DementiaNCT06291909
Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia
A study testing Small Steps Program and Comparator Program in people with Dementia and Alzheimer Disease, run by University of South Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Small Steps Program and Comparator Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Apr 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 years or older
- Ambulatory and community dwelling
- Fluent in the English Language (required for cognitive assessments)
- Resident of City of Onkaparinga Council, Marion City Council, City of Port Adelaide and Enfield, City of Playford, City of Salisbury, City of Tea Tree Gully
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
University of South Australia
Adelaide, South Australia, 5001
About this study
Official title: Small Steps Towards Personalized Dementia Prevention: Implementation and Evaluation of a Personalized, Technology-assisted Physical Behaviour Intervention
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.
Read the detailed description
The investigators have previously co-designed a personalised, technology-assisted physical activity intervention called 'Small Steps', which promotes positive behaviour changes to reduce dementia risk factors. The current study aims to implement and evaluate this intervention. The 'Small Steps' website provides the tools for facilitating changes in time-use behaviours 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. Rather than considering single time-use components as independent variables, including 24-hour time-use compositions in the same analytical model will allow the inevitable interplay between the individual components to be assessed.
Older adults most at risk of dementia (older population, low physical activity levels, lower socio-economic status areas) will be recruited. Participants will be assessed face-to-face by trained research staff at study Enrolment, and completion of the Introduction, Maintenance and Follow-Up Phases (each phase is 12 weeks long). The trial will involve comprehensive assessments including detailed demographics, anthropometry and time-use assessments.
The intervention will be modelled on our previously successful method of reducing sitting time in older adults and use recommendations of the optimal activity composition generated from a previous study (ACTIVate Study, Smith et al. BMJ Open 2022;12:e047888). Older adults will be able to work with research staff to co-create interventions that are individualised for their own needs based on individual preferences, constraints and lifestyle. It is hypothesised that the Small Steps intervention will be both more effective than generic health advice (control group) and effects will hold over time (to end of the Follow Up Phase).
Hypotheses: In older adults at risk of dementia, a Small Steps intervention compared to generic health advice will be feasible and associated with:
- increased time spent in physical activity from Enrolment to end of the each phase, compared to generic health advice.
- improved cognitive functioning assessed by the Addenbrooke's Cognitive Exam.
- improved sleep quality as assessed by the Pittsburgh Sleep Quality questionnaire and Sleep Hygiene Index.
Aims:
- Assess the feasibility of a personalised technology assisted behavioural intervention to improve the 24-hour time use of older adults.
2.) Assess whether a personalised 24-hour time-use intervention increases physical activity and improves sleep behaviour.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Small Steps Program, Comparator Program
- Keywords
- physical activity, sleep, sedentary behavior, behavioral intervention, cognition, dementia
- Medical subject headings
- Dementia, Alzheimer Disease, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small Steps ProgramBehavioural
Also called Extended 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.
Comparator ProgramBehavioural
Also called Condensed 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.
| Study group | Role | What they receive |
|---|---|---|
| Condensed Program Group | Placebo comparator | 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). Receives: Behavioral: Comparator Program |
| Extended Program Group | Experimental | 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. Receives: Behavioral: Small Steps Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participant logins onto the "Small Steps" website
Analysis of the Small Steps website will be performed to provide the number of logins for each on participant with the 'Small Steps' website. A higher the number of logins, indicates greater engagement with the website.
Measured: 0-36 weeks
Number of participant check-ins on the "Small Steps" dashboard
Analysis of the Small Steps website will be performed to provide the number of check-ins for each on participant with the 'Small Steps' website. Participants are asked to check-in weekly at a minimum. A higher the number of logins, indicates greater engagement with the website.
Measured: 0-36 weeks
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.
Analysis of the Small Steps website will be performed to analyse the number of behavioural change choice each participant makes within the 'Small Steps' website. A higher the number of choices, indicates greater engagement with the intervention.
Measured: 0-12 weeks
Time participants spent on the "Small Steps" website
Analysis of the Small Steps website will be performed to analyse the time each participant spends on the 'Small Steps' website. This will be measured in minutes/login and total number of minutes. A greater number of minutes, indicates greater engagement with the intervention.
Measured: 0-36 weeks
Duration of each participant behavioural change choice during the Introductory Phase
The duration of each behavioural change the participants choose to make at each week. The duration will be measured in minutes/day for each new behavioural change choice.
Measured: 0-12 weeks
Holden's Simplified System Usability Scale
The intervention feasibility will be measured by Holden's Simplified System Usability Scale questionnaire, participant reported. The Holden's Simplified System Usability Scale is 10-item design, five-item agreement-based Likert scale, from Strongly agree (5) to Strongly disagree (1) with total scores ranging from 10- 50. It allows you to evaluate software, mobile devices, websites and applications. A higher score indicates greater usability.
Measured: 12 and 24 weeks
Health Care Climate Questionnaire
The intervention acceptability will be measured by the Health Care Climate Questionnaire (participant reported). This is a 6 item (shortened version) using a 7-point Likert-type scale, from Not At All True (1) to Very True (7). The total scores will range from 6 - 42 and a higher score indicates greater acceptability. The preamble and wording of each item will be altered, to better align with the Small Steps intervention and the role of the health professional.
Measured: 12 and 24 weeks
Behavioural Automaticity Questionnaire
The intervention acceptability feasibility will be measured by a Behavioural automaticity (Self-Report Behaviour Automaticity Index) questionnaire. Participants rate items (such as "Physical activity is something I do automatically") on a scale ranging from 1 (strongly disagree) to 7 (strongly agree). Participants will complete the measure in relation to four different behaviours; physical activity, sedentary behaviour, and good sleep practices with each of these 4 behaviours ranging in scores from 4-28. A higher score indicates greater automaticity for that behaviour.
Measured: 0, 12, 24 and 36 weeks
Self-efficacy and Intention Questionnaire
The intervention feasibility will be measured by self-efficacy and intention questionnaire (participant reported). Participants self-efficacy for physical activity will be captured through the self-efficacy for exercise scale. Intention to be physically active and perform positive sleep behaviours will each be assessed. Participants will respond on a 7-point Likert scale with options ranging from 1 (Strongly Disagree) to 7 (Strongly Agree). The total scores will range from 7- 14, with a higher score indicating greater feasibility of the intervention.
Measured: 0, 12, 24 and 36 weeks
Perceived Competence Scale
Participants' satisfaction of their psychological needs of competence will be assessed using the Perceived Competence Scale. This is a short 4-item questionnaire assessing participants' perceived competence to exercise. Participants respond to the 4-items using a 7-point Likert type scale, ranging from 1 (not at all true) to 7 (very true). The total scores will range from 4 - 28, with a higher score indicating greater participant confidence and feelings of competence.
Measured: 0, 12, 24 and 36 weeks
Exit interview
A single Semi-structured exit interview will elicit rich data on participant experiences, perceived burden, suggestions for improvement and barriers to feasibility.
Measured: 36 weeks
Daily activity
Continuous recording using a wrist-worn activity monitor (FitBit) with daily time-use derived from a 7-day average. Time spent in sedentary, light, moderate-to-vigorous and vigorous physical activity (min/day).
Measured: 0, 12, 24 and 36 weeks
Sleep quality
Self-reported sleep quality as measured by Pittsburgh Sleep Quality Index (PSQI). The PSQI is 19-item self-report index to assess sleep quality. The questionnaire consists of a combination of Likert type and open-ended questions (later converted to scaled scores using provided guidelines). Scoring provides an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: 0, 12, 24 and 36 weeks
Sleep Hygiene
Self-reported sleep quality as measured by Sleep Hygiene Index (SHI). The SHI is a 13-item self-report index designed from the ICSD to assess the presence of sleep hygiene behaviours. Each of the item is rated on a five-point Likert scale (ranging from 0 [never] to 4 [always]). The total scores ranged from 0 to 52, with higher scores indicating poorer sleep hygiene status.
Measured: 0, 12, 24 and 36 weeks
Sleep quantity
Continuous recording using a wrist-worn activity monitor (FitBit) with daily time-use derived from a 7-day average with sleep time measured in minutes per day.
Measured: 0, 12, 24 and 36 weeks
Secondary outcomes (5)
Addenbrooke's Cognitive Exam III
Scores for Addenbrooke's Cognitive Exam III (ACE-III). This consists of 19 activities which test five cognitive domains: attention (score 0-18), memory (score 0- 26), fluency (score 0-14), language (score 0 - 26) and visuospatial processing (0-16). The total score is 100 with higher scores indicating better cognitive functioning.
Measured: 0, 12, 24 and 36 weeks
Trail Making Test
Score for Trail Making Test. The Trail Making Test (TMT) is a timed neuropsychological test that involves visual scanning and working memory. The TMT is scored by how long it takes to complete the test (seconds). Norms have been established based on age and education and the lower the number of seconds taken the better the cognitive functioning.
Measured: 0, 12, 24 and 36 weeks
Digit Span Test
Score for Digit Span Test. This test measures short-term verbal memory. The total number of lists reported correctly is combined across forward span (FS) and backward span (BS) to produce a total correct score. Outcome measures include the direction of the task (forwards or backwards), the longest sequence successfully reached and passed, and the total number of attempts. The higher the score the better the cognitive functioning.
Measured: 0, 12, 24 and 36 weeks
24-hour time-use patterns
24-hour time use will be captured via self-report using the Multimedia Activity Recall for Children and Adults (MARCA) tool (30). The MARCA will be conducted via telephone call with a trained researcher and requires participants to recall every activity that they engaged in over the past two days from midnight to midnight, in minimum 5-minute increments. The MARCA tool contains over 500 activities linked to an activity compendium, allowing 24-hour time use to be conceptualised in terms of both activity types and activity intensities (through linking each individual activity with its metabolic equivalent per the compendium).
Measured: 0, 12 and 36 weeks
Measures of behavioural change
Participants' motivation to be physically active will be captured using the Treatment Self-Regulation Questionnaire. Participants will respond to 15 questions relating to reasons for beginning or keeping regular disease self-management, such as "Because I personally think it is best for my health" and "Because I would feel guilty or ashamed if I did not manage my own disease" using a 7-point Likert-type scale (1=not true at all, 7=completely true).
Measured: 0, 12, 24 and 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Apr 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders University
- Responsible party
- Principal investigator, A/Prof Ashleigh Smith, University of South Australia
- Investigators
- Ashleigh Smith, PhD, Principal investigator, University of South Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291909
- Sponsor's protocol ID
- 205989
- Status last verified
- Sep 2025
- First submitted
- 18 Feb 2024
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mellow ML, Blake HT, Ferguson T, Robins B, Dumuid D, Olds T, Stanford TE, Laver K, Keage H, Coates A, Wade AT, Rogers M, Davis A, Di Venuto L, Tregoweth E, Yandell C, Tainsh B, Smith AE. 'Small Steps' towards improving 24-hour time-use behaviours to decrease the risk of dementia: protocol for a personalised, web-based randomised controlled trial in community-dwelling older adults. BMJ Open. 2025 Nov 4;15(11):e105643. doi: 10.1136/bmjopen-2025-105643.
PubMed 41193209
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Steps Towards Personalized Dementia Prevention: Implementation and Evaluation of a Personalized, Technology-assisted Physical Behaviour Intervention
- ClinicalTrials.gov ID
- NCT06291909
- Acronym / sponsor ID
- 205989
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- physical activity, sleep, sedentary behavior, behavioral intervention, cognition, dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of South AustraliaUniversity, hospital or other
- Collaborators
- Flinders University
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators have previously co-designed a personalised, technology-assisted physical activity intervention called 'Small Steps', which promotes positive behaviour changes to reduce dementia risk factors. The current study aims to implement and evaluate this intervention. The 'Small Steps' website provides the tools for facilitating changes in time-use behaviours 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. Rather than considering single time-use components as independent variables, including 24-hour time-use compositions in the same analytical model will allow the inevitable interplay between the individual components to be assessed.
Older adults most at risk of dementia (older population, low physical activity levels, lower socio-economic status areas) will be recruited. Participants will be assessed face-to-face by trained research staff at study Enrolment, and completion of the Introduction, Maintenance and Follow-Up Phases (each phase is 12 weeks long). The trial will involve comprehensive assessments including detailed demographics, anthropometry and time-use assessments.
The intervention will be modelled on our previously successful method of reducing sitting time in older adults and use recommendations of the optimal activity composition generated from a previous study (ACTIVate Study, Smith et al. BMJ Open 2022;12:e047888). Older adults will be able to work with research staff to co-create interventions that are individualised for their own needs based on individual preferences, constraints and lifestyle. It is hypothesised that the Small Steps intervention will be both more effective than generic health advice (control group) and effects will hold over time (to end of the Follow Up Phase).
Hypotheses: In older adults at risk of dementia, a Small Steps intervention compared to generic health advice will be feasible and associated with:
- increased time spent in physical activity from Enrolment to end of the each phase, compared to generic health advice.
- improved cognitive functioning assessed by the Addenbrooke's Cognitive Exam.
- improved sleep quality as assessed by the Pittsburgh Sleep Quality questionnaire and Sleep Hygiene Index.
Aims:
- Assess the feasibility of a personalised technology assisted behavioural intervention to improve the 24-hour time use of older adults.
2.) Assess whether a personalised 24-hour time-use intervention increases physical activity and improves sleep behaviour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Condensed Program Group | Placebo comparator | Behavioral: Comparator ProgramIdentification 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). |
| Extended Program Group | Experimental | Behavioral: Small Steps ProgramIdentification 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Aged 65 years or older
- Ambulatory and community dwelling
- Fluent in the English Language (required for cognitive assessments)
- Resident of City of Onkaparinga Council, Marion City Council, City of Port Adelaide and Enfield, City of Playford, City of Salisbury, City of Tea Tree Gully
- Access and competency in using technology (i.e., phone, tablet, computer)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small Steps ProgramAlso: Extended ProgramParticipants 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. | Behavioural | Extended Program Group |
| Comparator ProgramAlso: Condensed ProgramParticipants 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. | Behavioural | Condensed Program Group |
Primary outcome
Number of participant logins onto the "Small Steps" website
Time frame: 0-36 weeks
Analysis of the Small Steps website will be performed to provide the number of logins for each on participant with the 'Small Steps' website. A higher the number of logins, indicates greater engagement with the website.
Number of participant check-ins on the "Small Steps" dashboard
Time frame: 0-36 weeks
Analysis of the Small Steps website will be performed to provide the number of check-ins for each on participant with the 'Small Steps' website. Participants are asked to check-in weekly at a minimum. A higher the number of logins, indicates greater engagement with the website.
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.
Time frame: 0-12 weeks
Analysis of the Small Steps website will be performed to analyse the number of behavioural change choice each participant makes within the 'Small Steps' website. A higher the number of choices, indicates greater engagement with the intervention.
Time participants spent on the "Small Steps" website
Time frame: 0-36 weeks
Analysis of the Small Steps website will be performed to analyse the time each participant spends on the 'Small Steps' website. This will be measured in minutes/login and total number of minutes. A greater number of minutes, indicates greater engagement with the intervention.
Duration of each participant behavioural change choice during the Introductory Phase
Time frame: 0-12 weeks
The duration of each behavioural change the participants choose to make at each week. The duration will be measured in minutes/day for each new behavioural change choice.
Holden's Simplified System Usability Scale
Time frame: 12 and 24 weeks
The intervention feasibility will be measured by Holden's Simplified System Usability Scale questionnaire, participant reported. The Holden's Simplified System Usability Scale is 10-item design, five-item agreement-based Likert scale, from Strongly agree (5) to Strongly disagree (1) with total scores ranging from 10- 50. It allows you to evaluate software, mobile devices, websites and applications. A higher score indicates greater usability.
Health Care Climate Questionnaire
Time frame: 12 and 24 weeks
The intervention acceptability will be measured by the Health Care Climate Questionnaire (participant reported). This is a 6 item (shortened version) using a 7-point Likert-type scale, from Not At All True (1) to Very True (7). The total scores will range from 6 - 42 and a higher score indicates greater acceptability. The preamble and wording of each item will be altered, to better align with the Small Steps intervention and the role of the health professional.
Behavioural Automaticity Questionnaire
Time frame: 0, 12, 24 and 36 weeks
The intervention acceptability feasibility will be measured by a Behavioural automaticity (Self-Report Behaviour Automaticity Index) questionnaire. Participants rate items (such as "Physical activity is something I do automatically") on a scale ranging from 1 (strongly disagree) to 7 (strongly agree). Participants will complete the measure in relation to four different behaviours; physical activity, sedentary behaviour, and good sleep practices with each of these 4 behaviours ranging in scores from 4-28. A higher score indicates greater automaticity for that behaviour.
Self-efficacy and Intention Questionnaire
Time frame: 0, 12, 24 and 36 weeks
The intervention feasibility will be measured by self-efficacy and intention questionnaire (participant reported). Participants self-efficacy for physical activity will be captured through the self-efficacy for exercise scale. Intention to be physically active and perform positive sleep behaviours will each be assessed. Participants will respond on a 7-point Likert scale with options ranging from 1 (Strongly Disagree) to 7 (Strongly Agree). The total scores will range from 7- 14, with a higher score indicating greater feasibility of the intervention.
Perceived Competence Scale
Time frame: 0, 12, 24 and 36 weeks
Participants' satisfaction of their psychological needs of competence will be assessed using the Perceived Competence Scale. This is a short 4-item questionnaire assessing participants' perceived competence to exercise. Participants respond to the 4-items using a 7-point Likert type scale, ranging from 1 (not at all true) to 7 (very true). The total scores will range from 4 - 28, with a higher score indicating greater participant confidence and feelings of competence.
Exit interview
Time frame: 36 weeks
A single Semi-structured exit interview will elicit rich data on participant experiences, perceived burden, suggestions for improvement and barriers to feasibility.
Daily activity
Time frame: 0, 12, 24 and 36 weeks
Continuous recording using a wrist-worn activity monitor (FitBit) with daily time-use derived from a 7-day average. Time spent in sedentary, light, moderate-to-vigorous and vigorous physical activity (min/day).
Sleep quality
Time frame: 0, 12, 24 and 36 weeks
Self-reported sleep quality as measured by Pittsburgh Sleep Quality Index (PSQI). The PSQI is 19-item self-report index to assess sleep quality. The questionnaire consists of a combination of Likert type and open-ended questions (later converted to scaled scores using provided guidelines). Scoring provides an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Sleep Hygiene
Time frame: 0, 12, 24 and 36 weeks
Self-reported sleep quality as measured by Sleep Hygiene Index (SHI). The SHI is a 13-item self-report index designed from the ICSD to assess the presence of sleep hygiene behaviours. Each of the item is rated on a five-point Likert scale (ranging from 0 [never] to 4 [always]). The total scores ranged from 0 to 52, with higher scores indicating poorer sleep hygiene status.
Sleep quantity
Time frame: 0, 12, 24 and 36 weeks
Continuous recording using a wrist-worn activity monitor (FitBit) with daily time-use derived from a 7-day average with sleep time measured in minutes per day.
5 secondary outcomes
Addenbrooke's Cognitive Exam III
Time frame: 0, 12, 24 and 36 weeks
Trail Making Test
Time frame: 0, 12, 24 and 36 weeks
Digit Span Test
Time frame: 0, 12, 24 and 36 weeks
24-hour time-use patterns
Time frame: 0, 12 and 36 weeks
Measures of behavioural change
Time frame: 0, 12, 24 and 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 41193209Mellow ML, Blake HT, Ferguson T, Robins B, Dumuid D, Olds T, Stanford TE, Laver K, Keage H, Coates A, Wade AT, Rogers M, Davis A, Di Venuto L, Tregoweth E, Yandell C, Tainsh B, Smith AE. 'Small Steps' towards improving 24-hour time-use behaviours to decrease the risk of dementia: protocol for a personalised, web-based randomised controlled trial in community-dwelling older adults. BMJ Open. 2025 Nov 4;15(11):e105643. doi: 10.1136/bmjopen-2025-105643.
- Individual participant dataSharing planned: No
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Dementia Caregivers, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashleigh Smith, PhD principal investigator
University of South Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Small Steps Program and Comparator Program in people with Dementia and Alzheimer Disease, run by University of South Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participant logins onto the "Small Steps" website (time frame: 0-36 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06291909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.