Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia

NCT ID: NCT06291909

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-03
• Study Completion Date: 2027-01-31

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.

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:

1. increased time spent in physical activity from Enrolment to end of the each phase, compared to generic health advice.

2. improved cognitive functioning assessed by the Addenbrooke's Cognitive Exam.

3. improved sleep quality as assessed by the Pittsburgh Sleep Quality questionnaire and Sleep Hygiene Index.

Aims:

1) 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Comparator Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Small Steps Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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 Type: BEHAVIORAL

Other Intervention Names

Extended Program; Condensed Program

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Flinders University

OTHER

Sponsor Role: collaborator

University of South Australia

OTHER

Sponsor Role: lead

Responsible Party

A/Prof Ashleigh Smith

Associate Professor in Healthy Ageing, UniSA Allied Health & Human Performance

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashleigh Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Australia

Locations

University of South Australia

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

205989

Identifier Type: -

Identifier Source: org_study_id