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

NCT06291909 | Active Not Recruiting

• 1 other identifier: 205989
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimer Disease

Keywords

physical activity; sleep; sedentary behavior; behavioral intervention; cognition; dementia

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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.

  0, 12, 24 and 36 weeks

Secondary Outcomes (5)

• Addenbrooke's Cognitive Exam III

  0, 12, 24 and 36 weeks

• Trail Making Test

  0, 12, 24 and 36 weeks

• Digit Span Test

  0, 12, 24 and 36 weeks

• 24-hour time-use patterns

  0, 12 and 36 weeks

• Measures of behavioural change

  0, 12, 24 and 36 weeks

Study Arms (2)

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).

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.

Behavioral: Small Steps Program

Interventions

Small Steps Program 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.

Also known as: Extended Program

Extended Program Group

Comparator Program 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.

Also known as: Condensed Program

Condensed Program Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Australia: lead
• Flinders University: collaborator

Study Sites (1)

University of South Australia

Adelaide, South Australia, 5001, Australia

Location

Related Publications (1)

• 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.

  PMID: 41193209 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Ashleigh Smith, PhD

  University of South Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Healthy Ageing, UniSA Allied Health & Human Performance

Study Record Dates

• First Submitted: February 18, 2024
• First Posted: March 4, 2024
• Study Start: April 3, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)