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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06291909




Registration number
NCT06291909
Ethics application status
Date submitted
18/02/2024
Date registered
4/03/2024
Date last updated
29/03/2024

Titles & IDs
Public title
Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia
Scientific title
Small Steps Towards Personalized Dementia Prevention: Implementation and Evaluation of a Personalized, Technology-assisted Physical Behaviour Intervention
Secondary ID [1] 0 0
205989
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 0 0
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Small Steps Program
Behaviour - Comparator Program

Placebo Comparator: Condensed Program Group - Identification of optimal time use with comparison to current time use. No research staff supported goal setting, provision of lifestyle information resources through website (no other website functionality available).

Experimental: Extended Program Group - Identification of optimal time use with comparison to current time use, complete access to the Small Steps digital interface, frequent one-on-one support from research staff, supported goal setting and behaviour change choices.


Behaviour: Small Steps Program
Participants in the intervention group will be given access to the Small Steps website. Small Steps website provides a visual representation of the participant's current use of time and allows for manipulation to demonstrate how small lifestyle changes may improve sleep and physical activity needs. The personal outcome goals selected by the participant will also feature on participant's dashboard within the Small Steps website as a reminder. Participants will be prompted through the first 12 weeks to add a new behaviour change each week and will receive support phone calls weekly. During the 12-week Maintenance Phase participants will be guided to maintain their new behaviour, with supportive phone calls being progressively reduced from fortnightly to monthly. At the completion of the 12 weeks, investigator support will be withdrawn. Maintenance of the new behaviour without support will then be assessed over 12 additional weeks in the Follow-Up phase.

Behaviour: Comparator Program
Participants will receive generic health advice only and it will not be individually tailored, nor will they receive weekly support phone calls during the first 12-weeks. Participants will receive no feedback or support in the Maintenance or Follow-Up phases.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participant logins onto the "Small Steps" website
Timepoint [1] 0 0
0-36 weeks
Primary outcome [2] 0 0
Number of participant check-ins on the "Small Steps" dashboard
Timepoint [2] 0 0
0-36 weeks
Primary outcome [3] 0 0
Number of participant behavioural change choices on the "Small Steps" website during the Introduction Phase. The greater number of choices indicates a greater engagement with the intervention and use of the website.
Timepoint [3] 0 0
0-12 weeks
Primary outcome [4] 0 0
Time participants spent on the "Small Steps" website
Timepoint [4] 0 0
0-36 weeks
Primary outcome [5] 0 0
Duration of each participant behavioural change choice during the Introductory Phase
Timepoint [5] 0 0
0-12 weeks
Primary outcome [6] 0 0
Holden's Simplified System Usability Scale
Timepoint [6] 0 0
12 and 24 weeks
Primary outcome [7] 0 0
Health Care Climate Questionnaire
Timepoint [7] 0 0
12 and 24 weeks
Primary outcome [8] 0 0
Behavioural Automaticity Questionnaire
Timepoint [8] 0 0
0, 12, 24 and 36 weeks
Primary outcome [9] 0 0
(Behavioural Regulation in Exercise Questionnaire
Timepoint [9] 0 0
0, 12, 24 and 36 weeks
Primary outcome [10] 0 0
Self-efficacy and Intention Questionnaire
Timepoint [10] 0 0
0, 12, 24 and 36 weeks
Primary outcome [11] 0 0
Perceived Competence Scale
Timepoint [11] 0 0
0, 12, 24 and 36 weeks
Primary outcome [12] 0 0
Exit interview
Timepoint [12] 0 0
36 weeks
Primary outcome [13] 0 0
Daily activity
Timepoint [13] 0 0
0, 12, 24 and 36 weeks
Primary outcome [14] 0 0
Sleep quality
Timepoint [14] 0 0
0, 12, 24 and 36 weeks
Primary outcome [15] 0 0
Sleep Hygiene
Timepoint [15] 0 0
0, 12, 24 and 36 weeks
Primary outcome [16] 0 0
Sleep quantity
Timepoint [16] 0 0
0, 12, 24 and 36 weeks
Secondary outcome [1] 0 0
Addenbrooke's Cognitive Exam III
Timepoint [1] 0 0
0, 12, 24 and 36 weeks
Secondary outcome [2] 0 0
Trail Making Test
Timepoint [2] 0 0
0, 12, 24 and 36 weeks
Secondary outcome [3] 0 0
Digit Span Test
Timepoint [3] 0 0
0, 12, 24 and 36 weeks

Eligibility
Key inclusion criteria
- Aged 65 years or older

- Ambulatory and community dwelling

- Fluent in the English Language (required for cognitive assessments)

- Resident of Onkaparinga Council

- Access and competency in using technology (i.e., phone, tablet, computer)

- Not meeting the Australian physical activity guidelines - 150 minutes per week of
moderate intensity physical activity (self-report)

- Deemed safe to participate in physical activity (ESSA APSS stage 1) or clearance from
health professional
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Scores below the mild cognitive impairment (MCI) cut-off (<13/22) on the Montreal
Cognitive Assessment-Blind (MoCA-B) or a current diagnosis of dementia

- Self-reported meeting the Australian physical activity guidelines

- Major neurological or psychiatric diagnosis

- Known intellectual disability

- Major physical disability

- Lack of English fluency

- Involved in another intervention trial involving physical activity, brain training,
and/or diet

- Have vision problems which may prevent them from reading a computer and/or phone
screen

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)
Methods used to generate the sequence in which subjects will be randomised (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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
3/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
5001 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of South Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomised controlled study aiming to evaluate the implementation of a website
('Small Steps') to support the modification of participants' time-use behaviour to reduce the
risk factors for dementia. 'Small Steps' website provides the tools for this with a visual
representation of the participant's current use of time and allowing manipulation to
demonstrate how small lifestyle changes may improve and meet sleep and physical activity
needs. Participants will be assisted to make changes to current behaviours with the aim to
reduce the time they spend sitting (sedentary behaviour), increase physical activity, and
improve sleep duration and quality.

Participants (aged 65 or older) will be randomly allocated to one of two groups, the
'Extended Program' (intervention) group or the 'Condensed Program' (control) group.

There are 3 phases (Introductory, Maintenance and Follow-Up; each 12-weeks long) to this
program and in total the program is 36-weeks long. Participants will use a tailored website
to help support them in making progressive changes over the first 12 weeks. They will then
try to maintain these behaviour changes for as long as possible. There will be in-person
health testing during each phase and information about sleep habits, sleep quality, and
motivation will be assessed using online surveys. Physical activity levels and sleep duration
will also be assessed.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06291909
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ashleigh Smith, PhD
Address 0 0
University of South Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Catherine Yandell, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 8 83022109
Fax 0 0
Email 0 0
catherine.yandell@unisa.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06291909