
Timepoint [1] 404905 0
24 weeks post 'Physiologist Interview'
Secondary outcome [2] 404906 0
Change in physical activity habit strength as recorded by SRBAI
Timepoint [2] 404906 0
24 weeks post "Physiologist Interview'
Secondary outcome [3] 404907 0
Change in cognitive function as assessed by MoCA
Timepoint [3] 404907 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview'
Secondary outcome [4] 404908 0
Change in physical function as assessed by Falls efficacy scale international
Timepoint [4] 404908 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [5] 404909 0
Change in psychological function as assessed by the Depression, Anxiety and Stress Scale-21
Timepoint [5] 404909 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [6] 406147 0
Change in cognitive function as assessed by Symbol Digit Modalities Test
Timepoint [6] 406147 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [7] 406148 0
Change in cognitive function as assessed by Trails A & B
Timepoint [7] 406148 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [8] 406149 0
Change in cognitive function as assessed by Hopkins Verbal Learning Test
Timepoint [8] 406149 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [9] 406150 0
Change in physical function as assessed by Self-efficacy for Exercise Scale
Timepoint [9] 406150 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [10] 406151 0
Change in physical function as assessed by Incidental and Planned Exercise Questionnaire
Timepoint [10] 406151 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [11] 406152 0
Change in psychological function as assessed by Wellbeing COMPAS-W scale
Timepoint [11] 406152 0
Baseline test Day 0
12 weeks post 'Physiologist Interview'
24 weeks post 'Physiologist Interview
Secondary outcome [12] 406153 0
Change in mood as recorded by Apple Research Application from daily mood recordings.
Timepoint [12] 406153 0
Continuously from baseline to Follow Up 2

Eligibility
Key inclusion criteria
1. 65 years of age and older
2. Meet criteria for MCI or SCD
3. Completing less than the recommended physical activity levels for people aged 65 and over as measured by IPEQ responses, and responses to questions on resistance training and balance activities. I.e. <150 minutes of moderate and/or 75 minutes vigorous exercise per week; OR progressive resistance training <2 days per week; OR nil balance activities.
4. Be deemed safe to exercise using Adult Pre-Exercise Screening Tool (Stage 1). If deemed at risk by the tool, persons must seek approval to exercise from their GP or other health professional before participating.
5. Live in Sydney
6. Safe to undertake physical activity
7. Own an iPhone
8. Not currently participating in a similar research or medical intervention targeting increased physical activity.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Under the age of 65 years as we are targeting the elderly population because they are most at risk for MCI or SCD and low weekly physical activity
2. Physically active (>50 mins of moderate/vigorous PA per week) because our aim to increase physically activity for those who are not meeting recommended guidelines for weekly activity.
3. Do no own an iPhone. This is because we are implementing this initial study with apple watches. If this study leads to a larger randomised control trial, we will open its availability to android users too.

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)
Allocation will be concealed via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Feasibility/Acceptability pilot study, sample size has not been statistically calculated
Descriptive statistics to evaluate primary outcomes (e.g. 80% uptake)
Secondary outcomes will be using appropriate t-tests and ANOVA to evaluate pre-post changes from baseline to post intervention follow up time-points, looking for changes that may signal initial efficacy of intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2022
Actual
Date of last participant enrolment
Anticipated
10/07/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 310547 0
Charities/Societies/Foundations
Name [1] 310547 0
Dementia Australia Research Foundation
Country [1] 310547 0
Australia
Funding source category [2] 310548 0
Charities/Societies/Foundations
Name [2] 310548 0
Dementia Centre for Research Collaboration
Country [2] 310548 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
School of Psychology
University of New South Wales
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 311718 0
Other
Name [1] 311718 0
Neuroscience Research Australia (NeuRA)
Address [1] 311718 0
Margarete Ainsworth Building
139 Barker Street
Randwick, NSW 2031
Country [1] 311718 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310160 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 310160 0
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Ethics committee country [1] 310160 0
Australia
Date submitted for ethics approval [1] 310160 0
28/02/2022
Approval date [1] 310160 0
Ethics approval number [1] 310160 0

Summary
Brief summary
This project aims to investigate the feasibility of a habits based physical intervention (Harnessing Automatic Behaviours Intervention Trial (HABIT)) for elderly participants with mild cognitive impairment or subjective cognitive decline. We hypothesize that the HABIT intervention will be acceptable for participants, feasible, and efficacious, resulting in increased physical activity levels for participants during the intervention, and maintenance of those changes over 12 weeks following the completion of the intervention.
The intervention will include an education workshop on the importance of physical exercise, how habits work and how habits can be utilized to increase physical activity uptake. This will be followed by an interview with a physiologist who will tailor the habit-based approach to each participant and set clear individualized exercise goals.
Participants will receive apple watches for the duration of the intervention. The HABIT intervention will be evaluated against baseline verse follow-up rates of movement and heart rates changes tracked by the watches, along with participant reports of habit uptake, recruitment and completion rates (number enrolled, number of withdrawals, completion rate), participant safety (number and severity of adverse events) and program compliance (agreed versus actual physical activity completed).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116698 0
Dr Sophie Andrews
Address 116698 0
NeuRA
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Country 116698 0
Australia
Phone 116698 0
+610293991076
Fax 116698 0
Email 116698 0
s.andrews@neura.edu.au
Contact person for public queries
Name 116699 0
Dr Sophie Andrews
Address 116699 0
NeuRA
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Country 116699 0
Australia
Phone 116699 0
+610293991076
Fax 116699 0
Email 116699 0
s.andrews@neura.edu.au
Contact person for scientific queries
Name 116700 0
Dr Sophie Andrews
Address 116700 0
NeuRA
Margarete Ainsworth Building
139 Barker Street
Randwick NSW 2031
Country 116700 0
Australia
Phone 116700 0
+610293991076
Fax 116700 0
Email 116700 0
s.andrews@neura.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
As this is a feasibility study, we do not plan to share the data until we run a larger study with higher number of participants.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.