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A Lifestyle Intervention Study to Reduce Modifiable Risk Factors for Dementia in People with Mild Cognitive Impairment - The COAST Study

A Feasibility Randomised Controlled Trial of a Targeted Risk-Reduction Program for People with Mild Cognitive Impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001634167
Acronym
COAST Study
Enrollment
3
Registered
2019-11-25
Start date
2020-11-01
Completion date
2023-06-30
Last updated
2022-01-17

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 COAST Study will assess the feasibility and efficacy of lifestyle intervention programs to reduce modifiable risk factors for dementia through behaviour-change in people with Mild Cognitive Impairment (MCI). The study will use three different interventions of varying intensity level - 1) delivery of risk information to change behaviour; 2) delivery of risk information plus weekly text message support to change behaviour; 3) delivery of risk information plus weekly face-to-face intervention delivered by a psychologist designed to change behaviour. Acceptability of the interventions will be assessed along with cognitive and affective outcomes. It is hypothesised that the text message support group will display greater behaviour-change than the information only group, and that the face-to-face group will show the greatest change of all three groups.

Interventions

The COAST study will use three intervention groups, each designed to reduce modifiable risk factors for dementia. The three interventions will vary in intervention intensity level, with Group 1 being low intensity, Group 2 being moderate intensity, and Group 3 being high intensity. All participants will set SMART goals for dementia risk reduction behaviour change with an experienced psychologist at the Healthy Brain Ageing (HBA) clinic located at the Sunshine Coast Mind and Neuroscience - Thomps

The COAST study will use three intervention groups, each designed to reduce modifiable risk factors for dementia. The three interventions will vary in intervention intensity level, with Group 1 being low intensity, Group 2 being moderate intensity, and Group 3 being high intensity. All participants will set SMART goals for dementia risk reduction behaviour change with an experienced psychologist at the Healthy Brain Ageing (HBA) clinic located at the Sunshine Coast Mind and Neuroscience - Thompson Institute (SCMN-TI) prior to group randomisation. Group 1 - Low intensity (n=30): A dementia risk information only active control group consisting of a comprehensive feedback report of participant's dementia risk profile as determined by comprehensive assessments conducted by experienced medical practitioner, neuropsychologist, and psychologist at the HBA clinic to participants' referring doctor. This report will be written by the HBA clinical psychologist or clinical neuropsychologist, as per standard clinical practice. In addition, individuals will be offered a 45-min appointment with a research psychologist to discuss dementia risk factors and possible risk reduction strategies. Group 2 - Medium intensity (n=30): A comprehensive feedback report outlining dementia risk will be given to the participant and GP, and participants will also be offered a 45-min appointment with a research psychologist to discuss dementia risk factors and possible risk reduction strategies (as per Group 1). In addition, participants will receive 10 weeks of text message alerts (sent weekly) regarding healthy brain ageing strategies and recommendations in order to assist participants to achieve their personalised behavior-change goals (n=30). Text messages will be personalised to each participants' goals as identified in the SMART goal setting interview conducted with the psychologist. Text message content will be selected from a pre-set menu of messages related to different dementia risk factors, with 10 messages in each category. Categories include: Physical Activity; Nutrition; Obesity and vascular risk factors; Cognitive stimulation; Depression/Anxiety; Sleep; and Smoking. Group 3 - High intensity (n=30): A comprehensive feedback report outlining dementia risk will be given to the participant and GP, and participants will be offered a 45-min appointment with a psychologist to discuss dementia risk factors and possible risk reduction strategies (as per Groups 1 and 2). In addition, participants will attend 10 weekly sessions with a psychologist. Participants allocated to Group 3 will attend the HBA clinic once weekly at a mutually agreed time to meet with a trained psychologist for one hour. Based on the results of their comprehensive assessment, individualised treatment plans will be developed via team consensus. The psychologist will initially introduce and discuss this proposed treatment plan with the participant, especially with reference to their previously set goals. The 10-week program will then be tailored and delivered by a clinical psychologist to target the most significant and relevant modifiable health and lifestyle risk factors for dementia. Potential targets for intervention include depression, cardiovascular disease, smoking, exercise, and diet as well as specific cognitive difficulties (e.g. memory or attention problems). Techniques to be utilised in each participant’s program will therefore vary based on the individualised plan, but in all cases will comprise a combination of motivational interviewing, structured problem-solving, psycho-education using both internally developed materials from the Sydney-based investigators as well as external materials such as from Dementia Australia, the Heart Foundation, Beyond Blue or the Australian Government (dietary or alcohol guidelines), and cognitive strategy training. Since this is a feasibility trial, adherence and uptake will be assessed by the HBA Program Co-ordinator according to the following criteria: 1. Feasibility of recruitment: • % of eligible people agreeing to participate in the trial. Feasibility will be defined by a 50% uptake in trial participation. 2. Feasibility of acceptability: • % of trial completers. Acceptability will be defined by 60% completion rate. Stop-Go criteria: At 6-months, feasibility and acceptability will be reviewed and if the above criteria are not met, the trial will be modified (with appropriate ethical and clinical governance approval).

Sponsors

University of the Sunshine Coast
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Individuals aged 60-85 years who meet the Winblad criteria for mild cognitive impairment (MCI) as tested at the HBA clinic; 2. Able to engage in the study over a period of three months including attendance at the Thompson Institute on a weekly basis over a 12-week period. 3. Willingness to undergo cognitive testing, actigraphy, complete self-report questionnaires, and an MRI scan (pass MRI safety checklist) at baseline and post-intervention. 4. Access to and ability to use mobile phone for text message alerts.

Exclusion criteria

Individuals with any of the following will be excluded from participation: 1. Prior head injury with loss of consciousness >30 minutes 2. Stroke or TIA with any residual cognitive, physical, or functional impairment. 3. Heart disease, Atherosclerosis, or any other heart/vascular condition 4. History of schizophrenia or non-affective psychiatric disorder (eg: ADHD, CFS, PTSD). 5. Acute psychosis. 6. Major neurological condition, such as Parkinson’s disease, epilepsy etc. 7. Current or past alcohol or other substance misuse. 8. Intellectual disability. 9. Insufficient English language skills to complete standardised assessment. 10. Involved in another clinical trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026