protocolSection identificationModule nctId: NCT06291909, orgStudyIdInfo id: 205989, briefTitle: Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of South Australia, class: OTHER, collaborators name: Flinders University, descriptionModule briefSummary: 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., conditionsModule conditions: Dementia, conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Small Steps Program, interventions name: Comparator Program, outcomesModule primaryOutcomes measure: Number of participant logins onto the "Small Steps" website, primaryOutcomes measure: Number of participant check-ins on the "Small Steps" dashboard, primaryOutcomes 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., primaryOutcomes measure: Time participants spent on the "Small Steps" website, primaryOutcomes measure: Duration of each participant behavioural change choice during the Introductory Phase, primaryOutcomes measure: Holden's Simplified System Usability Scale, primaryOutcomes measure: Health Care Climate Questionnaire, primaryOutcomes measure: Behavioural Automaticity Questionnaire, primaryOutcomes measure: (Behavioural Regulation in Exercise Questionnaire, primaryOutcomes measure: Self-efficacy and Intention Questionnaire, primaryOutcomes measure: Perceived Competence Scale, primaryOutcomes measure: Exit interview, primaryOutcomes measure: Daily activity, primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Sleep Hygiene, primaryOutcomes measure: Sleep quantity, secondaryOutcomes measure: Addenbrooke's Cognitive Exam III, secondaryOutcomes measure: Trail Making Test, secondaryOutcomes measure: Digit Span Test, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Australia, status: RECRUITING, city: Adelaide, state: South Australia, zip: 5001, country: Australia, contacts name: Catherine Yandell, PhD, role: CONTACT, phone: +61 8 83022109, email: catherine.yandell@unisa.edu.au, contacts name: Emma Waters, BSc(Hon), role: CONTACT, contacts name: Ashleigh Smith, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Maddison Mellow, PhD, role: SUB_INVESTIGATOR, contacts name: Dorothea Dumuid, PhD, role: SUB_INVESTIGATOR, contacts name: Tyman Stanford, PhD, role: SUB_INVESTIGATOR, contacts name: Timothy Olds, PhD, role: SUB_INVESTIGATOR, contacts name: Hannah Keage, PhD, role: SUB_INVESTIGATOR, contacts name: Ross Smith, PhD, role: SUB_INVESTIGATOR, contacts name: Alison Coates, PhD, role: SUB_INVESTIGATOR, contacts name: Michelle Rogers, PhD, role: SUB_INVESTIGATOR, contacts name: Catherine Yandell, PhD, role: SUB_INVESTIGATOR, contacts name: Emma Waters, BSc(Hon), role: SUB_INVESTIGATOR, contacts name: Kate Laver, PhD, role: SUB_INVESTIGATOR, contacts name: Alexander Wade, PhD, role: SUB_INVESTIGATOR, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False