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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 At the completion of the 12 weeks, investigator support will be withdrawn.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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participant logins onto the "Small Steps" website — 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 — 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. — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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