Clinical trial NCT06291909: Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia
Official title: Small Steps Towards Personalized Dementia Prevention: Implementation and Evaluation of a Personalized, Technology-assisted Physical Behaviour Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Keywords: physical activity
sleep
sedentary behavior
behavioral intervention
cognition
dementia
Lead sponsor: University of South Australia
Sponsor class: OTHER
Collaborators: name: Flinders University
First posted: 2024-03-04
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Number of participant logins onto the "Small Steps" website
timeFrame: 0-36 weeks
measure: Number of participant check-ins on the "Small Steps" dashboard
timeFrame: 0-36 weeks
measure: 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.
timeFrame: 0-12 weeks
measure: Time participants spent on the "Small Steps" website
timeFrame: 0-36 weeks
measure: Duration of each participant behavioural change choice during the Introductory Phase
timeFrame: 0-12 weeks
measure: Holden's Simplified System Usability Scale
timeFrame: 12 and 24 weeks
measure: Health Care Climate Questionnaire
timeFrame: 12 and 24 weeks
measure: Behavioural Automaticity Questionnaire
timeFrame: 0, 12, 24 and 36 weeks
measure: (Behavioural Regulation in Exercise Questionnaire
timeFrame: 0, 12, 24 and 36 weeks
measure: Self-efficacy and Intention Questionnaire
timeFrame: 0, 12, 24 and 36 weeks
measure: Perceived Competence Scale
timeFrame: 0, 12, 24 and 36 weeks
measure: Exit interview
timeFrame: 36 weeks
measure: Daily activity
timeFrame: 0, 12, 24 and 36 weeks
measure: Sleep quality
timeFrame: 0, 12, 24 and 36 weeks
measure: Sleep Hygiene
timeFrame: 0, 12, 24 and 36 weeks
measure: Sleep quantity
timeFrame: 0, 12, 24 and 36 weeks
Secondary outcomes:
measure: Addenbrooke's Cognitive Exam III
timeFrame: 0, 12, 24 and 36 weeks
measure: Trail Making Test
timeFrame: 0, 12, 24 and 36 weeks
measure: Digit Span Test
timeFrame: 0, 12, 24 and 36 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of South Australia
state: South Australia
Study officials:
affiliation: University of South Australia
name: Ashleigh Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: