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Effectiveness of a lifestyle intervention on cognitive decline in people with mild cognitive problems:The CogCoach-Brain trial

Effectiveness of the CogCoach-Brain multidomain lifestyle intervention on cognitive decline in adults aged 60 years and older with subjective cognitive decline and mild cognitive impairment

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000618358
Acronym
CogCoach-Brain
Enrollment
788
Registered
2026-05-20
Start date
2026-10-01
Completion date
2027-11-30
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The CogCoach Brain project aims to evaluate an online, evidence-based lifestyle intervention designed to promote healthy brain ageing and reduce dementia risk in older adults with subjective cognitive decline (SCD) or mild cognitive impairment (MCI). Building on the CogCoach-Health framework, the program delivers a 12-week multidomain intervention targeting physical activity, cognitive engagement, diet, social connection, sleep, and mood through interactive e-learning modules and personalised behavioural support. The randomised controlled trial follows participants for 12 and 24 months to assess long-term changes in cognitive function, lifestyle behaviours, and wellbeing. Optional biomarker testing will explore how lifestyle modification may influence biological indicators of brain health. The overarching goal is to provide an accessible, scalable program that supports healthy brain ageing and reduces dementia risk in older Australians

Interventions

The CogCoach Brain Online Intervention Includes the follow E-learning: Participants will complete a 12-week online education program focused on reducing dementia risk. The e-learning component includes six self-paced online modules ("Chapters"), each taking approximately 30–40 minutes to complete. The modules cover the following topics: 1. Introduction to the course and healthy brain ageing 2. Looking After Your Memory 3. Physical Activity 4. Healthy Diet 5. Staying Cognitively and Socially

The CogCoach Brain Online Intervention Includes the follow E-learning: Participants will complete a 12-week online education program focused on reducing dementia risk. The e-learning component includes six self-paced online modules ("Chapters"), each taking approximately 30–40 minutes to complete. The modules cover the following topics: 1. Introduction to the course and healthy brain ageing 2. Looking After Your Memory 3. Physical Activity 4. Healthy Diet 5. Staying Cognitively and Socially Active 6. Stress Reduction Each module provides background information on the topic, along with interactive activities, reflection prompts, and goal-setting exercises to support behaviour change. Interactive activities include things such as quizzes to test knowledge, reflective exercises, goal-setting tasks (e.g., setting weekly goals). Intervention participants will receive access to these modules during Weeks 1, 2, 4, 6, 8, and 10 of the programs. Telehealth Consultations a) Cognitive Engagement Consultation: One session on cognitive engagement will be delivered by a research assistant with at least four years of psychology training. Sessions will be conducted individually via videoconferencing or, where not possible, by phone, and will last up to one hour. This consultation will occur in Week 1 or as soon as possible after randomisation. It includes discussion and planning of a Cognitive Diary and goal setting related to cognitively stimulating activities. Participants will also receive guidance on using BrainHQ for cognitive training. They will be given a 12-month BrainHQ subscription at the beginning of the intervention and will be encouraged to complete two executive-function tasks and two memory tasks per week (up to two hours of training) for up to 2 hours per week. Example executive function training tasks include the Double Decision task, participants are shown a car briefly at the centre of the screen and a road sign in the periphery. After the display disappears, they are shown two car options and are required to identify which car was presented, as well as indicate the location of the road sign. In the Juggle Factor task, participants are presented with a sequence of numbers that are placed within moving circles; they are required to reconstruct the sequence in the correct order and in the correct locations. An example Memory training task is Memory Grid in which participants are shown a grid of cards with associated sounds and are required to click on cards and match pairs by remembering their locations and sounds. b) Physical Activity Consultations Two consultations on physical activity will be delivered by an accredited exercise physiologist (EP). Each session will be conducted individually via videoconferencing or, where not possible, by phone, and will last up to 45 minutes. Sessions will occur approximately in Weeks 5 and 9. The first session involves development of a personalised exercise plan based on the Australian physical activity guidelines. The second session focuses on reviewing progress, supporting goal attainment, and troubleshooting barriers. Where appropriate, the EP will introduce Physitrack or the StandingTall app to support ongoing physical activity. These apps provide guided digital exercise programs delivered via a tablet or mobile device, with instructions, cues, and difficulty levels adapted to the participant’s needs. Participants may use their own device or one supplied by the study. c) Dietary Consultations Two consultations on diet will be delivered by a qualified dietitian. Sessions will be conducted individually via videoconferencing or, where not possible, by phone, and will last up to 1 hour each. They will occur approximately in Weeks 7 and 11. The first session focuses on developing an individualised dietary plan and setting goals based on the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet. The MIND diet emphasises consumption of unprocessed fruit and vegetables, whole grains, nuts, olive oil, fish, legumes, and low consumption of red meat. Dietary adaptations will be made to ensure cultural suitability. The second session involves reviewing progress and adjusting strategies to support participants in achieving their dietary goals. Telehealth Booster Sessions Telehealth booster sessions will be conducted at approximately 4 months, 9 months and again at approximately 18 months following completion of the e-learning program. These sessions will be delivered via videoconference wherever possible, or by phone as an alternative, and will last approximately 45 minutes each. Booster sessions will follow a standardised template based on motivational interviewing principles, focusing on reviewing goals, discussing progress, addressing challenges, and supporting continued behaviour change. Each session will also include a brief recap of key intervention materials. Adherence: Adherence to the e-learning components will be monitored using website analytics (e.g., time spent on each chapter, number of chapters completed, number of interactive activities completed). We will also record whether participants choose not to attend consultations or engage in cognitive training. To encourage adherence, reminder emails will be sent to participants who have not completed a chapter. Access to subsequent chapters will not be restricted based on completion of earlier modules. Process Evaluation Process evaluation will be embedded within the e-learning modules through questions assessing participants’ familiarity with the topics, willingness to change behaviour, and perceptions of health. Across the modules and booster sessions, we will also collect information on goals set by participants and their general feedback on the program. Biomarker Collection A subsample of participants from both the intervention and active control groups will be invited to take part in an optional biomarker collection. Consenting participants will provide blood samples at baseline and again at 24 months post intervention. The biomarkers to be assessed at baseline and 24 months post intervention include measures of proteins associated with Alzheimer's disease (plasma Aß42/40, p-tau217), markers of neurodegeneration (neurofilament light), astrogliosis (GFAP), and general inflammation (c-reactive protein). Participation in this component is voluntary and does not affect involvement in the main trial. In addition, APOE4 genotype will be obtained from the baseline data collection but is not a trial outcome measure.

Sponsors

University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• 60 years of age or older • Presence of subjective cognitive decline (SCD), defined as an ECog-12 score < 1.54, or cognitive performance consistent with mild cognitive impairment (MCI), defined by a T-MoCA score > 13/22 and < 19/22. • Ability to read, write and communicate in English to a comfortable level • At least one of the following risk factors: insufficient physical activity, poor diet or low levels of cognitive engagement • Willingness to nominate a friend, family or carer who is willing to provide information about the participant’s memory and thinking and their everyday behaviour at the beginning and end of the study. • Willingness to complete an online course, lifestyle factor questionnaires and interviews over phone/video call with ability to connect to the internet • No current diagnosed psychiatric or neurological disorders (other than MCI)

Exclusion criteria

• Clinician-confirmed or self-reported dementia • Severe cognitive impairment, defined as an age- and education-adjusted T-MoCA score < 13 out of 22 • Currently participating in a similar healthy ageing intervention • Medical or psychiatric conditions that would adversely impact participation in the trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 11, 2026